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

Study Overview
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Brief Summary
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Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been associated with anxiety and depressive symptoms, as well as an increased risk of relapse back to the drinking. Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I may be efficacious for insomnia during recovery. The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if an improvement in the insomnia is associated with an improvement in the underling alcoholism and the daytime functioning. On an exploratory basis, the association of a first-degree family history of alcoholism with the insomnia severity and treatment response will also be evaluated.

Detailed Description
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Eligible subjects will be Veterans with alcohol dependence during their first year of recovery, 21-65 years old, with ISI total score of 15 or more, medically and psychiatrically stable, and without dependence on other drugs (with the exception of nicotine and marijuana). The proposed study will consist of a single-blind trial comparing CBT-I against a behavioral placebo intervention (Quasi-Desensitization Therapy, QDT). Baseline assessments conducted over a month will comprehensively evaluate for the addiction, psychiatric, sleep and medical disorders, as well as for a family history of alcohol dependence. Once the subject is seen to be eligible for the study he will be randomized to either the CBT-I or the QDT arm, and treated for the next weeks. The primary outcome measure for insomnia will be the Insomnia Severity Index. The primary outcome measure for alcohol dependence will be the percent days abstinent (on the Time Line Follow Back measure, TLFB), and the daytime symptoms will be assessed using the Short Form-12 item scale (SF-12, for self reported well-being), the Beck Depression Inventory (BDI, for depressive symptoms), and the State Trait Anxiety Inventory (STAI, for anxiety symptoms). After completion of the treatment phase, subjects will be followed up 3 months and 6 months later, to assess for changes over time in their insomnia, alcohol use, and daytime functioning.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female Veterans between the ages of 21 and 70 years DSM IV diagnosis of alcohol dependence over the past year (as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders [SCID-I]) Self-reported sleep latency or wake time after sleep onset >30 min on three or more nights per week for 1 month and a score of 15 or more on the Insomnia Severity Index (ISI) No current alcohol withdrawal symptoms at baseline: CIWA score < 8 (CIWA is the Clinical Institute Withdrawal Assessment scale for alcohol withdrawal signs and symptoms) Abstain for at least 4 weeks from heavy drinking, and < 12 months of abstinence from heavy drinking prior to the baseline study assessments, as assessed by subjective report or breathalyzer Ability to speak, understand and print in English Capacity to give written informed consent Exclusion Criteria: DSM-IV criteria for dependence on any other substance including benzodiazepines (and excluding nicotine dependence) Positive urine drug screen for opioids, cocaine, or amphetamine (positive screen for Tetra Hydro Cannabinol is not considered an exclusion criteria) Patient is currently in alcohol withdrawal as assessed by the Clinical Institute Withdrawal Assessment Scale (CIWA) total score of 8 or more A lifetime DSM-IV diagnosis of Bipolar I or II disorder, Schizophrenia, or other psychotic disorder, as determined on the SCID-I, and current (past month) DSM-IV diagnosis of Major Depressive Disorder Presence of unstable medical diagnosis e.g. congestive heart failure, leading to interference with sleep, as reported on history, examination, and/or review of clinical chart during baseline assessments Current use of any medications that may influence the drinking behavior, e.g. naltrexone or acamprosate Evidence of severe cognitive impairment as assessed by the Blessed Orientation-Memory-Concentration (BOMC) test weighted score Untreated patients with the diagnosis of moderate-severe obstructive sleep apnea with Total Apnea-Hypopnea Index (AHI-T) of 15 events/hour of sleep Subject's inability to give informed consent

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-I<br>Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 & 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia. | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)<br>* Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.<br>|
| Placebo Comparator: QDT<br>This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate conditioned arousal, occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime. | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)<br>* Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index - Total Score | Insomnia Severity Index (ISI): This 7-item (0-4 Likert scales) measure yields a total score of 28. The norms for the scale are as follows: 0-7 represents no clinically significant insomnia; 8-14 represents sub threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The scale provides a measure of severity of insomnia (overall), a measure of insomnia subtype, a measure of the diurnal effects of insomnia, and a measure of sleep satisfaction. The ISI will be completed at baseline and for all the subsequent study-related visits. | 8 weeks, 3 months post-treatment, and 6 months post-treatment | 
| Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure | Time Line Follow Back measure (TLFB): The TLFB provides assessment of drinking using a calendar format for the number of standard alcoholic beverages consumed per day. A standard drink, as defined by the National Institutes of Health, is 12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits (e.g. whiskey). Numerous indices may be derived from the TLFB, such as the Percent Days Abstinent (PDA) proposed in this study. The PDA is derived as the percentage of days an individual reports being abstinent from alcohol within a given assessment time period. | 8 weeks, 3 months post-treatment and 6-months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Sleep initiation and maintenance disorder, Alcoholism, Cognitive behavioral therapy for insomnia