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Feasibility Studies in Psychiatry

Exploring current smartphone-based cognitive assessments in schizophrenia and bipolar disorder
Lane E, Joshi D, Guimond S, Moore R, Ahmed AO, Ajilore O and Torous J
Schizophrenia and bipolar disorder are associated with cognitive deficits that contribute significantly to disability. However, traditional in-lab cognitive assessments are time-consuming and not optimized for remote administration. Recent advancements in smartphone technology enable momentary cognitive assessments in a real-world context. This brief report reviews recent research in momentary cognitive assessments in individuals with schizophrenia and bipolar disorder through reviewing mobile platforms and cognitive assessments studied. A total of 14 experimental articles were reviewed, focusing on cognitive domains including visual working memory, processing speed, executive function, verbal fluency, verbal memory, social cognition, and typing patterns. The review highlights the feasibility of remote cognitive assessment with smartphones, and provides a layout of domains studied in this context, but illustrates a low volume of current research, the need for additional studies, and the potential for innovations like digital phenotyping.
Volumetric brain MRI signatures of heart failure with preserved ejection fraction in the setting of dementia
Bermudez C, Kerley CI, Ramadass K, Farber-Eger EH, Lin YC, Kang H, Taylor WD, Wells QS and Landman BA
Heart failure with preserved ejection fraction (HFpEF) is an important, emerging risk factor for dementia, but it is not clear whether HFpEF contributes to a specific pattern of neuroanatomical changes in dementia. A major challenge to studying this is the relative paucity of datasets of patients with dementia, with/without HFpEF, and relevant neuroimaging. We sought to demonstrate the feasibility of using modern data mining tools to create and analyze clinical imaging datasets and identify the neuroanatomical signature of HFpEF-associated dementia. We leveraged the bioinformatics tools at Vanderbilt University Medical Center to identify patients with a diagnosis of dementia with and without comorbid HFpEF using the electronic health record. We identified high resolution, clinically-acquired neuroimaging data on 30 dementia patients with HFpEF (age 76.9 ± 8.12 years, 61% female) as well as 301 age- and sex-matched patients with dementia but without HFpEF to serve as comparators (age 76.2 ± 8.52 years, 60% female). We used automated image processing pipelines to parcellate the brain into 132 structures and quantify their volume. We found six regions with significant atrophy associated with HFpEF: accumbens area, amygdala, posterior insula, anterior orbital gyrus, angular gyrus, and cerebellar white matter. There were no regions with atrophy inversely associated with HFpEF. Patients with dementia and HFpEF have a distinct neuroimaging signature compared to patients with dementia only. Five of the six regions identified in are in the temporo-parietal region of the brain. Future studies should investigate mechanisms of injury associated with cerebrovascular disease leading to subsequent brain atrophy.
Effectiveness of internet-delivered cognitive behavioural therapy for anxiety and obsessive-compulsive disorders within routine clinical care in rural Sweden
Vigerland S, Fredlander S, Aspvall K, Jolstedt M, Lenhard F, Mataix-Cols D, Ljótsson B and Serlachius E
Few studies have evaluated the implementation of ICBT in regular child and adolescent mental health services (CAMHS). This study aimed to explore the acceptability, feasibility, and effectiveness of ICBT for children and adolescents with anxiety disorders and obsessive-compulsive disorder (OCD) within a rural CAMHS. The study also explored outcome predictors and long-term outcomes. Eighty-three participants were consecutively recruited from a non-specialized CAMHS in Region Jämtland Härjedalen in northern Sweden. Therapist-guided ICBT was offered during 12 weeks to children aged 8-17 with an anxiety disorder or OCD. Acceptability and feasibility measures included treatment adherence, treatment satisfaction, and adverse events. The primary outcome measure was the Clinical Global Impression-Severity. Secondary measures of effectiveness included clinician-, self-, and parent-ratings of symptom severity and functional impairment. Assessments were completed at baseline, post-treatment, and three-month follow-up (primary endpoint). A two-year follow up was conducted using medical records. Potential predictors included both patient characteristics and treatment variables. Results indicated that ICBT was both acceptable and feasible according to study measures. Statistically significant improvements were found from baseline to the three-month follow-up on clinician rated severity ( [SE] = -0.92 [0.09];  < .001), as well as on all secondary measures. Forty-three percent of participants no longer fulfilled criteria for their principal disorder at the three-month follow-up. No serious adverse events were reported. Clinical improvement was highest among children with higher functioning at baseline ( [SE] = -0.05 [0.02];  < .05). Forty-six percent of participants had been in contact with CAMHS during the two-year follow-up period, mainly for reasons other than their initial diagnosis. Findings suggest that ICBT could be an acceptable and feasible treatment option for young people with anxiety disorders and OCD in rural non-specialized CAMHS settings. Further studies are needed to confirm treatment effectiveness in this setting. Trial registration: NCT02926365.
How to support peer resistance in adolescents with mild-to-borderline intellectual disability? Intervention development and feasibility
Wagemaker E, Salemink E, Huizenga HM, Bart HF, Dekkers TJ and Bexkens A
Adolescents with mild-to-borderline intellectual disability face peer resistance challenges, risking harmful or dangerous situations.
Exploring the impact of trauma-adapted yoga in forensic psychiatry
Kerekes N
The specialized field of forensic psychiatry deals with the care of criminal offenders who suffer from severe mental disorders. As this field is positioned at the intersection of illness, crime, and security, it poses complex challenges. While high-quality clinical studies in forensic psychiatry settings are limited, recent investigations have suggested yoga as a complementary clinical tool within correctional environments. This report of a quasi-experimental study examines the impact of a 10-week trauma-adapted yoga intervention on mental health, antisocial and aggressive behaviors, pain perception, cravings, and character maturity among 56 patients in various forensic psychiatry clinics across Sweden. In the current study, the yoga group demonstrated noteworthy reductions in negative affect states, anxiety, phobic anxiety, paranoid ideations, interpersonal sensitivity, hostility, and overall psychological distress. These reductions were not observed in the comparison group. Additionally, the yoga group exhibited a significant decrease in pain frequency and strengthened self-directedness. However, there were no significant changes in aggressive, antisocial, or self-harm behaviors or cravings in either group. The between-group analyses did not yield significant results, except for pain intensity. The trauma-adapted yoga intervention implemented within forensic psychiatry settings shows feasibility and results in multiple positive changes in patients' health.
Validation of the structured interview section of the penn computerized adaptive test for neurocognitive and clinical psychopathology assessment (CAT GOASSESS)
Zoupou E, Moore TM, Kennedy KP, Calkins ME, Gorgone A, Sandro AD, Rush S, Lopez KC, Ruparel K, Daryoush T, Okoyeh P, Savino A, Troyan S, Wolf DH, Scott JC, Gur RE and Gur RC
Large-scale studies and burdened clinical settings require precise, efficient measures that assess multiple domains of psychopathology. Computerized adaptive tests (CATs) can reduce administration time without compromising data quality. We examined feasibility and validity of an adaptive psychopathology measure, GOASSESS, in a clinical community-based sample (N = 315; ages 18-35) comprising three groups: healthy controls, psychosis, mood/anxiety disorders. Assessment duration was compared between the Full and CAT GOASSESS. External validity was tested by comparing how the CAT and Full versions related to demographic variables, study group, and socioeconomic status. The relationships between scale scores and criteria were statistically compared within a mixed-model framework to account for dependency between relationships. Convergent validity was assessed by comparing scores of the CAT and the Full GOASSESS using Pearson correlations. The CAT GOASSESS reduced interview duration by more than 90 % across study groups and preserved relationships to external criteria and demographic variables as the Full GOASSESS. All CAT GOASSESS scales could replace those of the Full instrument. Overall, the CAT GOASSESS showed acceptable psychometric properties and demonstrated feasibility by markedly reducing assessment time compared to the Full GOASSESS. The adaptive version could be used in large-scale studies or clinical settings for intake screening.
The importance of decomposing periodic and aperiodic EEG signals for assessment of brain function in a global context
Del Bianco T, Haartsen R, Mason L, Leno VC, Springer C, Potter M, Mackay W, Smit P, Plessis CD, Brink L, Johnson MH, Murphy D, Loth E, Odendaal H and Jones EJH
Measures of early neuro-cognitive development that are suitable for use in low-resource settings are needed to enable studies of the effects of early adversity on the developing brain in a global context. These measures should have high acquisition rates and good face and construct validity. Here, we investigated the feasibility of a naturalistic electroencephalography (EEG) paradigm in a low-resource context during childhood. Additionally, we examined the sensitivity of periodic and aperiodic EEG metrics to social and non-social stimuli. We recorded simultaneous 20-channel EEG and eye-tracking in 72 children aged 4-12 years (45 females) while they watched videos of women singing nursery rhymes and moving toys, selected to represent familiar childhood experiences. These measures were part of a feasibility study that assessed the feasibility and acceptability of a follow-up data collection of the South African Safe Passage Study, which tracks environmental adversity and brain and cognitive development from before birth up until childhood. We examined whether data quantity and quality varied with child characteristics and the sensitivity of varying EEG metrics (canonical band power in the theta and alpha band and periodic and aperiodic features of the power spectra). We found that children who completed the EEG and eye-tracking assessment were, in general, representative of the full cohort. Data quantity was higher in children with greater visual attention to the stimuli. Out of the tested EEG metrics, periodic measures in the theta frequency range were most sensitive to condition differences, compared to alpha range measures and canonical and aperiodic EEG measures. Our results show that measuring EEG during ecologically valid social and non-social stimuli is feasible in low-resource settings, is feasible for most children, and produces robust indices of social brain function. This work provides preliminary support for testing longitudinal links between social brain function, environmental factors, and emerging behaviors.
Ventromedial prefrontal cortex activation and neurofeedback modulation during episodic future thinking for individuals with suicidal thoughts and behaviors
Aupperle RL, Kuplicki R, Tsuchiyagaito A, Akeman E, Sturycz-Taylor CA, DeVille D, Lasswell T, Misaki M, Berg H, McDermott TJ, Touthang J, Ballard ED, Cha C, Schacter DL and Paulus MP
Individuals experiencing suicidal thoughts and behaviors (STBs) show less specificity and positivity during episodic future thinking (EFT). Here, we present findings from two studies aiming to (1) further our understanding of how STBs may relate to neural responsivity during EFT and (2) examine the feasibility of modulating EFT-related activation using real-time fMRI neurofeedback (rtfMRI-nf). Study 1 involved 30 individuals with major depressive disorder (MDD; half with STBs) who performed an EFT task during fMRI, for which they imagined personally-relevant future positive, negative, or neutral events. Positive EFT elicited greater ventromedial prefrontal cortex (vmPFC) activation compared to negative EFT. Importantly, the MDD + STB group exhibited reduced vmPFC activation across all EFT conditions compared to MDD-STB; although EFT fluency and subjective experience remained consistent across groups. Study 2 included rtfMRI-nf focused on vmPFC modulation during positive EFT for six participants with MDD + STBs. Results support the feasibility and acceptability of the rtfMRI-nf protocol and quantitative and qualitative observations are provided to help inform future, larger studies aiming to examine similar neurofeedback protocols. Results implicate vmPFC blunting as a promising treatment target for MDD + STBs and suggest rtfMRI-nf as one potential technique to explore for enhancing vmPFC engagement.
Telehealth for Indigenous Children Worldwide: A Scoping Review
Kabbes N, Bugra A, Wissanji H and Osmanlliu E
Indigenous children worldwide face healthcare disparities due, in part, to resource scarcity in remote settings which may be mitigated with technology. This study aims to determine the use of telehealth for this population, with respect to feasibility, acceptability, and the degree of patient/family involvement in reported interventions. We focused on the use of telehealth to support perioperative care.
The feasibility of an adapted virtual mindfulness intervention for Special Olympics athletes and their caregivers
Redquest B, Clark CA, Sanguino H, Lunsky Y, Hutton S, Weiss J, Davies T and McMorris CA
Virtual mindfulness may be helpful for individuals with intellectual disabilities in the context of COVID-related disruptions of in-person programming, such as Special Olympics (SO). This study examined the feasibility of a virtual mindfulness intervention for SO athletes and their caregivers.
