Study Objectives 1) To determine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving insomnia, alcohol-related outcomes, and daytime functioning at post-treatment and at 3- and 6- month follow-up, in a largely African American Veteran sample; 2) Evaluate whether improvement in insomnia is associated with a reduction in alcohol-related outcomes post-treatment.
Methods An RCT of CBT-I (n = 31) compared to Quasi-Desensitization therapy (QDT, n = 32), eight weekly in-person sessions, with assessments at baseline, end of treatment (8 weeks), and 3- and 6-months post-treatment. Primary outcomes were the Insomnia Severity Index (ISI) total score, and Percent Days Abstinent (PDA). Secondary outcomes were sleep diary variables, drinks per day, percentage non-heavy drinking days, Penn Alcohol Craving Scale, PCS and MCS scale (from the SF-12), BDI and STAI-Trait subscale total scores.
Results Post-treatment data were obtained from 88.9% of participants. Although CBT-I improved insomnia with effect sizes (E.S.) larger than the meta-analytic estimates, QDT was equally efficacious in improving insomnia (E.S. = -1.63 vs. -1.50), improving abstinence (E.S. = 1.54 vs. 1.91) and next-day functioning (E.S. = - 0.26 vs. -0.17). Across treatment groups, remission from insomnia was associated with a lower post-treatment alcohol craving score (2.79, 95% CI 1.14, 4.44 vs. 9.51, 95% CI 6.06, 12.95 in non-responders), an effect that persisted for 6 months after treatment.
Conclusions CBT-I and QDT are equally effective for treating insomnia during early recovery from AUD. Reduced alcohol craving may be a mechanism by which a remission from insomnia improves drinking outcomes.
The study was registered on ClinicalTrials.gov: NCT01987089.
Statement of Significance Insomnia is prevalent in alcohol use disorder (AUD) and predicts relapse during early recovery from pathological drinking. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a promising treatment for this co-occurring condition. This randomized-controlled study, with a predominantly African-American sample, compared CBT-I to Quasi-Desensitization Therapy (QDT), an active placebo. Both treatments effectively improved insomnia, promoted abstinence, and enhanced next-day functioning. Importantly, across the entire sample, remission from insomnia was associated with reduced alcohol craving for up to six months after treatment. However, QDT proved equally efficacious as CBT-I in treating insomnia during early recovery from AUD. These findings suggest that while remission from insomnia may be associated with reduced alcohol craving, QDT was as efficacious as CBT-I in promoting recovery.
Competing Interest StatementNone of the authors report any conflict of interest with this investigation.
Clinical TrialNCT01987089
Funding StatementThe VA Clinical Sciences Research and Development grant IK2CX000855 provided funding for the conduct of this trial (SC).
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
IRB of Cpl. Michael J. Crescenz Veterans Affairs Medical Center gave ethical approval for this work
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityAny dataset from this study cannot be released as per the directive of the IRB at CMCVAMC.
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