The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse|
- Insomnia Severity Index - total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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.
- Percent Days Abstinent (PDA) on the Time Line Follow back measure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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). Heavy drinking is defined as consumption of > 4 standard drinks in one day or the consumption of 14 standard drinks in one week in males, and > 3 standard drinks a day or more than 7 drinks a week in females. Numerous indices may be derived from the TLFB, including those proposed for the present study: Percent Days Abstinent (PDA), number of drinking days, proportion of drinking days, and proportion of days of heavy drinking.
- Short Form - 12 item (SF-12) measure [ Time Frame: Baseline, and 8 weeks ] [ Designated as safety issue: No ]The SF-12 self-report instrument is a measure of subjective well-being. This instrument yields 2 summary scales and 8-scale profiles. The 8-scale profiles are the General Health, Physical Functioning, Role Functioning (physical), Bodily Pain, Vitality, Role Functioning (emotional), Mental Health, and Social Functioning. The summary scales are the Physical Component Summary (PCS) and Mental Component Summary (MCS). Both of the summary scales range from 0 (indicating the lowest level of health) to 100 (indicating the best level of health).
- Beck Depression Inventory (BDI - II) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]This 21-item self-report questionnaire assesses for depressive symptoms as well as depressive disorder. Each of the 21 items is rated on a 4-point scale from 0-3, yielding a summary score range of 0-63. The BDI-II total score of 0-13 is consistent with minimal depression, 14-19 with mild depression, 20-28 with moderate depression, and 29-63 with severe depression. The BDI-II will be used to assess for change in minor mood symptoms, as is recommended as part of the research-related assessment for insomnia102 and as has been used in a prior study of CBT-I in recovering alcohol-dependent subjects with insomnia9.
- State Trait Anxiety Inventory (STAI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The STAI is one of the most widely used instruments assessing for self-reported anxiety symptoms in insomnia research. The STAI measures anxiety as both a current state ("feeling right now") and an enduring trait ("generally feel"), each evaluated with 20 items scored on a scale from 0 (not at all") to 3 ("very much so"). The trait portion of the STAI (STAI-T) is recommended for use in insomnia research studies. The scores of the trait anxiety range from 20 (mild) to 80 (severe). We will use the STAI to assess for trait anxiety symptoms commonly associated with insomnia, which is recommended for the research-related assessment for insomnia and which has been used in a prior study of CBT-I in recovering alcohol-dependent subjects with insomnia.
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||June 2019 (Final data collection date for primary outcome measure)|
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)
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
Placebo Comparator: QDT
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01987089
|Contact: Subhajit Chakravorty, MD||(215) 823-5800 ext 4391||Subhajit.Chakravorty@va.gov|
|United States, Pennsylvania|
|Philadelphia VA Medical Center, Philadelphia, PA||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Subhajit Chakravorty, MD 215-823-5800 ext 4391 Subhajit.Chakravorty@va.gov|
|Principal Investigator: Subhajit Chakravorty, MD|
|Principal Investigator:||Subhajit Chakravorty, MD||Philadelphia VA Medical Center, Philadelphia, PA|