Daily and Momentary Associations Between Gender Minority Stress and Resilience With Alcohol Outcomes
Dermody SS, Uhrig A, Wardell JD, Tellez C, Raessi T, Kovacek K, Hart TA, Hendershot CS and Abramovich A
Minority stressors have been linked with alcohol use among transgender and gender diverse (TGD); however, no ecological momentary assessment studies have examined daily links between minority stress and alcohol use specifically among TGD. This study examined gender minority stressors and resilience as predictors of same-day or momentary alcohol-related outcomes. Feasibility and acceptability of procedures were evaluated.
Mi Sleep Coach Mobile App to Address Insomnia Symptoms Among Cancer Survivors: Single-Arm Feasibility Study
Arring N, Barton DL, Lafferty C, Cox B, Conroy DA and An L
Rates of sleep disturbance among survivors of cancer are more than 3 times higher than the general population. Causes of sleep disturbance among survivors are many and multifaceted, including anxiety and fear related to cancer diagnosis and treatments. Cognitive behavioral therapy for insomnia (CBT-I) is considered a first-line treatment for insomnia; However, a lack of access to trained professionals and limited insurance coverage for CBT-I services has limited patient access to these effective treatments. Evidence supports digital delivery of CBT-I (dCBT-I), but there is only limited evidence to support its use among survivors of cancer. Broad adoption of smartphone technology provides a new channel to deliver dCBT-I, but no prior studies have evaluated mobile dCBT-I interventions for survivors. To address the need for accessible and efficacious CBT-I for survivors of cancer, the Mi Sleep Coach program was developed to adapt CBT-I for delivery to survivors of cancer as a self-directed mobile health app.
Gender and Autism Program: A novel clinical service model for gender-diverse/transgender autistic youth and young adults
Strang JF, Fischbach AL, Rao S, Clawson A, Knauss M, Bernstein SN, van der Miesen AIR, Inge AP, Alonzo K, Zeroth J, Kenworthy L, Morgan CI, Brandt A, Moore CC, Ahlers K, Jankowski MK, McClellan LS, Henise SB, Cap CJ, Exley SL, Youmatz A, Song M, McLaren JL and Parchem B
Situated in Children's National Hospital (CNH)'s Neuropsychology Division, the Gender and Autism Program (GAP) is the first clinical service dedicated to the needs of autistic gender-diverse/transgender youth. This study describes GAP clinical assessment profiles and presents a multi-perspective programmatic review of GAP evaluation services. Seventy-five consecutive gender- and neuropsychologically-informed GAP evaluations were analyzed, including demographics, gender and autism characterization, and primary domains evaluated. Three program-based Delphi studies were conducted and identify: clinician priorities and challenges in providing care, program administrator lessons learned and ongoing barriers, and considerations adapting this model for a rural academic medical center. Nearly two-thirds of referrals were transfeminine. Most youth had existing autism diagnoses; of those undiagnosed, three-quarters were found to be autistic. Five goals of evaluations were identified: Mental health was always assessed, and most evaluations also assessed gender-related needs in the context of autism neurodiversity. Neuropsychological characterization of strengths and challenges informed personalized accommodations to support youth gender-related self-advocacy. Clinicians emphasized frequent youth safety concerns. Administrators emphasized the need for specialized training for working with families. Components for adaptation of the GAP in a rural academic medical center were identified. Since its founding, the GAP has proven a sustainable neuropsychology-based service with consistent referral flow and insurance authorizations. Capturing staff perspectives through rigorous Delphi methods, and addressing the GAP's feasibility and replicability, this study provides a road map for replicating this service. We also highlight GAP training of specialist clinicians, fundamental to addressing the desperate shortage of providers in this field.
Use of Electronic Health Record-Based Measures to Assess Quality of Care for Pediatric Agitation
Hoffmann JA, Corboy JB, Liu L, Cieslak K, Pergjika A, Patel TR, Bardach NS and Alpern ER
Acute agitation during pediatric mental health emergency department (ED) visits presents safety risks to patients and staff. We previously convened multidisciplinary stakeholders who prioritized 20 proposed quality measures for pediatric acute agitation management. Our objectives were to assess feasibility of evaluating performance on these quality measures using electronic health record (EHR) data and to examine performance variation across 3 EDs.
Bright light therapy versus physical exercise to prevent co-occurring depression in adolescents and young adults with attention-deficit/hyperactivity disorder: a multicentre, three-arm, randomised controlled, pilot phase-IIa trial
Mayer JS, Kohlhas L, Stermann J, Medda J, Brandt GA, Grimm O, Pawley AD, Asherson P, Sanchez JP, Richarte V, Bergsma D, Koch ED, Muntaner-Mas A, Ebner-Priemer UW, Kieser M, Retz W, Ortega FB, Colla M, Buitelaar JK, Kuntsi J, Ramos-Quiroga JA, Reif A and Freitag CM
Depression is common in attention-deficit/hyperactivity disorder (ADHD), but preventive behavioural interventions are lacking. This randomised controlled, pilot phase-IIa trial aimed to study a physical exercise intervention (EI) and bright light therapy (BLT)-both implemented and monitored in an individual, naturalistic setting via a mobile health (m-health) system-for feasibility of trial design and interventions, and to estimate their effects on depressive symptoms in young people with ADHD. Two hundred seven participants aged 14-45 years were randomised to 10-week add-on intervention of either BLT (10,000 lx; daily 30-min sessions) (n = 70), EI (aerobic and muscle-strengthening activities 3 days/ week) (n = 69), or treatment-as-usual (TAU) (n = 68), of whom 165 (80%) were retained (BLT: n = 54; EI: n = 52; TAU: n = 59). Intervention adherence (i.e. ≥ 80% completed sessions) was very low for both BLT (n = 13, 22%) and EI (n = 4, 7%). Usability of the m-health system to conduct interventions was limited as indicated by objective and subjective data. Safety was high and comparable between groups. Changes in depressive symptoms (assessed via observer-blind ratings, Inventory of Depressive Symptomatology) between baseline and end of intervention were small (BLT: -0.124 [95% CI: -2.219, 1.971], EI: -2.646 [95% CI: -4.777, -0.515], TAU: -1.428 [95% CI: -3.381, 0.526]) with no group differences [F(2,153) = 1.45, p = 0.2384]. These findings suggest that the m-health approach did not achieve feasibility of EI and BLT in young people with ADHD. Prior to designing efficacy studies, strategies how to achieve high intervention adherence should be specifically investigated in this patient group. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03371810, 13 December 2017.
The efficacy of heart rate variability biofeedback training on sleep disorders and impact of fibromyalgia: Results of a phase II randomized controlled trial
Carta MG, Testa G, Stocchino S, Finco G, Sancassiani F, Littera MT, Deidda MC, Ventriglio A, Bhugra D and Cossu G
Fibromyalgia syndrome (FMs) is a chronic, musculoskeletal pain disorder characterized by sleep disturbances, fatigue, and cognitive dysfunction. Heart rate variability biofeedback (HRV-BF) aiming to improve self-regulation and strengthen the parasympathetic nervous system has been shown to be effective in several pain syndromes, but its efficacy in FMs has not been adequately investigated. This Phase II trial aimed to assess the feasibility and preliminary measurement of the improvement induced by HRV-BF in FMs.
Acceptability and experience of a smartphone symptom monitoring app for people with psychosis in China (YouXin): a qualitative study
Zhang X, Lewis S, Chen X, Zhou J, Wang X and Bucci S
Access to high-quality mental healthcare remains challenging for people with psychosis globally, including China. Smartphone-based symptom monitoring has the potential to support scalable mental healthcare. However, no such tool, until now, has been developed and evaluated for people with psychosis in China. This study investigated the acceptability and the experience of using a symptom self-monitoring smartphone app (YouXin) specifically developed for people with psychosis in China.
Interventions for behavioral health comorbidities in the hospice setting: a scoping review
Brody L, Sadowska K, Ekwebelem M, Hollingsworth A, Ong M, Subramanian T, Wright D, Phongtankuel V, Reid MC, Silva MD and Shalev D
Behavioral health (BH) comorbidities in hospice patients are widespread and impact important outcomes, including symptom burden, quality of life, and caregiver wellbeing. However, evidencebased BH interventions tailored for the hospice setting remain understudied.
Implementing global positioning system trackers for people with dementia who are at risk of wandering
Doyle M, Nwofe ES, Rooke C, Seelam K, Porter J and Bishop D
The main aim of this study was to evaluate the feasibility and acceptability of using a GPS tracker to mitigate the risks associated with wandering for people with dementia and those caring for them and further evaluate the impact of trackers in delaying 24-hour care and the potential for reducing the involvement of support services, such as the police, in locating patients.
Capturing the Dynamics of Homelessness Through Ethnography and Mobile Technology: Protocol for the Development and Testing of a Smartphone Technology-Supported Intervention
Foster M, Fix GM, Hyde J, Dunlap S, Byrne TH, Sugie NF, Kuhn R, Gabrielian S, Roncarati JS, Zhao S and McInnes DK
US military veterans who have experienced homelessness often have high rates of housing transition. Disruptions caused by these transitions likely exacerbate this population's health problems and interfere with access to care and treatment engagement. Individuals experiencing homelessness increasingly use smartphones, contributing to improved access to medical and social services. Few studies have used smartphones as a data collection tool to systematically collect information about the daily life events that precede and contribute to housing transitions, in-the-moment emotions, behaviors, geographic movements, and perceived social support.
A scoping review of the literature on the application and usefulness of the Problem Management Plus (PM+) intervention around the world
Mwangala PN, Makandi M, Kerubo A, Nyongesa MK and Abubakar A
Given the high rates of common mental disorders and limited resources, task-shifting psychosocial interventions are needed to provide adequate care. One such intervention developed by the World Health Organization is Problem Management Plus (PM+).
An Opportunity to Fill a Gap for Newborn Screening of Neurodevelopmental Disorders
Chung WK, Kanne SM and Hu Z
Screening newborns using genome sequencing is being explored due to its potential to expand the list of conditions that can be screened. Previously, we proposed the need for large-scale pilot studies to assess the feasibility of screening highly penetrant genetic neurodevelopmental disorders. Here, we discuss the initial experience from the GUARDIAN study and the systemic gaps in clinical services that were identified in the early stages of the pilot study.
Empowering School Staff to Support Pupil Mental Health Through a Brief, Interactive Web-Based Training Program: Mixed Methods Study
Soneson E, Howarth E, Weir A, Jones PB and Fazel M
Schools in the United Kingdom and elsewhere are expected to protect and promote pupil mental health. However, many school staff members do not feel confident in identifying and responding to pupil mental health difficulties and report wanting additional training in this area.
Digital Navigator Training to Increase Access to Mental Health Care in Community-Based Organizations
Alon N, Perret S, Cohen A, Partiquin M, LeMelle S, Boyd C, Aguilera J, Reat C, Hough E, Walsh J, Dwyer B, Hogan J, Smith AH and Torous J
Providing human support for users of behavioral health technology can help facilitate the necessary engagement and clinical integration of digital tools in mental health care. A team conducted digital navigator training that taught participants how to promote patrons' digital literacy, evaluate and recommend health apps, and interpret smartphone data. The authors trained 80 participants from 21 organizations, demonstrating this training's feasibility, acceptability, and need. Case studies explore the implementation of this training curriculum. As technology's potential in mental health care expands, training can empower digital navigators to ensure that the use of digital tools is informed, equitable, and clinically relevant.
The feeding siblings questionnaire (FSQ): Development of a self-report tool for parents with children aged 2-5 years
Ayre SK, White MJ, Harris HA, Jansen E and Byrne RA
Over the last decade, there have been repeated calls to expand the operationalisation of food parenting practices. The conceptualisation and measurement of these practices has been based primarily on research with parent-child dyads. One unexplored dimension of food parenting pertains to the evaluation of practices specific to feeding siblings. This study describes the development and validation of the Feeding Siblings Questionnaire (FSQ) - a tool designed to measure practices in which siblings are positioned as mediators in parents' attempts to prompt or persuade a child to eat. Item development was guided by a conceptual model derived from mixed-methods research and refined through expert reviews and cognitive interviews. These interviews were conducted in two phases, where parents responded to the questionnaire primarily to test i) the readability and relevance of each item, and ii) its overall feasibility. The instrument was completed by 330 parents (96.1% mothers) in Australia with two children aged 2-5 years, and repeated by 133 parents (40.3%) two weeks later. Exploratory factor analysis was performed on baseline data. Internal consistency and test re-test reliability of the subsequent subscales were examined. Construct validity was assessed through comparisons with existing measures of food parenting practices and child eating behaviours. The final FSQ scale included 22 items, reflecting five food parenting practices: sibling competitiveness, active sibling influence, threatening unequal division of food, sibling role modelling, and vicarious operant conditioning. Internal consistency and test re-test reliability estimates were high, and there was some evidence of convergent construct validity. While its factor structure should be confirmed in a different sample, the FSQ offers a novel tool for assessing, monitoring, and evaluating feeding interactions beyond those confined to the parent-child dyad.
Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone App-Led Cognitive Behavioral Therapy for Depression Under Therapist Supervision: Open Trial
Wilhelm S, Bernstein EE, Bentley KH, Snorrason I, Hoeppner SS, Klare D, Greenberg JL, Weingarden H, McCoy TH and Harrison O
Major depressive disorder affects approximately 1 in 5 adults during their lifetime and is the leading cause of disability worldwide. Yet, a minority receive adequate treatment due to person-level (eg, geographical distance to providers) and systems-level (eg, shortage of trained providers) barriers. Digital tools could improve this treatment gap by reducing the time and frequency of therapy sessions needed for effective treatment through the provision of flexible, automated support.
Clinical performance of AI-integrated risk assessment pooling reveals cost savings even at high prevalence of COVID-19
Kamari F, Eller E, Bøgebjerg ME, Capella IM, Galende BA, Korim T, Øland P, Borup ML, Frederiksen AR, Ranjouriheravi A, Al-Jwadi AF, Mansour M, Hansen S, Diethelm I, Burek M, Alvarez F, Buch AG, Mojtahedi N, Röttger R and Segtnan EA
Individual testing of samples is time- and cost-intensive, particularly during an ongoing pandemic. Better practical alternatives to individual testing can significantly decrease the burden of disease on the healthcare system. Herein, we presented the clinical validation of Segtnan™ on 3929 patients. Segtnan™ is available as a mobile application entailing an AI-integrated personalized risk assessment approach with a novel data-driven equation for pooling of biological samples. The AI was selected from a comparison between 15 machine learning classifiers (highest accuracy = 80.14%) and a feed-forward neural network with an accuracy of 81.38% in predicting the rRT-PCR test results based on a designed survey with minimal clinical questions. Furthermore, we derived a novel pool-size equation from the pooling data of 54 published original studies. The results demonstrated testing capacity increase of 750%, 60%, and 5% at prevalence rates of 0.05%, 22%, and 50%, respectively. Compared to Dorfman's method, our novel equation saved more tests significantly at high prevalence, i.e., 28% (p = 0.006), 40% (p = 0.00001), and 66% (p = 0.02). Lastly, we illustrated the feasibility of the Segtnan™ usage in clinically complex settings like emergency and psychiatric departments.
Feasibility and acceptability of NIDUS-professional, a training and support intervention for homecare workers caring for clients living with dementia: a cluster-randomised feasibility trial
Cooper C, Zabihi S, Akhtar A, Lee T, Isaaq A, Le Novere M, Barber J, Lord K, Rapaport P, Banks S, Duggan S, Ogden M, Walters K, Orgeta V, Rockwood K, Butler LT, Manthorpe J, Dow B, Hoe J, Hunter R, Banerjee S, Budgett J and Duffy L
In the first randomised controlled trial of a dementia training and support intervention in UK homecare agencies, we aimed to assess: acceptability of our co-designed, manualised training, delivered by non-clinical facilitators; outcome completion feasibility; and costs for a future trial.
Young people's views on the acceptability and feasibility of loneliness interventions for their age group
Eager S, Johnson S, Pitman A, Uribe M, Qualter P and Pearce E
Loneliness is a frequently reported problem for young people aged 16 to 24 years old. A variety of interventions have been developed (but in most cases not extensively evaluated) to try and tackle loneliness in this age group. These include interpersonal, intrapersonal, and social approaches that vary in their content and mechanisms of action. The current study aimed to qualitatively examine young peoples' views on the acceptability and feasibility of different loneliness interventions.
Stability of transcranial magnetic stimulation electroencephalogram evoked potentials in pediatric epilepsy
She X, Nix KC, Cline CC, Qi W, Tugin S, He Z and Baumer FM
Transcranial magnetic stimulation paired with electroencephalography (TMS-EEG) can measure local excitability and functional connectivity. To address trial-to-trial variability, responses to multiple TMS pulses are recorded to obtain an average TMS evoked potential (TEP). Balancing adequate data acquisition to establish stable TEPs with feasible experimental duration is critical when applying TMS-EEG to clinical populations. Here we aim to investigate the minimum number of pulses (MNP) required to achieve stable TEPs in children with epilepsy. Eighteen children with Self-Limited Epilepsy with Centrotemporal Spikes, a common epilepsy arising from the motor cortices, underwent multiple 100-pulse blocks of TMS to both motor cortices over two days. TMS was applied at 120% of resting motor threshold (rMT) up to a maximum of 100% maximum stimulator output. The average of all 100 pulses was used as a "gold-standard" TEP to which we compared "candidate" TEPs obtained by averaging subsets of pulses. We defined TEP stability as the MNP needed to achieve a concordance correlation coefficient of 80% between the candidate and "gold-standard" TEP. We additionally assessed whether experimental or clinical factors affected TEP stability. Results show that stable TEPs can be derived from fewer than 100 pulses, a number typically used for designing TMS-EEG experiments. The early segment (15-80 ms) of the TEP was less stable than the later segment (80-350 ms). Global mean field amplitude derived from all channels was less stable than local TEP derived from channels overlying the stimulated site. TEP stability did not differ depending on stimulated hemisphere, block order, or antiseizure medication use, but was greater in older children. Stimulation administered with an intensity above the rMT yielded more stable local TEPs. Studies of TMS-EEG in pediatrics have been limited by the complexity of experimental set-up and time course. This study serves as a critical starting point, demonstrating the feasibility of designing efficient TMS-EEG studies that use a relatively small number of pulses to study pediatric epilepsy and potentially other pediatric groups.
Mobile Apps to Support Mental Health Response in Natural Disasters: Scoping Review
Ezeonu NA, Hertelendy AJ, Adu MK, Kung JY, Itanyi IU, Dias RDL, Agyapong B, Hertelendy P, Ohanyido F, Agyapong VIO and Eboreime E
Disasters are becoming more frequent due to the impact of extreme weather events attributed to climate change, causing loss of lives, property, and psychological trauma. Mental health response to disasters emphasizes prevention and mitigation, and mobile health (mHealth) apps have been used for mental health promotion and treatment. However, little is known about their use in the mental health components of disaster management.
Peer Support for Caregivers of People Living with Posterior Cortical Atrophy in Melbourne, Australia: A Feasibility Study
Mitchell A, Kelso W, Paynter C, Hayes L, Velakoulis D and Loi SM
Posterior Cortical Atrophy (PCA) is a rare form of young-onset dementia that causes early visuospatial and visuoperceptual deficits. The symptom profile of Posterior Cortical Atrophy leads to very specific care needs for those affected, who often rely on informal caregivers (including friends and family). Rare dementia support groups can be useful for both patients and their caregivers to assist with knowledge sharing, psychoeducation, and the provision of psychosocial support. Despite this, few such support groups exist. The purpose of this study was to examine a PCA support group for caregivers of individuals living with PCA. We held a structured psychoeducation support group comprised of four sessions with the aim being to provide education, strategies for the management of the disease, and peer support. Caregivers' mental health and quality of life were assessed. The results of our study showed that support group participation was a positive experience and assisted with increasing the knowledge of caregivers and fostering social connections. We suggest that peer support groups may be beneficial for both people living with PCA and their caregivers. We recommend that future quantitative and qualitative research is conducted to further assess health-promotion benefits to people living with PCA and their caregivers, and to assess their development and implementation in different contexts.
Accelerated transcranial magnetic stimulation for psychological distress in advanced cancer: A phase 2a feasibility and preliminary efficacy clinical trial
Downar J, Lapenskie J, Anderson K, Edwards J, Watt C, Dionne M, Rice J, Kabir M, Lawlor P and Downar J
Psychological and existential suffering affects many people with advanced illness, and current therapeutic options have limited effectiveness. Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective therapy for refractory depression, but no previous study has used rTMS to treat psychological or existential distress in the palliative setting.
The Development of an Oral Health Nursing Tool for Patients with a Psychotic Disorder: A Human-Centred Design with a Feasibility Test
Kuipers S, Castelein S, Kronenberg L, Veer JV' and Boonstra N
Patients with psychotic disorders frequently report oral health problems, while mental health nurses (MHNs) seem not to be fully aware of these problems and the risk factors. Therefore, this study aimed to develop supportive tools for MHNs regarding oral health to increase sensitisation among MHNs and provide MHNs with the knowledge to recognise (potential) oral health problems in patients with a psychotic disorder. We used a human-centred design in which the user, MHNs and experts by experience were placed at the centre of the research process. Problems and needs in MHNs working with patients with a psychotic disorder were addressed. To identify key issues of problems as well as needs in terms of resources, we started with focus groups ( = 9). We analysed the data thematically based on the context of patients and MHNs in practice regarding oral health, preferred oral health tools focused on MHNs, and the intended outcomes of tools. A multi-criteria decision matrix was developed and analysed ( = 9) to identify the most optimal and viable solution based on established criteria and issues that are prevalent in the work of MHNs. The most promising result was the development of a brochure with an awareness screener. The brochure with the awareness screener was developed as a low-fidelity prototype for MHNs regarding oral health in patients with a psychotic disorder based on the latest scientific evidence. After testing it, the feasibility was tested through semi-structured interviews ( = 19). MHNs and experts by experience were satisfied with the tool and provided recommendations for adjustments to the content. Significant augmentations to the brochure included a clinical lesson and a toothbrush with toothpaste for patients. We can conclude that a brochure with an awareness screener is feasible for MHNs. Future steps aiming to further refine and optimise care processes for oral health tools in MHNs should take refining eligibility criteria for psychiatric populations and the language level of the target group of a tool into account.
Implementation of an Electronic Clinical Decision Support System for the Early Recognition and Management of Dysglycemia in an Inpatient Mental Health Setting Using CogStack: Protocol for a Pilot Hybrid Type 3 Effectiveness-Implementation Randomized Controlled Cluster Trial
Patel D, Msosa YJ, Wang T, Williams J, Mustafa OG, Gee S, Arroyo B, Larkin D, Tiedt T, Roberts A, Dobson RJB and Gaughran F
Severe mental illnesses (SMIs), including schizophrenia, bipolar affective disorder, and major depressive disorder, are associated with an increased risk of physical health comorbidities and premature mortality from conditions including cardiovascular disease and diabetes. Digital technologies such as electronic clinical decision support systems (eCDSSs) could play a crucial role in improving the clinician-led management of conditions such as dysglycemia (deranged blood sugar levels) and associated conditions such as diabetes in people with a diagnosis of SMI in mental health settings.
Feasibility and Usefulness of Repetitions-In-Reserve Scales for Selecting Exercise Intensity: A Scoping Review
Bastos V, Machado S and Teixeira DS
The intensity of resistance training (RT) exercise is an important consideration for determining relevant health and performance-related outcomes. Yet, current objective exercise intensity measures present concerns in terms of viability or cost. In response to these concerns, repetition-in-reserve (RIR) scales may represent an adequate method of measuring and regulating intensity. However, no recent review has focused on how RIR scales have been used for this purpose in prior research. We prepared the present scoping review to analyze the feasibility and usefulness of RIR scales in selecting RT intensity. We conducted a systematic search in PubMed, SPORTDiscus, PsycINFO, and ClinicalTrials.gov databases (last search date April 2023) for experimental and non-experimental studies that utilized an RIR scale to measure proximity to failure in RT activities with apparently healthy individuals of any age. We qualitatively analyzed 31 studies (N = 855 mostly male adult participants) published between 2012-2023. RIR scales appeared to be contextually feasible and useful in prescribing and adjusting RT intensity. The most common trend in this research was to prescribe a target RIR and adjust the exercise load for a desired proximity to muscle failure. Additionally, when measuring proximity to failure as an outcome of interest, the literature suggests that the RIR prediction should be made close to task failure to increase its accuracy. Future research should further explore the impact of sex, RT experience, exercise selection, and muscle conditioning on the overall RIR approach.
