The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse

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DESCRIPTION (provided by applicant): Alcoholism and insomnia are highly prevalent in Veterans. Alcoholism is estimated to occur in about 6.4% of Veterans. More recent estimates of alcohol misuse range from 11.8% in OIF Veterans to 21.8% in OEF/OIF male Veterans. Insomnia is estimated to occur in about 28% of active duty military personnel (from the Millennium Cohort Study), and up to 77% of Veterans seen in a VHA primary care experience clinically significant levels of insomnia. Insomnia is also highly prevalent in patients recovering from alcoholism with as many as 70% of such patients complaining of sleep initiation and/or maintenance problems. These prevalence rates are 2-7 times higher than that of the general population. The direct consequences of insomnia include sleepiness, fatigue, irritability, diminished work performance and impaired interpersonal functioning. The long- term sequelae of insomnia include risk for new-onset and recurrent psychiatric illness, and in the context of alcoholism, greater intensity of alcoholism and increased risk for relapse in abstinent alcoholics. At present, there are nine studies which evaluate whether insomnia represents a modifiable risk factor for relapse of alcoholism (2 investigating trazodone, 3 investigating gabapentin, 1 investigating ramelteon, and 3 investigating a modified form of cognitive-behavioral therapy for insomnia [CBT-I]). The results from these studies are variable. The CBT-I investigations show the most promise in terms of improved sleep, but there is no clear evidence that improved sleep has protective value against pathological drinking. Accordingly, CBT-I (n=30) will be evaluated and compared to the Quasi-Desensitization Therapy (QDT) (n=30) in a sample of veterans who have been sober for at least one month (but less than one year). The study cohort will be further stratified into those who do (n=30) and do not (n=30) have a first-degree family history of alcoholism. Familial alcoholism is taken into account, as this may represent a unique factor that contributes to insomnia severity and/or treatment outcome. All subjects will complete a 2-week baseline recording period followed by weekly CBT-I/QDT sessions for 8-weeks. CBT-I will be conducted according to a standard protocol. Weekly 1-hour sessions (individual format) will be used to deliver the four components of CBT-I (Sleep Restriction, Stimulus Control, Sleep Hygiene, and Cognitive therapy [sleep-related de-catastrophization]). Treatment will be followed up with two evaluations at 3 and 6 months post-intervention. All subjects will complete the Insomnia Severity Index, daily sleep diaries, and the alcohol-related measures for a 2-week baseline, for the intervention period, and for two follow-up intervals after treatment completion at 3 and 6 months. The primary outcome measures are insomnia severity (as assessed with the ISI) and percentage days abstinent (as assessed using the Timeline Follow Back measure). In addition, health and mood will be tracked using the Short Form-12 (SF-12) item scale, the BDI-II, PHQ9, STAI, and the GAD7. The combination of these measures serve to test the hypotheses that standard CBT-I can be applied successfully in patients recovering from alcoholism and that successful treatment of insomnia will be associated with better clinical outcomes in relation to alcoholism. Finally, family history data will be assessed on an exploratory basis to assess differences in baseline insomnia and objective sleep, as well as outcomes for the insomnia, alcoholism, treatment adherence, and/or treatment outcome. Objective sleep will be preliminarily assessed with in-laboratory polysomnograms of seven subjects with and without familial alcoholism (n=16). It is hypothesized that CBT-I in abstinent alcoholics will lead to 1) significantly superio sleep-related outcomes as compared to QDT, 2) pre-to-post treatment effect sizes that are comparable to the meta-analytic norms, 3) a larger percentage of days abstinent with at least a trend toward fewer relapses, and 4) better overall health and mood. If these findings are achieved and replicated, it will suggest that insomnia treatment should be a standard component in the management of alcoholism and that CBT-I is an ideal management approach for this co-morbid insomnia.