Online mindfulness-based cognitive therapy for people with multiple sclerosis with mild-to-moderate depression- protocol for a type 1 hybrid effectiveness-implementation study
AI Summary
Type 1 hybrid effectiveness-implementation randomised waitlist trial of online 8-week MBCT in ≥152 people with MS and mild to moderate depression. Primary outcome HADS-D.
Embedded mixed methods including 30-40 semi-structured interviews with participants, clinicians, instructors and decision-makers; thematic analysis and RE-AIM PRISM implementation evaluation.
Study will provide evidence on online MBCT effectiveness, inform tailoring and implementation strategies for PwMS with mild-moderate depression; results widely disseminated.
PLoS One. 2026 Nov 13;21(11):e0362553. doi: 10.1371/journal.pone.0362553. eCollection 2026.
ABSTRACT
BACKGROUND: Mindfulness-based cognitive therapy (MBCT) is an effective treatment for recurrent depression in the general population and is recommended in clinical guidelines for those with mild-moderate depression. However, the effectiveness of MBCT in people with multiple sclerosis (PwMS) with mild to moderate depression is unknown. Further, how best to tailor and implement MBCT for PwMS is largely unstudied. This manuscript describes the study protocol for a hybrid-effectiveness study to evaluate online MBCT tailored for PwMS.
METHODS: This type 1 hybrid effectiveness-implementation study will employ an embedded mixed methods experimental design. Quantitative findings will be collected through a powered waitlist randomized controlled trial examining online MBCT in a minimum of 152 PwMS with case-ness of mild-moderate depression (Clinical Trials Gov #NCT07742579). The intervention will consist of an online 8-week MBCT course with weekly sessions conducted by qualified mindfulness instructors experienced int the care of PwMS. Questionnaires will be collected at baseline, post-intervention, and 3 months later. The primary outcome will be depression, measured using the Hospital Anxiety and Depression Score – Depression (HADS-D). An intention-to-treat analysis will be conducted. Qualitative findings will be collected through semi-structured interviews with 30-40 MBCT participants, HCPs, MBCT instructors, and MS decision makers. Thematic analyses will be used to analyze interview data. The RE-AIM PRISM tool will be used to evaluate implementation and mixed data assessed in a joint display.
CONCLUSION: The results from this study will provide evidence regarding the effectiveness of online MBCT in PwMS with mild to moderate depression, recommendations for intervention tailoring and implementation. Findings will be disseminated through traditional and novel, creative knowledge mobilization methods.
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