Mary Beth Miller, Ryan W Carpenter, Sydney D Shoemaker, Katie R Moskal, Brian Borsari, Eric R Pedersen, Bruce D Bartholow, Douglas Steinley, Christina S McCrae
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引用次数: 0
Abstract
Study objectives: Two in five Veterans report symptoms of insomnia, with higher rates among those who drink heavily. Although Cognitive Behavioral Therapy for Insomnia (CBT-I) has demonstrated efficacy among those with Alcohol Use Disorder, abstinence is often considered a prerequisite for treatment, leaving its impact unclear among those who are actively drinking. This trial tested the efficacy of CBT-I among heavy-drinking Veterans with insomnia (#NCT03804788).
Methods: Veterans from across the United States were randomly assigned to CBT-I or sleep hygiene control. Participants completed retrospective surveys and 14 sleep diaries at baseline, post-treatment, and 3-month follow-up. Primary outcomes were feasibility and insomnia severity. All other outcomes are secondary/exploratory. Intent-to-treat analyses were conducted using multilevel models.
Results: Recruitment spanned June 2019 to March 2023 (N = 71, 80% male, M = 38 years). On average, we recruited 4 participants per month, with retention of 86% at post-treatment and 90% at follow-up. Of 38 CBT-I participants, 33 (87%) completed all 5 treatment sessions, and most responded to treatment (based on change in outcome scores; 22/38 at post, 27/38 at follow-up). Relative to control (n = 33), CBT-I participants reported large improvements in insomnia severity, both post-treatment [d = 1.26 (95% CI: 0.74, 1.76)] and at 3-month follow-up [d = 1.33 (95% CI: 0.81, 1.84)]. At follow-up, results for use of alcohol as a sleep aid [d = 0.66 (95% CI: 0.18, 1.14)] and sleep medication [d = 0.44 (95% CI: -0.03, 0.91)] also favored CBT-I.
Conclusions: CBT-I is feasible among heavy-drinking Veterans and has large effects on insomnia severity. Studies testing mechanistic effects on alcohol outcomes are warranted.
Clinical trial information: The iTAP Study for Veterans, registered on clinicaltrials.gov (#NCT03804788) on January 11, 2019: https://clinicaltrials.gov/study/NCT03804788?term=NCT03804788&rank=1.