Abstract

Abstract Introduction There is an established association between insomnia and suicide. As with many conditions, the preponderance of patients with either insomnia or with suicidal ideation (SI) are seen in primary care settings. Brief forms of cognitive behavioral therapy for insomnia (bCBTi) have been delivered in primary care including to patients with mental health conditions. We sought to test the efficacy of bCBTi among primary care insomnia patients endorsing SI. Methods A sample of 194 participants endorsing SI and meeting criteria for insomnia disorder along with depression and/or posttraumatic stress disorder (PTSD) were randomly assigned to receive either four weekly sessions of bCBTi (n=98) or Sleep Hygiene (n=96). Participants engaged in suicide safety planning or a review of their existing safety plan. To be consistent with the primary care milieu, intervention sessions averaged < 30 minutes in duration with all intervention sessions audio-recorded and subjected to fidelity ratings. Outcome measures include the: Insomnia Severity Index (ISI; primary endpoint): Scale for Suicidal Ideation (SSI); Patient Health Questionnaire-Depression (PHQ-9); and PTSD Symptom Checklist-DSM 5 (PCL-5) administered at baseline and 6, 12, 18, 24, and 30-week follow-ups. Mixed effect analyses will test for linear change in each outcome over time, as well as examining intervention effects on these trajectories. The study also gathers initial data on barriers and facilitators to aid future implementation efforts. Results The study sample consists of 194 U.S. Military Veterans with a mean (sd) age of 51.5 (13.7) years, 23% of whom are female, 17% racial minorities and 9% ethnic minorities. Mean baseline values for the outcome measures are: ISI 19.1 (4.1); SSI 3.5 (5.3); PHQ-9 15.2 (5.1); and PCL-5 43.4 (14.3). Data collection will be completed in Spring 2023. In addition to complete enrollment and retention data, we will present results of analyses on primary (ISI) and secondary (SSI, PHQ-9, PCL-5) outcomes across all time points. Conclusion This randomized trial was designed to establish the feasibility and effectiveness of treating insomnia in primary care environments as a suicide prevention strategy while gathering data to facilitate implementation if the findings warrant. Support (if any) U.S. Department of Veterans Affairs Office of Research & Develpment (I01 HX002183)

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