Testing CBT Models and Change Mechanisms for Alcohol Dependent Women

Study Overview
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Brief Summary
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The study has 4 specific aims: (1) To modify our existing Individual Female Specific Cognitive Behavioral Therapy (I-FS-CBT) for Alcohol Use Disorder (AUD) approach to treat women with alcohol dependence in a group format, Group Female Specific Cognitive Behavioral Therapy (G-FS-CBT); (2) To test the relative efficacy of I-FS-CBT and G-FS-CBT; (3) To test hypothesized mechanisms of change in drinking that are common to both treatments, including (a) coping skills and enhanced self-efficacy for abstinence; (b) enhanced sense of autonomy; (c) alleviation of negative affect, and (d) increased social network support for abstinence, and (4) To assess the relative cost-effectiveness of the individual and group treatment.

Detailed Description
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Participants completed a telephone screen for initial eligibility and were scheduled for an in-person clinical intake interview. Consented women were scheduled for a baseline research interview (BL) approximately one week later. At the end of the BL, participants were randomized to treatment condition. During the 12 session treatment period, women completed assessments at the beginning and end of each therapy session on secondary outcome and therapy process variables. In I-FS-CBT each participant saw a therapist weekly. The first session was 90 minutes long, and subsequent sessions were 60 minutes long. The I-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence and (b) self-care. The G-FS-CBT manual included material identical to I-FS-CBT, but the session organization was modified for a closed group format. The group treatment was designed to provide didactic presentation of coping skills and motivational enhancement material, and group discussion and rehearsal of new skills within a supportive atmosphere that facilitated mutual emotional support and support for abstinence. The first session of G-FS-CBT was 2 hours; remaining sessions were 90 minutes. In-person follow-up interviews were done at 3, 9, and 15 months post-session 1.

Official Title
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Testing CBT Models and Change Mechanisms for Alcohol Dependent Women

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: I-FS-CBT
* Behavioral: G-FS-CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or older have a current (past year) Diagnostic and Statistical Manual-IV (DSM-IV) alcohol dependence diagnosis used alcohol in the 60 days prior to telephone screening Exclusion Criteria: have psychotic symptoms in the past six months gross cognitive impairment current physiological dependence on any illicit drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-FS-CBT<br>In I-FS-CBT each participant saw a therapist weekly. The first session was 90 minutes long, and subsequent sessions were 60 minutes long. The I-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence, and (b) self-care. | Behavioral: I-FS-CBT<br>* 12 manual-guided sessions of I-FS-CBT<br>|
| Experimental: G-FS-CBT<br>The G-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence, and (b) self-care. The session organization was modified for a closed group format. The group treatment was designed to provide didactic presentation of coping skills and motivational enhancement material, and group discussion and rehearsal of new skills within a supportive atmosphere that facilitated mutual emotional support and support for abstinence. | Behavioral: G-FS-CBT<br>* 12 manual-guided sessions of G-FS-CBT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Drinking Days (PDD) | Derived from Timeline Followback (TLFB) | Change from baseline across 15 months post-session 1 | 
| Percent Heavy Drinking Days (PHDD) | Derived from TLFB; Defined as 4 or more standard drinks per day | Change from baseline across 15 months post-session 1 | 
| Mean Drinks Per Drinking Day (MDPDD) | Derived from TLFB | Change from baseline across 15 months post-session 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory II | self-report questionnaire assessing depression symptoms over the prior two weeks (scores range 0-63) and higher scores indicate greater depression symptomatology. All item scores are summed to attain a total score. | Baseline and through study completion, about 15 months | 
| Anxiety | Assessed anxiety symptoms in the last week (scores range 0-63) with higher scores indicating higher anxiety symptomatology. Item scores summed to attain total score. | Baseline and through study completion, about 15 months | 
| Sociotropy-Autonomy Scale | Measures the extent of an individual's concern with others' opinion of herself (sociotropy) and self-confidence, behavioral and emotional independence (autonomy). Sociotropy sub scale ranges from 0 to 64 with higher scores indicating higher sociotropy. Average Sociotropy Scores are attained by averaging items, with total scores from 0 to 4. Autonomy sub scale Score range from 0 to 44 with higher scores indicating greater autonomy. Average Autonomy Scores are attained by averaging items, with total scores from 0 to 4. | Baseline and through study completion, about 15 months | 
| Coping Strategies Scale | Assessed use frequency of 30 strategies to cope with alcohol use and non-alcohol related situations, on a scale of 1 (never) to 4 (frequently) for a mean score across all items | Baseline and through study completion, about 15 months | 
| Situational Confidence Scale 8 | Measured self-efficacy to abstain from alcohol use in high-risk situations; each item is rated 0% to 100% for a global confidence score. | Baseline and through study completion, about 15 months | 
| Important People Inventory | Assessed social network structure, network drinking, and network response to drinking and abstinence. Percentage of network accepting/encouraging abstinence and percentage of network abstainers/in recovery were used. | Baseline and through study completion, about 15 months | 
| Self care | Assessed 8 domains of self-care: seek medical care, have free time, pleasurable activities, social contact, attend treatment, exercise, do nice things for oneself, buy nice things for oneself | Baseline and through study completion, about 15 months | 
| Inventory of Personal Problems | Assessed problems in 10 interpersonal domains, rated on a 0 to 4 scale. A total sum score was used for this study; higher scores reflect more interpersonal problems | Baseline and through study completion, about 15 months | 
| Group Environment Scale Form R | Measured 10 group process subscales (e.g., Cohesiveness, Leader Support, Order/Organization, Expressiveness, Anger/Aggression), each with a mean scale score for 4 items rated on a 0-4 scale. | Baseline and through study completion, about 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol use disorder, women, female specific therapy, cognitive behavior therapy, group therapy