Examining the Efficacy of Extended Reality-Enhanced Behavioral Activation for Adults With Major Depressive Disorder: Randomized Controlled Trial
Paul M, Bullock K, Bailenson J and Burns D
Major depressive disorder (MDD) is a global concern with increasing prevalence. While many evidence-based psychotherapies (EBPs) have been identified to treat MDD, there are numerous barriers to patients accessing them. Virtual reality (VR) has been used as a treatment enhancement for a variety of mental health disorders, but few studies have examined its clinical use in treating MDD. Behavioral activation (BA) is a simple yet effective and established first-line EBP for MDD that has the potential to be easily enhanced and adapted with VR technology. A previous report by our group explored the feasibility and acceptability of VR-enhanced BA in a small clinical proof-of-concept pilot. This study examines the clinical efficacy of a more immersive extended reality (XR)-enhanced BA (XR-BA) prototype. This is the first clinical efficacy test of an XR-BA protocol.
Perspective: The Impact of Fasting and Caloric Restriction on Neurodegenerative Diseases in Humans
Hansen B, Roomp K, Ebid H and Schneider JG
Neurodegenerative diseases (NDs) are characterized by the progressive functional and structural denaturation of neurons in the central and peripheral nervous systems. Despite the wide range of genetic predispositions, the increased emergence of these disorders has been associated with a variety of modifiable risk factors, including lifestyle factors. Diet has been shown to influence cognitive alterations in the elderly population with age-related brain pathologies, and specific dietary interventions might, therefore, confer preservatory protection to neural structures. Although Mediterranean and ketogenic diets have been studied, no clear guidelines have been implemented for the prevention or treatment of ND in clinical practice. Murine models have shown that intermittent fasting and caloric restriction (CR) can counteract disease processes in various age-related disorders, including NDs. The objective of this perspective is to provide a comprehensive, comparative overview of the available primary intervention studies on fasting and CR in humans with ND and to elucidate possible links between the mechanisms underlying the effects of fasting, CR, and the neuropathology of ND. We also included all currently available studies in older adults (with and without mild cognitive impairment) in which the primary endpoint was cognitive function to provide further insights into the feasibility and outcomes of such interventions. Overall, we conclude that nutritional intervention trials focusing on fasting and CR in humans with ND have been neglected, and more high-quality studies, including longitudinal clinical intervention trials, are urgently needed to elucidate the underlying immune-metabolic mechanisms in diet and ND.
A Web-Based Intervention Based on Acceptance and Commitment Therapy for Family Caregivers of People With Dementia: Mixed Methods Feasibility Study
Atefi GL, van Knippenberg RJM, Bartels SL, Losada-Baltar A, Márquez-González M, Verhey FRJ and de Vugt ME
Acceptance and commitment therapy (ACT), as an empirically based third-wave cognitive behavioral therapy, has shown promise in enhancing well-being and functioning across diverse populations. However, in the context of caregiving, the effect size of available ACT interventions remains at best moderate, sometimes accompanied by high dropout rates, highlighting the need for more effective and feasible intervention designs.
Accumulative Assessment of Upper Extremity
Lin GH, Lee SC, Huang CY, Wang I, Lee YC, Hsueh IP and Hsieh CL
The Fugl-Meyer assessment for upper extremity (FMA-UE) is a measure for assessing upper extremity motor function in patients with stroke. However, the considerable administration time of the assessment decreases its feasibility. This study aimed to develop an accumulative assessment system of upper extremity motor function (AAS-UE) based on the FMA-UE to improve administrative efficiency while retaining sufficient psychometric properties.
Study protocol: randomized controlled trial of an individualized music intervention for people with dementia in the home care setting
Jakob E, Meininger J, Hillebrand M, Weise L and Wilz G
Studies suggest that individualized music listening is an effective, non-pharmacological intervention for improving the quality of life of people with dementia in the institutional care setting. Noting that most people with dementia live at home, we conduct a randomized controlled trial to assess the feasibility and effectiveness of an app-based individualized music listening intervention for people with dementia in the home care setting. The intervention is delivered by family caregivers.
Yoga-Based Interventions in Low-Income Populations: A Scoping Review
Nagaswami MV, Saper RB, Streeter CC, Uebelacker L, Ding G, Dalvie A, Norton R, Mischoulon D and Nyer MB
The popularity of yoga has surged in recent years; however, yoga practitioners have remained a largely homogenous population. Research reflects that most practitioners are of a higher socioeconomic status. There are access barriers to yoga for lower income individuals, likely due to factors such as financial constraints and logistical challenges. The primary goal of this review was to synthesize literature on yoga research among low-income populations and better understand the feasibility and acceptability of such interventions. A secondary goal was to assess the consistency of metrics for reporting feasibility and acceptability across such studies using the CheckList Standardizing the Reporting of Interventions for Yoga (CLARIFY) guidelines as a framework. Third, the authors sought to propose additional standardized CLARIFY guidelines that may enhance reporting on the diversity of yoga research populations, adherence, and retention. The electronic databases PubMed, PsycINFO, Cochrane Central Register of Controlled Trials, and Google Scholar were searched in May 2022 using a prespecified search string. Articles assessing a yoga intervention in predominantly low-income adult populations were deemed eligible for inclusion. The search resulted in 512 potential articles. Eleven were deemed eligible for inclusion. The included studies reported mostly positive effects of yoga on the target outcome (i.e., pain/disability, quality of life/wellness, and psychiatric symptoms). Recruitment and retention data showed generally good attendance and high study completion rates. Common study design components included recruitment embedded within preexisting medical settings, proximal yoga locations, and mitigation of yoga-related costs. Finally, the authors noted inconsistency in the reporting of adherence, retention, and other sociodemographic characteristics of participants and yoga instructors (e.g., race, ethnicity, and income). Yoga may promote physical and mental health for low-income individuals. Important facilitators to access are noted, such as proximal study settings, as well as barriers such as the need for childcare that can be addressed in future research. In addition, several study design considerations could help address the specific needs of low-income participants in yoga research, such as compensating participants, recruiting within existing medical settings, and providing yoga-related equipment at no cost. Finally, the authors suggest specific ways to enhance reporting of study metrics related to socioeconomic diversity, by adding to the preexisting CLARIFY guidelines.
Suspected Simple Appendicitis in Children: Should We Use a Nonoperative, Antibiotic-Free Approach? An Observational Study
Reis Wolfertstetter P, Ebert JB, Barop J, Denzinger M, Kertai M, Schlitt HJ and Knorr C
Simple appendicitis may be self-limiting or require antibiotic treatment or appendectomy. The aim of this study was to assess the feasibility and safety of a nonoperative, antibiotic-free approach for suspected simple appendicitis in children.
Network medicine informed multi-omics integration identifies drug targets and repurposable medicines for Amyotrophic Lateral Sclerosis
Yu M, Xu J, Dutta R, Trapp B, Pieper AA and Cheng F
Amyotrophic Lateral Sclerosis (ALS) is a devastating, immensely complex neurodegenerative disease by lack of effective treatments. To date, the challenge to establishing effective treatment for ALS remains formidable, partly due to inadequate translation of existing human genetic findings into actionable ALS-specific pathobiology for subsequent therapeutic development. This study evaluates the feasibility of network medicine methodology via integrating human brain-specific multi-omics data to prioritize drug targets and repurposable treatments for ALS. Using human brain-specific genome-wide quantitative trait loci (x-QTLs) under a network-based deep learning framework, we identified 105 putative ALS-associated genes enriched in various known ALS pathobiological pathways, including regulation of T cell activation, monocyte differentiation, and lymphocyte proliferation. Specifically, we leveraged non-coding ALS loci effects from genome-wide associated studies (GWAS) on brain-specific expression quantitative trait loci (QTL) (eQTL), protein QTLs (pQTL), splicing QTL (sQTL), methylation QTL (meQTL), and histone acetylation QTL (haQTL). Applying network proximity analysis of predicted ALS-associated gene-coding targets and existing drug-target networks under the human protein-protein interactome (PPI) model, we identified a set of potential repurposable drugs (including Diazoxide, Gefitinib, Paliperidone, and Dimethyltryptamine) for ALS. Subsequent validation established preclinical and clinical evidence for top-prioritized repurposable drugs. In summary, we presented a network-based multi-omics framework to identify potential drug targets and repurposable treatments for ALS and other neurodegenerative disease if broadly applied.
[Video-Assisted Psychotherapy For Refugees: A Pilot Study]
Schneider J, Wiechers M, Burger M, Pogarell O, Übleis A, Padberg F and Strupf M
Global conflicts and humanitarian crises led to an increase in forced migration to Germany in recent years. To improve the mental health care system for refugees and asylum seekers in Germany perspectively, we aim to examine the feasibility of implementing the culturally sensitive group psychotherapy Empowerment for refugees with affective disorders in a video-assisted setting.
An imagery rescripting based intervention in children and adolescents who endured a negative life event: A pilot study, satisfaction and feasibility survey
Simon E, Beeftink J, van 't Hullenaar B and van Hooren S
ImRs, a technique targeting distressing mental images, has shown promise in adult psychiatric treatment. Initial research indicates positive outcomes in children, with potential for reducing mental health care burden. This pilot study examined the use of Imagery Rescripting (ImRs) as an intervention for children who have experienced negative life events. We aimed to assess short-term emotional changes, participant satisfaction, and the feasibility of a larger-scale ImRs intervention for children.
Exploring Brain and Heart Interactions during Electroconvulsive Therapy with Point-of-Care Ultrasound
Chang MG, Barbour TA and Bittner EA
Electroconvulsive therapy (ECT) is a procedure commonly used to treat a number of severe psychiatric disorders, including pharmacologic refractory depression, mania, and catatonia by purposefully inducing a generalized seizure that results in significant hemodynamic changes as a result of an initial transient parasympathetic response that is followed by a marked sympathetic response from a surge in catecholamine release. While the physiologic response of ECT on classic hemodynamic parameters such as heart rate and blood pressure has been described in the literature, real-time visualization of cardiac function using point-of-care ultrasound (POCUS) during ECT has never been reported. This study utilizes POCUS to examine cardiac function in two patients with different ages and cardiovascular risk profiles undergoing ECT.
Monochrome Multiplex Quantitative PCR Telomere Length Measurement
Martin NA, McLester-Davis LWY, Roy TR, Magruder MG, Hastings WJ and Drury SS
Telomeres are ribonucleoprotein structures at the end of all eukaryotic chromosomes that protect DNA from damage and preserve chromosome stability. Telomere length (TL) has been associated with various exposures, biological processes, and health outcomes. This article describes the monochrome multiplex quantitative polymerase chain reaction (MMqPCR) assay protocol routinely conducted in our laboratory for measuring relative mean TL from human DNA. There are several different PCR-based TL measurement methods, but the specific protocol for the MMqPCR method presented in this publication is repeatable, efficient, cost-effective, and suitable for population-based studies. This detailed protocol outlines all information necessary for investigators to establish this assay in their laboratory. In addition, this protocol provides specific steps to increase the reproducibility of TL measurement by this assay, defined by the intraclass correlation coefficient (ICC) across repeated measurements of the same sample. The ICC is a critical factor in evaluating expected power for a specific study population; as such, reporting cohort-specific ICCs for any TL assay is a necessary step to enhance the overall rigor of population-based studies of TL. Example results utilizing DNA samples extracted from peripheral blood mononuclear cells demonstrate the feasibility of generating highly repeatable TL data using this MMqPCR protocol.
Service User Representation in Qualitative Research on Cognitive Health and Related Interventions for Psychosis: A Scoping Review
Gonzales L and Jones N
Cognitive health in schizophrenia spectrum psychosis has received substantial empirical attention in recent decades, coinciding with the development and implementation of interventions including cognitive remediation. Subjective experience in psychosis, including qualitative explorations of service user perspectives, has also proliferated; however, there is no available synthesis of service user representation in the psychosis cognitive health literature. This scoping review investigated prevalence and characteristics of qualitative research reporting service user perspectives across the extant research on cognitive health and related interventions in psychosis.
