Abstract Introduction Insomnia is frequently comorbid with alcohol misuse. Cognitive behavioral therapy for insomnia (CBTi) improves insomnia in adults treated for alcohol use disorder but has seldom been modified to address alcohol use or tested in less severe, non-clinical samples with hazardous alcohol use (HAU). A two-phase study was designed to assess feasibility, acceptability and effect of CBTi modified to address insomnia and co-occurring HAU (CBTi-HAU) in an open label trial and a subsequent pilot randomized clinical trial (RCT). Methods The open label trial (N=10) enrolled community-dwelling adults with Chronic Insomnia Disorder and HAU. Following intervention refinements, the RCT (Target N=60) randomized similar participants to CBTi-HAU or Control (CTRL). Interventions were delivered over telehealth in 4 weekly individual sessions supplemented by a patient workbook. CBTi-HAU consisted of standard CBTi components adapted to include several alcohol reduction strategies with daily sleep/alcohol diaries. CTRL included sleep education, alcohol education and alcohol reduction strategies with 1-week of diaries prior to session 1 only. Measures: Insomnia Severity Index (ISI); the Short Inventory of Problems for alcohol–Revised (SIP-R); and percent days abstinent (PDA), percent heavy drinking days (PHDD) and drinks per drinking day (DDD) extracted from a 30-day Timeline Followback (TLFB) interview. Pre-post assessments occurred in the open trial with the addition of 12 and 24-week follow-ups in the RCT. For the open label trial, we evaluated pre-post differences with paired t-tests. Final RCT results will be available to present. Results All 10 open label participants completed treatment with 9 completing post-treatment assessments. Therapist feedback supported feasibility. Patient feedback was largely positive and supported acceptability. A pre-post reduction of 10.7 ISI points was observed (p 0.001; 95% CI, 8.5-12.8). Reductions in SIP-R (p=.05) and PHDD (p=.04), but not PDA (p=.33) or DDD (p=.52), were also observed. In the RCT, 47 participants (mean ISI = 17.1+/-3.0; 47.3+/-8.8 years old, 57% female, 15% minority) were randomized through Nov 2025 with 96% retention to date. Final results will be presented. Conclusion CBTi-HAU is a promising intervention for improving insomnia with mixed findings for alcohol use and its behavioral consequences. Support (if any) National Institute on Alcohol Abuse and Alcoholism (R34AA029506)
Pigeon et al. (Fri,) studied this question.