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Results of a pilot randomized controlled trial of CBT-I for veterans with serious mental illness and insomnia

J Clin Sleep Med. 2026 Jan 29;22(1):22. doi: 10.1007/s44470-025-00009-z.

ABSTRACT

STUDY OBJECTIVES: For Veterans living with a serious mental illness (SMI), insomnia is prevalent and harmful. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective treatment, but Veterans with SMI experience significant environmental, psychological, and systemic barriers to receiving and benefiting from it. There is limited clinical guidance on using CBT-I with Veterans with SMI. We developed provider guidelines and patient materials for conducting CBT-I when these barriers are present for people with SMI (CBT-I for SMI) and evaluated the acceptability and preliminary efficacy of CBT-I for SMI in an assessor-blind randomized controlled trial.

METHODS: Forty-seven Veterans with insomnia and SMI were randomized to either CBT-I for SMI (n = 26) or Health and Wellness (HW; n = 21), an active control condition. At baseline, post-treatment, and 3-month follow-up, participants completed: actigraphy and daily sleep diaries for two weeks and self-report measures of insomnia and functioning. At 3-month follow-up, participants completed satisfaction ratings of treatment.

RESULTS: CBT-I for SMI participants had high treatment satisfaction and attendance. At post, compared to HW, CBT-I caused statistically significantly greater reductions in diary-measured time-in-bed, increases in diary-measured sleep efficiency, reductions in actigraphy-measured time-in-bed and total sleep time, and improvements in self-reported insomnia severity and sleep-related functioning; relative to CBT-I, HW improved community participation.

CONCLUSIONS: CBT-I for SMI is acceptable to Veterans with SMI and improves sleep and functioning. Future research should examine how sleep mediates effective functional gains, identify how CBT-I could be integrated within recovery centers, and develop preventative interventions to curtail insomnia-associated functional decline. People with serious mental illnesses experience challenges to receiving and benefiting from Cognitive Behavioral Therapy for Insomnia. To support providers and patients, we developed guidelines and materials for navigating these challenges while conducting Cognitive Behavioral Therapy for Insomnia with people with serious mental illness. In the first study to compare Cognitive Behavioral Therapy for Insomnia conducted with our materials and guidelines to an active treatment control, we found that our guideline-led Cognitive Behavioral Therapy for Insomnia improved self-reported insomnia severity, sleep-related functioning, and actigraphy and diary-measured sleep of Veterans with serious mental illness and insomnia. Veterans with serious mental illness can participate in, derive satisfaction from, and benefit from Cognitive Behavioral Therapy for Insomnia when this treatment is appropriately tailored.

PMID:41678078 | DOI:10.1007/s44470-025-00009-z

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