Left prefrontal intermittent theta burst stimulation ameliorates tinnitus distress and symptoms of depression - A feasibility study
Hebel T, Schecklmann M, Abdelnaim MA, Weber FC, Langguth B and Schoisswohl S
Tinnitus remains a notoriously difficult to treat clinical entity. 1-2% of the entire population report relevant emotional distress due to tinnitus, and causal treatments are lacking. Repetitive transcranial magnetic stimulation (rTMS), most commonly of auditory cortical areas, has shown mixed results in the past. Prefrontal rTMS, including intermittent theta burst stimulation (iTBS) has shown more promising results in the treatment of depression, and clinical data suggests a meaningful overlap between tinnitus and depression. Therefore, we performed a feasibility study of 28 consecutive patients with tinnitus treated with an iTBS protocol over the left dorsolateral prefrontal cortex for three weeks. After treatment, we observed significant ameliorations of tinnitus distress as measured by the Tinnitus Handicap Inventory Questionnaire (THI), the Tinnitus Functional Index (TFI), the Mini-Tinnitus Questionnaire (Mini-TQ) and also of depression as measured by the Major Depression Inventory (MDI). Effect sizes were small to moderate and short-lived. Treatment response rates, defined as improvement of the THI of at least 7 points, were 35.7%. At follow-up twelve weeks after end of treatment, severity of tinnitus and depression returned to approximately baseline level on a descriptive level. Amelioration of depressive symptoms correlated only with TFI change, but not that of other measures of tinnitus distress. The data suggest that a prefrontal iTBS protocol might be applied in the treatment of tinnitus and open avenues for future neurostimulatory treatments other than those of auditory regions.
Comparison of transdermal alcohol concentration and self-reported alcohol consumption in people with alcohol dependence attending community alcohol treatment services
Brobbin E, Deluca P, Coulton S, Parkin S and Drummond C
We aimed to assess the accuracy and wearability of a transdermal alcohol sensor (TAS) (BACtrack Skyn) with people currently receiving treatment at alcohol services.
Neuroimmune modulators as novel pharmacotherapies for substance use disorders
Grodin EN
One promising avenue of research is the use of neuroimmune modulators to treat substance use disorders (SUDs). Neuroimmune modulators target the interactions between the nervous system and immune system, which have been found to play a crucial role in the development and maintenance of SUDs. Multiple classes of substances produce alterations to neuroimmune signaling and peripheral immune function, including alcohol, opioids, and psychostimulants Preclinical studies have shown that neuroimmune modulators can reduce drug-seeking behavior and prevent relapse in animal models of SUDs. Additionally, early-phase clinical trials have demonstrated the safety and feasibility of using neuroimmune modulators as a treatment for SUDs in humans. These therapeutics can be used as stand-alone treatments or as adjunctive. This review summarizes the current state of the field and provides future directions with a specific focus on personalized medicine.
rTMS for post-covid-19 condition: A sham-controlled case series involving iTBS-300 and iTBS-600
Sakib MN, Saragadam A, Santagata MC, Jolicoeur-Becotte M, Kozyr L, Burhan AM and Hall PA
Post-Covid-19 Condition (PCC) is a syndrome comprised of symptoms persisting 3 months or more beyond SARS-CoV-2 primary infection. It is typically characterized by fatigue, cognitive problems and psychiatric symptoms, as well as cardiac symptoms that contribute to exercise intolerance in many. Despite the high prevalence of PCC among those with a prior SARS-CoV-2 infection, there is currently no widely accepted rehabilitation strategy, and many conventional modalities are movement-based. Non-invasive brain stimulation methods such as repetitive transcranial magnetic stimulation (rTMS) may have some potential to alleviate the cognitive and affective symptoms of PCC without reliance on exercise. The purpose of the present study was to explore the feasibility and tolerability of using rTMS to treat symptoms of "brain fog" and affective disturbance among those living with PCC, using a case series design. We enrolled four individuals with PCC following a confirmed SARS-CoV-2 infection, at least 3 months after the resolution of the primary infection. Participants were randomized to 4 sessions of active and 2 sessions of sham intermittent theta-burst stimulation (iTBS); two intensities of iTBS were evaluated: iTBS-300 and iTBS-600. No adverse events occurred in active or sham stimulation; 2 participants reported tingling sensation on the scalp but no other tolerability issues. Trends in symptoms suggested improvements in cognitive interference, quality of life, and anxiety in the majority of participants. In summary, in this case series iTBS was well tolerated among 4 individuals with PCC; active stimulation was associated with positive trends in some primary symptom clusters as compared with sham stimulation. Future studies should examine the effects of iTBS on PCC symptoms in the context of experimental studies and randomized controlled trials.
Effect of drama training on self-esteem and personality strengths: A feasibility case control study of nidotherapy
Mansell C, Yang M and Tyrer P
Although there are many case reports and qualitative studies on the likely positive effects of drama on mental health there have been few quantitative studies with mentally ill patients.
Evaluating a rehabilitative intervention for substance-dependent patients with and without their accompanying children in Germany (KontextSucht): study protocol for a non-randomised trial
Stullich A, Hoffmann L, Stephan J, Gehrmann J, Richter M and
People suffering from substance use disorders often live in social contexts with children or are parents themselves. Addicted parents show specific substance-related problems while raising their children, which often leads to various lifelong consequences for the children. The German rehabilitative treatment system allows bringing children to inpatient treatment centres. This mixed-methods study evaluates a newly developed intervention, called 'KontextSucht' or 'AddictionContext', for parents in rehabilitation treatment centres concerning the effectiveness of the intervention in parenting and abstinence outcome.
Implementing patient-reported outcome measures on an adolescent inpatient psychiatry unit: A feasibility study
Waitz C, Caracansi A, Kaufman K, Campbell E, Anglemyer E, Anglero-Diaz Y, Paden S, Zou B and Ibeziako P
This article examines the feasibility of implementing patient-reported outcome (PRO) measures with adolescents on an inpatient psychiatry service. During the study period (March 8, 2021, to June 7, 2022), a total of 154 patient encounters were recorded for adolescents between 12 and 17 years of age. PROs were piloted during the first 3 months of the study period, with a focus on technical implementation. In the 12 months from June 8, 2021, through June 7, 2022, the PRO project moved to full implementation across all patient encounters. Fisher's exact test and independent t tests were conducted to examine the differences between patients who completed the PROs and patients who did not complete them to determine the representativeness of the sample receiving them. During the 3-month pilot period, 31.8% of patients completed the PROs at admission and discharge, while during the 12-month full implementation, 74.5% of patients completed them at both time points. Statistical tests showed no significant diagnostic, sex, or race/ethnicity differences between patients who received and did not receive the outcome measures. Even without funding, small inpatient psychiatry services for adolescents can feasibly implement PROs with completion rates similar to other published studies and capture the majority of the patients served. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
Feasibility of precision smoking treatment in a low-income community setting: results of a pilot randomized controlled trial in The Southern Community Cohort Study
Lee SS, Senft Everson N, Sanderson M, Selove R, Blot WJ, King S, Gilliam K, Kundu S, Steinwandel M, Sternlieb SJ, Cai Q, Warren Andersen S, Friedman DL, Connors Kelly E, Fadden MK, Freiberg MS, Wells QS, Canedo J, Tyndale RF, Young RP, Hopkins RJ and Tindle HA
The feasibility of precision smoking treatment in socioeconomically disadvantaged communities has not been studied.
Improving Health Professional Recognition and Response to Child Maltreatment and Intimate Partner Violence: Protocol for Two Mixed Methods Pilot Randomized Controlled Trials
Kimber M, Baker-Sullivan E, Stewart DE and Vanstone M
The optimal educational approach for preparing health professionals with the knowledge and skills to effectively recognize and respond to family violence, including child maltreatment and intimate partner violence, remains unclear. The Violence, Evidence, Guidance, and Action (VEGA) Family Violence Education Resources is a novel intervention that can be completed via self-directed learning or in a workshop format; both approaches focus on improving health professional preparedness to address family violence.
A feasibility, randomised controlled trial of Club Connect: a group-based healthy brain ageing cognitive training program for older adults with major depression within an older people's mental health service
Woolf C, Kaplan L, Norrie LM, Burke D, Cunich M, Mowszowski L and Naismith SL
Using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework, we outline steps taken to implement an evidence-based cognitive training program, Club Connect, in older adults with major depressive disorder in an Older People's Mental Health Service in Sydney, Australia. The primary aim was to explore feasibility (or 'reach'), tolerability (or 'implementation'), and acceptability (or 'adoption'). The secondary aim was to explore the most sensitive clinical outcomes and measurement tools (i.e. 'effectiveness') to inform a formal randomised controlled trial, and to explore the healthcare resources used (i.e. costs) to assist decision-making by health care managers and policy-makers in relation to future resource allocation.
Mind-Body Interventions for Youth with Chronic Medical Conditions: A Scoping Review of the Literature
Srinivasan R, McVoy M, Neudecker M, Divan MK, Wu A, Cascio ME, Dusek JA and Miller DW
Little is known about the applicability, utilization, and effectiveness of mind-body interventions (MBIs) for conditions that are not predominantly pain, neoplastic, or psychiatric, particularly in pediatric patients. This scoping review describes research pertaining to such interventions in youth with nonpain, noncancer, and nonpsychiatric predominant chronic medical conditions. Searches of EBSCO CINAHL, Elsevier Scopus, Ovid for MEDLINE, and Ovid PsycInfo were conducted to investigate MBIs in youth under 18 years of age with nonpain, noncancer, and nonpsychiatric predominant chronic medical conditions. Articles published between 2010 and 2020 were included. Abstracts were screened by three authors for inclusion, and disagreements were resolved by a designated author. Selected full-text articles were divided among all authors for review of study quality, intervention feasibility and acceptability, and effectiveness. The search yielded 1010 titles with 15 meeting the final inclusion criteria, studying a total of 641 youth. Participants ranged in age from 6 to 19 years (included studies had data on participants <18 years reported separately); 61.5% were female ( = 394) and 38.5% were male ( = 247). The two most common conditions studied were asthma and irritable bowel syndrome, with yoga being the most popular intervention. Overall, MBIs showed promising preliminary evidence for improving symptoms and quality of life in youth with chronic medical conditions. MBIs have been successfully delivered and show promise in symptom palliation and quality of life improvement for youth with a variety of chronic medical conditions. More data from high-quality randomized controlled trials are needed to further characterize the effectiveness of specific modalities for specific conditions.
Resilience strengthening in youth with a chronic medical condition: a randomized controlled feasibility trial of a combined app and coaching program
Bischops AC, Sieper L, Dukart J, Schaal NK, Reinauer C, Oommen PT, Tomoiaga C, David O, Mayatepek E and Meissner T
Youth with a chronic medical condition (CMC) are often affected by comorbid mental disorders. Resilience-strengthening interventions can protect youth's mental health, yet evidence-based programs remain scarce. To address this lack, this study aimed to evaluate the feasibility of a dual approach combining app-based resilience training and cognitive behavioral group coaching. Fifty-one youths with CMC treated at a German university children's hospital aged 12-16 years were recruited. They were randomly assigned to a combined app game and coaching intervention or sole app gameplay. At pre-, post-intervention, and at a 2-month follow-up resilience, automatic negative thoughts and an app and coaching evaluation were assessed. Feasibility was defined as a recruitment rate of 70%, an 85% adherence rate for the REThink game, and 70% participation in both coaching sessions. Feasibility criteria were reached for coaching participation but not for recruitment or app adherence. While both the REThink game app and coaching intervention had high acceptance rates among youth with CMC, participants receiving additional coaching sessions showed higher satisfaction and adherence rates. Participants preferred remote to in-person meetings. The findings support a combination of a gamification app approach with online group coaching. Group coaching can improve adherence while online options increase accessibility. Future research should focus on testing in diverse participant samples, language, and age-adapted updates of the REThink game app. These findings provide guidance for increasing adherence in future intervention studies in youth with CMC cohorts.
Feasibility and acceptability of a virtual mindfulness intervention for Black adults with PTSD and depression: Randomized controlled trial
Powers A, Lathan EC, McAfee E, Mekawi Y, Dixon HD, Lopez E, Ali S, Hinrichs R, Bradley B, Carter S and Kaslow NJ
Mindfulness-based cognitive therapy (MBCT) offers promise as a group-based intervention to alleviate posttraumatic stress disorder (PTSD) and depression symptoms in traumatized Black adults. Given the high level of barriers that exist for low-income Black adults, virtual delivery of MBCT may be helpful. This pilot randomized controlled trial assessed feasibility and acceptability of an adapted 8-week virtual MBCT group intervention for Black adults screening positive for PTSD and depression. Forty-six participants (89.3% women) recruited from an urban safety net hospital were randomized to MBCT or waitlist control (WLC). Overall feasibility was fair (70%); however, completion rates were higher for WLC than MBCT (90% vs. 54%). Group acceptability was high across quantitative and qualitative measures for study completers. Perceived barriers to psychological treatment were high (>9). While showing potential via improved coping skills and positive health changes, this intervention's success hinges on mitigating engagement barriers for future delivery; additional studies are warranted.
