Stepped care for insomnia in primary care using digital and face-to-face cognitive behavioral therapies: A pragmatic nonrandomized clinical trial

Sleep Med. 2025 May 3;132:106551. doi: 10.1016/j.sleep.2025.106551. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of a stepped-care intervention for insomnia in primary care.

METHODS: In this non-randomized pragmatic clinical trial, patients from primary care clinics and with chronic insomnia disorder were allowed to choose between continuing their usual treatment (prescribed sleep medication) or receiving digital CBT-I (dCBT-I), either alone or in combination with medication. After the first treatment step, non-remitters were provided with the choice of receiving face-to-face CBT-I (FtFCBT-I), medication, or no additional treatment. The primary outcome was insomnia symptoms as measured by the Insomnia Severity Index.

RESULTS: Among 154 adults with insomnia, 73 were allocated to dCBT-I, 66 to combined treatment and 15 to medication alone based on their preference. When compared to medication alone, first-step treatment with dCBT-I or combined treatment both produced significantly larger effects on reducing insomnia severity (dCBT-I vs Med, difference in the mean changes = -3.3; Comb vs Med, -3.7), and led to higher percentages of responders (dCBT-I vs Med, 54.8 % vs 16.0 %, OR = 6.38; Comb vs Med, 53.6 % vs 16.0 %, OR = 6.07) and remitters (dCBT-I vs Med, 65.8 % vs 9.4 %, OR = 18.61; Comb vs Med, 67.5 % vs 9.4 %, OR = 20.13). Adding FtFCBT-I as second-step treatment offered an added value for non-remitters after the first-step treatment. Improvements achieved at post-treatment were sustained through the 6-month follow-up for most of the treatment sequences.

CONCLUSIONS: These findings demonstrated the feasibility and efficiency of implementing digital and in-person CBT-I within a stepped-care model in primary care practice.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03633305.

PMID:40373353 | DOI:10.1016/j.sleep.2025.106551