Digital health interventions for suicide prevention among LGBTQ: A narrative review
Paudel K, Gautam K, Bhandari P, Shah S, Wickersham JA, Acharya B, Sapkota S, Adhikari SK, Baral PP, Shrestha A and Shrestha R
Suicidal thoughts and behaviors (STBs) are prevalent within the Lesbian, Gay, Bisexual, Transgender, and Queers (LGBTQ) community, often exacerbated by challenges in accessing care and the perceived stigma and discrimination tied to disclosing one's identity. Digital health interventions that offer psychosocial self-help present a promising platform to reach individuals at risk of STBs, especially those who may not engage with conventional health services. This review aimed to assess the role of digital-based intervention in reducing STBs among LGBTQ individuals.
Modeling brain network flexibility in networks of coupled oscillators: a feasibility study
Chinichian N, Lindner M, Yanchuk S, Schwalger T, Schöll E and Berner R
Modeling the functionality of the human brain is a major goal in neuroscience for which many powerful methodologies have been developed over the last decade. The impact of working memory and the associated brain regions on the brain dynamics is of particular interest due to their connection with many functions and malfunctions in the brain. In this context, the concept of brain flexibility has been developed for the characterization of brain functionality. We discuss emergence of brain flexibility that is commonly measured by the identification of changes in the cluster structure of co-active brain regions. We provide evidence that brain flexibility can be modeled by a system of coupled FitzHugh-Nagumo oscillators where the network structure is obtained from human brain Diffusion Tensor Imaging (DTI). Additionally, we propose a straightforward and computationally efficient alternative macroscopic measure, which is derived from the Pearson distance of functional brain matrices. This metric exhibits similarities to the established patterns of brain template flexibility that have been observed in prior investigations. Furthermore, we explore the significance of the brain's network structure and the strength of connections between network nodes or brain regions associated with working memory in the observation of patterns in networks flexibility. This work enriches our understanding of the interplay between the structure and function of dynamic brain networks and proposes a modeling strategy to study brain flexibility.
Supporting physical activity through co-production in people with severe mental ill health (SPACES): protocol for a randomised controlled feasibility trial
Jones G, Bailey L, Beeken RJ, Brady S, Cooper C, Copeland RJ, Crosland S, Dawson S, Faires M, Gilbody S, Haynes H, Hill A, Hillison E, Horspool M, Lee E, Li J, Machaczek KK, Parrott S, Quirk H, Stubbs B, Tew GA, Traviss-Turner G, Turton E, Walker L, Walters S, Weich S, Wildbore E and Peckham E
Severe mental ill health (SMI) includes schizophrenia, bipolar disorder and schizoaffective disorder and is associated with premature deaths when compared to people without SMI. Over 70% of those deaths are attributed to preventable health conditions, which have the potential to be positively affected by the adoption of healthy behaviours, such as physical activity. People with SMI are generally less active than those without and face unique barriers to being physically active. Physical activity interventions for those with SMI demonstrate promise, however, there are important questions remaining about the potential feasibility and acceptability of a physical activity intervention embedded within existing NHS pathways.
HealthySMS Text Messaging System Adjunct to Adolescent Group Cognitive Behavioral Therapy in the Context of COVID-19 (Let's Text!): Pilot Feasibility and Acceptability Study
Haack LM, Armstrong CC, Travis K, Aguilera A and Darrow SM
The widespread occurrence and devastating impact of adolescent depression warrant health service research focused on feasible and acceptable digital health tools to supplement evidence-based intervention (EBI) efforts, particularly in the context of shelter-in-place guidelines disrupting youth socialization and service use in the wake of the COVID-19 pandemic. Given the promise of SMS text message interventions to enhance EBI engagement, our team developed the HealthySMS system as an adjunct to one of the most empirically supported interventions for adolescent depression: cognitive behavioral therapy (CBT) group services. The system sends daily SMS text messages requesting responses assessing mood, thoughts, and activities; weekly attendance reminder messages; daily tips about adherence (eg, a prompt for activity completion); and personalized responses based on participants' texts.
Work Engagement and Well-being Study (SWELL): a randomised controlled feasibility trial evaluating the effects of mindfulness versus light physical exercise at work
Vainre M, Dalgleish T, Watson P, Haag C, Dercon Q, Galante J and Hitchcock C
Mindfulness-based programmes (MBPs) are increasingly offered at work, often in online self-guided format. However, the evidence on MBPs' effect on work performance (WP) is inconsistent.
The Bergen 4-day treatment for social anxiety disorder: a pilot study
Hansen B, Eide TO, Reiråskag MA, Tjelle KA, Solem S and Hagen K
Few studies have examined the use of concentrated and intensified cognitive behaviour therapy for treating social anxiety disorder (SAD). The aim of this study was to examine the feasibility of the Bergen 4-Day Treatment (B4DT) for treating SAD.
The Virtual Hope Box mobile application: A systematic review of the literature
Gerner JL, Tucker RP, Moscardini EH, Bagge CL and Reger MA
The Virtual Hope Box (VHB) mobile application is an adapted version of the conventional hope box intervention that is used in several evidence-based treatments for suicide behaviors. The VHB is an award-winning app developed by a collaboration between the Departments of Defense and Veterans Affairs. Multiple studies have assessed the utility and effectiveness of the VHB for use in suicide prevention, but no reviews of the literature have been conducted.
The polymorphisms of candidate pharmacokinetic and pharmacodynamic genes and their pharmacogenetic impacts on the effectiveness of risperidone maintenance therapy among Saudi children with autism
Shilbayeh SAR, Adeen IS, Alhazmi AS, Aljurayb H, Altokhais RS, Alhowaish N, Aldilaijan KE, Kamal M and Alnakhli AM
Antipsychotics, including risperidone (RIS), are frequently indicated for various autism spectrum disorder (ASD) manifestations; however, "actionable" PGx testing in psychiatry regarding antipsychotic dosing and selection has limited applications in routine clinical practice because of the lack of standard guidelines, mostly due to the inconsistency and scarcity of genetic variant data. The current study is aimed at examining the association of RIS effectiveness, according to ABC-CV and CGI indexes, with relevant pharmacokinetics (PK) and pharmacodynamics (PD) genes.
Development and evaluation of a manualised mental health awareness and stigma reduction intervention for Black faith communities: study protocol for the ON TRAC feasibility study
Codjoe LN, Henderson C, N'Danga-Koroma J, Lempp H, Romeo R, Bakolis I and Thornicroft G
This paper presents the study protocol for a feasibility study of a manualised mental health awareness and stigma reduction intervention for Black faith communities, as part of the Outcomes and Needs of Traditional Religious And Complementary practitioners (ON TRAC) project. The primary objective is to assess the feasibility and acceptability of the intervention and the secondary objectives include assessment of the feasibility of: recruiting participants to take part in the intervention, delivering the intervention, and conducting qualitative assessments, and use of the selected scales. The findings from this study will be used to inform the development of a subsequent trial which will focus on exploring the potential impact of the intervention on stigma-related knowledge, attitudes, and behaviour.
An integrated primary care service to reduce cardiovascular disease risk in people with severe mental illness: Primrose-A - thematic analysis of its acceptability, feasibility, and implementation
Shaw P, Mifsud A, Osborn D, Nahata N, Hall C, Prenelle I and Lamb D
Cardiovascular disease among patients with severe mental illness in England is a major preventable contributor to premature mortality. To address this, a nurse and peer-coach delivered service (Primrose-A) was implemented in three London general practices from 2019 (implementation continued during COVID-19). This study aimed to conduct interviews with patient and staff to determine the acceptability of, and experiences with, Primrose-A.
Personalized mood prediction from patterns of behavior collected with smartphones
Balliu B, Douglas C, Seok D, Shenhav L, Wu Y, Chatzopoulou D, Kaiser W, Chen V, Kim J, Deverasetty S, Arnaudova I, Gibbons R, Congdon E, Craske MG, Freimer N, Halperin E, Sankararaman S and Flint J
Over the last ten years, there has been considerable progress in using digital behavioral phenotypes, captured passively and continuously from smartphones and wearable devices, to infer depressive mood. However, most digital phenotype studies suffer from poor replicability, often fail to detect clinically relevant events, and use measures of depression that are not validated or suitable for collecting large and longitudinal data. Here, we report high-quality longitudinal validated assessments of depressive mood from computerized adaptive testing paired with continuous digital assessments of behavior from smartphone sensors for up to 40 weeks on 183 individuals experiencing mild to severe symptoms of depression. We apply a combination of cubic spline interpolation and idiographic models to generate individualized predictions of future mood from the digital behavioral phenotypes, achieving high prediction accuracy of depression severity up to three weeks in advance (R ≥ 80%) and a 65.7% reduction in the prediction error over a baseline model which predicts future mood based on past depression severity alone. Finally, our study verified the feasibility of obtaining high-quality longitudinal assessments of mood from a clinical population and predicting symptom severity weeks in advance using passively collected digital behavioral data. Our results indicate the possibility of expanding the repertoire of patient-specific behavioral measures to enable future psychiatric research.
A pilot study to investigate the safety and feasibility of antiretroviral therapy for Alzheimer's disease (ART-AD)
Sullivan AC, Zuniga G, Ramirez P, Fernandez R, Wang CP, Li J, Davila L, Pelton K, Gomez S, Sohn C, Gonzalez E, Lopez-Cruzan M, Gonzalez DA, Parker A, Zilli E, de Erausquin GA, Seshadri S, Espinoza S, Musi N and Frost B
Retrotransposons are viral-like DNA sequences that constitute approximately 41% of the human genome. Studies in mice, cultured cells, and human brain indicate that retrotransposons are activated in settings of tauopathy, including Alzheimer's disease, and causally drive neurodegeneration. The anti-retroviral medication 3TC (lamivudine), a nucleoside analog reverse transcriptase inhibitor, limits retrotransposon activation and suppresses neurodegeneration in tau transgenic two mouse models of tauopathy, and in brain assembloids derived from patients with sporadic Alzheimer's disease. We performed a 24-week phase 2a open-label clinical trial of 300 mg daily oral 3TC (NCT04552795) in 12 participants aged 52-83 years with a diagnosis of mild cognitive impairment due to suspected Alzheimer's disease. Primary outcomes included feasibility, blood brain barrier penetration, effects of 3TC on reverse transcriptase activity in the periphery, and safety. Secondary outcomes included changes in cognition and fluid-based biomarkers of neurodegeneration and neuroinflammation. All participants completed the six-month trial; one event of gastrointestinal bleeding due to a peptic ulcer was reported. 3TC was detected in blood and cerebrospinal fluid (CSF) of all participants, suggestive of adherence to study drug and effective brain penetration. Cognitive measures remained stable throughout the study. Glial fibrillary acidic protein (GFAP) (=0.03) and Flt1 (=0.05) were significantly reduced in CSF over the treatment period; Aβ42/40 (=0.009) and IL-15 (=0.006) were significantly elevated in plasma. While this is an open label study of small sample size, the significant decrease of some neurodegeneration- and neuroinflammation-related biomarkers in CSF, significantly elevated levels of plasma Aβ42/40, and a trending decrease of CSF NfL after six months of 3TC exposure suggest a beneficial effect on subjects with mild cognitive impairment due to suspected Alzheimer's disease. Feasibility, safety, tolerability, and central nervous system (CNS) penetration assessments further support clinical evaluation of 3TC in a larger placebo-controlled, multi-dose clinical trial.
Developing interventions to improve detection of depression in primary healthcare settings in rural Ethiopia
Demissie M, Birhane R, Hanlon C, Eshetu T, Medhin G, Minaye A, Habtamu K, Cleare AJ, Milkias B, Prince M and Fekadu A
The poor detection of depression in primary healthcare (PHC) in low- and middle-income countries continues to threaten the plan to scale up mental healthcare coverage.
Reliability of Telepsychiatry Assessments Using the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV for Children With Neurodevelopmental Disorders and Their Caregivers: Randomized Feasibility Study
Kurokawa S, Nomura K, Hosogane N, Nagasawa T, Kawade Y, Matsumoto Y, Morinaga S, Kaise Y, Higuchi A, Goto A, Inada N, Kodaira M and Kishimoto T
Given the global shortage of child psychiatrists and barriers to specialized care, remote assessment is a promising alternative for diagnosing and managing attention-deficit/hyperactivity disorder (ADHD). However, only a few studies have validated the accuracy and acceptability of these remote methods.
Internet- and mobile-based psychological interventions for post-traumatic stress symptoms in youth: a systematic review and meta-analysis
Schulte C, Harrer M, Sachser C, Weiss J and Zarski AC
Psychological interventions can help reduce posttraumatic stress symptoms (PTSS) in youth, but many do not seek help. Internet- and mobile-based interventions (IMIs) show promise in expanding treatment options. However, the overall evidence on IMIs in reducing PTSS among youth remains unclear. This systematic review and meta-analysis investigated the efficacy of IMIs in PTSS reduction for youth exposed to traumatic events. A comprehensive literature search was conducted in January 2023 including non-randomized and randomized-controlled trials (RCT) investigating the effects of IMIs on PTSS in youth aged ≤25 years. Six studies were identified with five providing data for the meta-analysis. The majority of studies included youth with different types of trauma irrespective of PTSS severity at baseline (k = 5). We found a small within-group effect in reducing PTSS from baseline to post-treatment (g = -0.39, 95% CrI: -0.67 to -0.11, k = 5; n = 558; 9 comparisons). No effect emerged when comparing the effect of IMIs to control conditions (g = 0.04; 95%-CrI: -0.52 to 0.6, k = 3; n = 768; k = 3; 4 comparisons). Heterogeneity was low between and within studies. All studies showed at least some concerns in terms of risk of bias. Current evidence does not conclusively support the overall efficacy of IMIs in addressing youth PTSS. This review revealed a scarcity of studies investigating IMIs for youth exposed to traumatic events, with most being feasibility studies rather than adequately powered RCTs and lacking a trauma focus. This underscores the demand for more high-quality research.
Mobile applications in adolescent psychotherapy during the COVID-19 pandemic: a systematic review
Wüllner S, Hermenau K, Krutkova M, Petras IK, Hecker T and Siniatchkin M
To bridge the gap in adolescent psychotherapy created by the increasing need for mental health interventions and the limited possibilities of in-person treatment during the pandemic, many health care providers opted to offer online mental health care programs. As a result, the number of mental health apps available in app stores experienced a sharp increase during the COVID-19 pandemic.
H and P magnetic resonance spectroscopy reveals potential pathogenic and biomarker metabolite alterations in Lafora disease
Chan KL, Panatpur A, Messahel S, Dahshi H, Johnson T, Henning A, Ren J and Minassian BA
Lafora disease is a fatal teenage-onset progressive myoclonus epilepsy and neurodegenerative disease associated with polyglucosan bodies. Polyglucosans are long-branched and as a result precipitation- and aggregation-prone glycogen. In mouse models, downregulation of glycogen synthase, the enzyme that elongates glycogen branches, prevents polyglucosan formation and rescues Lafora disease. Mouse work, however, has not yet revealed the mechanisms of polyglucosan generation, and few human studies have been performed. Here, non-invasive magnetic resonance spectroscopy (H and P) was applied to test scan feasibility and assess neurotransmitter balance and energy metabolism in Lafora disease towards a better understanding of pathogenesis. Macromolecule-suppressed gamma-aminobutyric acid (GABA)-edited H magnetic resonance spectroscopy and P magnetic resonance spectroscopy at 3 and 7 tesla, respectively, were performed in 4 Lafora disease patients and a total of 21 healthy controls (12 for the H magnetic resonance spectroscopy and 9 for the PMRS). Spectra were processed using in-house software and fit to extract metabolite concentrations. From the H spectra, we found 33% lower GABA concentrations ( = 0.013), 34% higher glutamate + glutamine concentrations ( = 0.011) and 24% lower -acetylaspartate concentrations ( = 0.0043) in Lafora disease patients compared with controls. From the P spectra, we found 34% higher phosphoethanolamine concentrations ( = 0.016), 23% lower nicotinamide adenine dinucleotide concentrations ( = 0.003), 50% higher uridine diphosphate glucose concentrations ( = 0.004) and 225% higher glucose 6-phosphate concentrations in Lafora disease patients versus controls ( = 0.004). Uridine diphosphate glucose is the substrate of glycogen synthase, and glucose 6-phosphate is its extremely potent allosteric activator. The observed elevated uridine diphosphate glucose and glucose 6-phosphate levels are expected to hyperactivate glycogen synthase and may underlie the generation of polyglucosans in Lafora disease. The increased glutamate + glutamine and reduced GABA indicate altered neurotransmission and energy metabolism, which may contribute to the disease's intractable epilepsy. These results suggest a possible basis of polyglucosan formation and potential contributions to the epilepsy of Lafora disease. If confirmed in larger human and animal model studies, measurements of the dysregulated metabolites by magnetic resonance spectroscopy could be developed into non-invasive biomarkers for clinical trials.
A qualitative evaluation of the use of Problem Management Plus (PM+) among Arabic-speaking migrants with psychological distress in France - The APEX study
Surkan PJ, Rayes D, Bertuzzi L, Figueiredo N, Melchior M and Tortelli A
Feasibility studies with non-French speaking migrants in France are needed to inform appropriate adaptation of psychosocial intervention procedures. To test the WHO Problem Management Plus (PM+) intervention protocol for Arabic-speaking migrants in the Paris metropolitan region. Between 2019 and 2021 we recruited participants from three accommodation centres receiving asylum seekers or migrants experiencing social and economic difficulties. Participants experiencing psychological distress underwent five PM + sessions with trained helpers. Feasibility was evaluated through 15 interviews with 8 participants, 4 helpers, and 3 study supervisors. Interview topics covered PM + implementation in general and for each component. We also sought to understand problems with delivery and gathered suggestions for improvement. Data were analysed thematically using a deductive approach. We found implementation of PM + to be feasible, with predominantly positive reactions from participants, helpers and study staff. All intervention components were considered beneficial, with breathing exercises considered easy to implement and often sustained. Selection of problems and strategies to address them were described as challenging to execute. Psychosocial support from and rapport with helpers and the use of the native language were considered key strengths of the programme. However, we observed the need for complementary or higher intensity psychological support in some cases. Findings also highlighted the importance of addressing distress among non-specialist helpers delivering PM + . Finally, local guidance to social resources were suggested to be added in the protocol. PM + was well-liked and feasible, with cultural adjustments and increased access to community resources for migrants needed.
Treating depression at home with transcranial direct current stimulation: a feasibility study
Dragon K, Abdelnaim MA, Weber FC, Heuschert M, Englert L, Langguth B, Hebel T and Schecklmann M
Treating major depressive disorder (MDD) with transcranial direct current stimulation (tDCS) devices at home has various logistic advantages compared to tDCS treatment in the clinic. However, preliminary (controlled) studies showed side effects such as skin lesions and difficulties in the implementation of home-based tDCS. Thus, more data are needed regarding the feasibility and possible disadvantages of home-based tDCS.
Posttraumatic stress disorder in people with dementia: study protocol
Ruisch JE, Havermans DCD, Gielkens EMJ, Olff M, Daamen MAMJ, van Alphen SPJ, van Kordenoordt M, Schols JMGA, Schruers KRJ and Sobczak S
Posttraumatic stress disorder (PTSD) is considered an independent risk factor for dementia. Despite the (clinical) evidence that PTSD is associated with neuropsychiatric symptoms in people with dementia, studies on its prevalence and clinical manifestation are limited, and their quality is affected by the lack of a structured method to diagnose PTSD in this population. The primary aim of the current study is to validate the 'TRAuma and DEmentia' interview as a diagnostic tool for PTSD in people with dementia and to test feasibility of EMDR treatment for people with PTSD and dementia. This prospective multi-centre study is divided into two parts. In study A, 90 participants with dementia will be included to test the criterion validity, inter-rater reliability and feasibility of the 'TRAuma and DEmentia' interview. In study B, 29 participants with dementia and PTSD will receive eye movement desensitisation and reprocessing therapy by a trained psychologist, and 29 participants with dementia and PTSD will be placed on the waiting list control group. This study aims to improve the diagnostic process of PTSD and to assess the effects of eye movement desensitisation and reprocessing treatment in people with dementia living in Dutch care facilities. NL70479.068.20 / METC 20-063 / OSF registration: https://doi.org/10.17605/OSF.IO/AKW4F.
Feasibility and usability of remote monitoring in Alzheimer's disease
Muurling M, de Boer C, Hinds C, Atreya A, Doherty A, Alepopoulos V, Curcic J, Brem AK, Conde P, Kuruppu S, Morató X, Saletti V, Galluzzi S, Vilarino Luis E, Cardoso S, Stukelj T, Kramberger MG, Roik D, Koychev I, Hopøy AC, Schwertner E, Gkioka M, Aarsland D, Visser PJ and
Remote monitoring technologies (RMTs) can measure cognitive and functional decline objectively at-home, and offer opportunities to measure passively and continuously, possibly improving sensitivity and reducing participant burden in clinical trials. However, there is skepticism that age and cognitive or functional impairment may render participants unable or unwilling to comply with complex RMT protocols. We therefore assessed the feasibility and usability of a complex RMT protocol in all syndromic stages of Alzheimer's disease and in healthy control participants.
Exploring the feasibility and acceptance of huddinge online prolonged exposure therapy (HOPE) for severe and complex PTSD
Bragesjö M, Ivanov VZ, Andersson E and Rück C
Trauma-focused cognitive behavioural therapy such as prolonged exposure is considered firsthand choice for treatment of posttraumatic stress disorder (PTSD) but is seldom available in regular care. Digital therapy is proposed to bridge this gap, but its effectiveness for severe and complex PTSD is uncertain. The primary objective of the current study was to examine the feasibility, acceptability, and preliminary effects of digital therapist-guided prolonged exposure (Huddinge Online Prolonged Exposure; HOPE). Thirty participants with moderate to severe PTSD, with the majority self-reporting complex PTSD symptoms, received HOPE over a ten-week period. Eighty percent of participants had been diagnosed with other psychiatric comorbidity by a mental health professional. Primary outcome was the feasibility and acceptability of treatment. Participants were repeatedly assessed using clinician- and self-rated outcome measures at baseline, during the treatment period, post-treatment, and at 1-month and 6-month follow-ups to estimate preliminary treatment effects. The Clinician Administered PTSD Scale version 5 (CAPS-5), administered by independent assessors, evaluated PTSD symptom severity.: HOPE proved feasible and effective, delivering evidence-based treatment content in a psychiatric outpatient setting with reduced therapist time. The treatment was well-tolerated, with no severe adverse events and a 17% dropout rate. Sixty-four percent completed the exposure-based portion of the treatment, and overall satisfaction measured by the Client Satisfaction Questionnaire was moderate. Furthermore, significant reductions in PTSD symptoms as assessed with the CAPS-5 (Cohen's  = 1.30 [95% CI -1.79 to -0.82]) at the primary endpoint 1 month which were sustained at the 6-month follow up. Altogether, this study indicate feasibility of treating severe and complex PTSD through a digital PE intervention, thereby building upon and extending previous research findings. Large-scale controlled trials are needed to further validate the specific effect and long-term benefits of HOPE. ClinicalTrials.gov identifier: NCT05560854.
A randomized feasibility trial of the modified Atkins diet in older adults with mild cognitive impairment due to Alzheimer's disease
Buchholz A, Deme P, Betz JF, Brandt J, Haughey N and Cervenka MC
Alzheimer's disease (AD) is increasing in prevalence, but effective treatments for its cognitive impairment remain severely limited. This study investigates the impact of ketone body production through dietary manipulation on memory in persons with mild cognitive impairment due to early AD and explores potential mechanisms of action.
Machine Learning Predicts Conversion from Normal Aging to Mild Cognitive Impairment Using Medical History, APOE Genotype, and Neuropsychological Assessment
Prabhakaran D, Grant C, Pedraza O, Caselli R, Athreya AP and Chandler M
Identifying individuals at risk for mild cognitive impairment (MCI) is of urgent clinical need.
Hope amidst crisis: exploring perinatal mental health and family dynamics in out-of-home care through virtual assessments during the UK COVID-19 response
Iyengar U and Heller-Bhatt J
Caring for a young child exposed to early trauma, along with caregiving stress and heightened by the impact of lockdowns as a result of the COVID-19 response, may compromise the development of the parent-child relationship. Understanding a foster carer's attachment history and considering relational dynamics through an attachment lens may shed light on areas they need support in, to enhance their parenting capacity for vulnerable children. The feasibility of collecting and coding observational data and attachment interviews of foster carers and their children, when conducted remotely during COVID-19, needs to be explored. This perspective piece considers the impact on infant and perinatal health in the context of COVID-19 with particular emphasis on relational dynamics and attachment assessments, using a case study of a foster carer and her child in an out-of-home-care placement. Understanding these dynamics is crucial for safeguarding the well-being of both caregivers and vulnerable children during this challenging time.
CHAMPP4KIDS: Mixed methods study protocol to evaluate acceptability and feasibility of Parenting for Lifelong Health materials in a Canadian context
Gonzalez A, Jack SM, Sim A, Ratcliffe J, Dumbaugh M, Bennett T and MacMillan HL
Parents and caregivers play a key role in children's healthy development and well-being. Traditional parenting interventions promote positive parenting practices and are key to preventing child maltreatment. However, numerous barriers can limit access to programs, barriers which were further exacerbated by the COVID-19 pandemic. The Parenting for Lifelong Health group developed mass media and public health communication materials to promote positive caregiving behaviours on a population level. The Champions of Positive Parenting 4 Kids (CHAMPP4KIDS) study will examine the acceptability and feasibility of these materials for service providers and caregivers of children aged 2-6 years in Ontario, Canada.
Exploring a multimodal approach for utilizing digital biomarkers for childhood mental health screening
Choo M, Park D, Cho M, Bae S, Kim J and Han DH
Depression and anxiety are prevalent mental health concerns among children and adolescents. The application of conventional assessment methods, such as survey questionnaires to children, may lead to self-reporting issues. Digital biomarkers provide extensive data, reducing bias in mental health self-reporting, and significantly influence patient screening. Our primary objectives were to accurately assess children's mental health and to investigate the feasibility of using various digital biomarkers.
Prevalence of mental health conditions and brain fog in people with long COVID: A systematic review and meta-analysis
van der Feltz-Cornelis C, Turk F, Sweetman J, Khunti K, Gabbay M, Shepherd J, Montgomery H, Strain WD, Lip GYH, Wootton D, Watkins CL, Cuthbertson DJ, Williams N and Banerjee A
Long COVID can include impaired cognition ('brain fog'; a term encompassing multiple symptoms) and mental health conditions. We performed a systematic review and meta-analysis to estimate their prevalence and to explore relevant factors associated with the incidence of impaired cognition and mental health conditions.
A welcomed invitation: The feasibility of Trauma Adapted Yoga on a psychiatric inpatient adolescent unit
Khoury NM, Carbone S, Cote J, LePage E, George S, Zhang-James Y, Duquette J and Hagen K
Treatment of patients with anorexia nervosa and comorbid post-traumatic stress disorder; where do we stand? A systematic scoping review
van den Berg E, Pellemans K, Planting C, Daansen P, van Beers E, de Jonge M, Christ C and Dekker J
Comorbid post-traumatic stress disorder in patients with anorexia nervosa may negatively affect the course of anorexia nervosa treatment, which is already challenging. There are currently no guidelines or recommendations on concurrent treatment approaches for both anorexia nervosa and post-traumatic stress disorder. This systematic scoping review aims to explore the feasibility, acceptability and effectiveness of psychological trauma-focused treatment concurrently offered to underweight patients receiving anorexia nervosa treatment.
Self-administered questionnaires enhance emotion estimation of individuals with autism spectrum disorders in a robotic interview setting
Konishi S, Kuwata M, Matsumoto Y, Yoshikawa Y, Takata K, Haraguchi H, Kudo A, Ishiguro H and Kumazaki H
Robots offer many unique opportunities for helping individuals with autism spectrum disorders (ASD). Determining the optimal motion of robots when interacting with individuals with ASD is important for achieving more natural human-robot interactions and for exploiting the full potential of robotic interventions. Most prior studies have used supervised machine learning (ML) of user behavioral data to enable robot perception of affective states (i.e., arousal and valence) and engagement. It has previously been suggested that including personal demographic information in the identification of individuals with ASD is important for developing an automated system to perceive individual affective states and engagement. In this study, we hypothesized that assessing self-administered questionnaire data would contribute to the development of an automated estimation of the affective state and engagement when individuals with ASD are interviewed by an Android robot, which will be linked to implementing long-term interventions and maintaining the motivation of participants.
Spanish version of the short European Health Literacy Survey Questionnaire HLS-Q12: Transcultural adaptation and psychometric properties
Muñoz-Villaverde S, Serrano-Oviedo L, Martínez-García M, Pardo Y, Tares-Montserrat L, Gómez-Romero FJ and Garcimartin P
Health literacy has a direct impact on the health of populations. It is related to education, capacity for self-care, and management of health resources. The Health Literacy Survey Questionnaire HLS-Q12 is one of the reference instruments but has not yet been adapted to Spanish. The aims of the study were to cross-culturally adapt and evaluate the psychometric properties of the Spanish version of the HLS-Q12.
Process and outcome of outpatient psychotherapies under clinically representative conditions in Austria: protocol and feasibility of an ongoing study
Schaffler Y, Jesser A, Humer E, Haider K, Pieh C, Probst T and Schigl B
While most studies assessing psychotherapy efficacy are randomized-controlled trials conducted in research institutions or short clinical treatments, the understanding of psychotherapy effectiveness under regular, clinically representative conditions, particularly in outpatient practice, remains limited. Representative data examining the effectiveness of psychotherapy under real-world conditions in Austria is lacking.
Interpersonal neural synchrony and mental disorders: unlocking potential pathways for clinical interventions
Konrad K, Gerloff C, Kohl SH, Mehler DMA, Mehlem L, Volbert EL, Komorek M, Henn AT, Boecker M, Weiss E and Reindl V
Interpersonal synchronization involves the alignment of behavioral, affective, physiological, and brain states during social interactions. It facilitates empathy, emotion regulation, and prosocial commitment. Mental disorders characterized by social interaction dysfunction, such as Autism Spectrum Disorder (ASD), Reactive Attachment Disorder (RAD), and Social Anxiety Disorder (SAD), often exhibit atypical synchronization with others across multiple levels. With the introduction of the "second-person" neuroscience perspective, our understanding of interpersonal neural synchronization (INS) has improved, however, so far, it has hardly impacted the development of novel therapeutic interventions.
Group Schema Therapy for Refugees with Treatment-Resistant PTSD and Personality Pathology
Verhaak L and Ter Heide JJ
Patients with complex forms of posttraumatic stress disorder (PTSD) may benefit from schema therapy. While a small number of studies point to the effectiveness of individual schema therapy in refugees with PTSD, no evidence on group schema therapy (GST) in refugees exists. To illustrate and advocate for the use of GST in refugee patients with treatment-resistant PTSD and comorbid personality pathology, a case report is presented. . The case concerned the treatment of an East African female refugee who survived sexual and physical violence and loss as a child, as the hostage of a rebel army, and as a victim of human trafficking. She was diagnosed with PTSD, major depressive disorder, and borderline personality disorder. Trauma-focused therapy was hampered by insufficient treatment attendance due to current stress factors and early destructive coping strategies. One year of GST enabled the patient to overcome treatment-undermining patterns and benefit from subsequent trauma-focused therapy.
Helping Educational Leaders Mobilize Evidence (HELM): The iterative redesign of the Leadership and Organizational Change for Implementation (LOCI) intervention for use in schools
Locke J, Corbin CM, Collins VK, Ehrhart MG, Goosey R, Hatch K, Espeland C, Cook CR and Lyon AR
Few "intervention agnostic" strategies have been developed that can be applied to the broad array of evidence-based practices (EBPs) in schools. This paper describes two studies that reflect the initial iterative redesign phases of an effective leadership-focused implementation strategy-Leadership and Organizational Change for Implementation (LOCI)-to ensure its acceptability, feasibility, contextual appropriateness, and usability when used in elementary schools. Our redesigned strategy-Helping Educational Leaders Mobilize Evidence (HELM)-is designed to improve principals' use of strategic implementation leadership to support the adoption and high-fidelity delivery of a universal EBP to improve student outcomes.
Intraindividual time-varying dynamic network of affects: linear autoregressive mixed-effects models for ecological momentary assessment
Pooseh S, Kalisch R, Köber G, Binder H and Timmer J
An interesting recent development in emotion research and clinical psychology is the discovery that affective states can be modeled as a network of temporally interacting moods or emotions. Additionally, external factors like stressors or treatments can influence the mood network by amplifying or dampening the activation of specific moods. Researchers have turned to multilevel autoregressive models to fit these affective networks using intensive longitudinal data gathered through ecological momentary assessment. Nonetheless, a more comprehensive examination of the performance of such models is warranted. In our study, we focus on simple directed intraindividual networks consisting of two interconnected mood nodes that mutually enhance or dampen each other. We also introduce a node representing external factors that affect both mood nodes unidirectionally. Importantly, we disregard the potential effects of a current mood/emotion on the perception of external factors. We then formalize the mathematical representation of such networks by exogenous linear autoregressive mixed-effects models. In this representation, the autoregressive coefficients signify the interactions between moods, while external factors are incorporated as exogenous covariates. We let the autoregressive and exogenous coefficients in the model have fixed and random components. Depending on the analysis, this leads to networks with variable structures over reasonable time units, such as days or weeks, which are captured by the variability of random effects. Furthermore, the fixed-effects parameters encapsulate a subject-specific network structure. Leveraging the well-established theoretical and computational foundation of linear mixed-effects models, we transform the autoregressive formulation to a classical one and utilize the existing methods and tools. To validate our approach, we perform simulations assuming our model as the true data-generating process. By manipulating a predefined set of parameters, we investigate the reliability and feasibility of our approach across varying numbers of observations, levels of noise intensity, compliance rates, and scalability to higher dimensions. Our findings underscore the challenges associated with estimating individualized parameters in the context of common longitudinal designs, where the required number of observations may often be unattainable. Moreover, our study highlights the sensitivity of autoregressive mixed-effect models to noise levels and the difficulty of scaling due to the substantial number of parameters.
Nature-based virtual reality intervention to manage stress in family caregivers of allogeneic hematopoietic stem cell transplant recipients: a two-phase pilot study protocol
Lee LJ, Son EH, Farmer N, Gerrard C, Tuason RT, Yang L, Kohn-Godbout J, Stephens C, Nahm ES, Smith L, Risch S and Wallen GR
Millions of family members and/or friends in the U.S. serve as unpaid caregivers for individuals with chronic conditions, such as cancer. Caregiving for someone undergoing an intense allogeneic hematopoietic stem cell transplant (HSCT) is particularly demanding, with accompanying physical and psychological stress. Increased stress and stress-related symptoms could make it difficult for caregivers to fulfill their roles and could negatively impact the health status and quality of life of themselves and the recipients. Virtual reality (VR) is a promising technology increasingly used for treatment and wellness in various medical settings. There is growing evidence that studies have reported the positive effects of the VR intervention in managing and reducing stress among diverse populations in various clinical scenarios; however, no published studies have focused on family caregivers of patients with cancer. The study aims to assess the feasibility and acceptability of a four-week nature-based VR intervention and to examine the effectiveness of the VR intervention on stress in HSCT caregivers. This study comprises two phases. Phase I of the study will be a single-arm pre-post design focused on assessing the feasibility and acceptability of the VR intervention. Phase II of the study will be a prospective randomized controlled group design to examine the effectiveness of the VR intervention on perceived stress. Adults (≥ 18 years) who serve as primary caregivers for a person who will undergo an allogeneic HSCT will be recruited. Fifteen participants will be enrolled for Phase I and 94 participants for Phase II (Active VR arm N=47; Sham VR arm N=47). The nature-based immersive VR program contains 360° high-definition videos of nature scenes along with nature sounds through a head-mounted display (HMD) for 20 minutes every day for four weeks. Primary outcome is perceived stress measured by the Perceived Stress Scale. Secondary/exploratory outcomes are stress-related symptoms (e.g., fatigue, sleep disturbance) and physiological biomarkers (e.g., cortisol, alpha-amylase). The importance and innovativeness of this study consist of using a first-of-its-kind, immersive VR technology to target stress and investigating the health outcomes assessed by validated objective biomarkers as well as self-report measures of the nature-based intervention in the caregiver population.
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