Clinical trial NCT03589274: Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
Official title: Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: alcohol use disorder
women
female specific therapy
cognitive behavior therapy
group therapy
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Drinking Days (PDD)
timeFrame: Change from baseline across 15 months post-session 1
measure: Percent Heavy Drinking Days (PHDD)
timeFrame: Change from baseline across 15 months post-session 1
measure: Mean Drinks Per Drinking Day (MDPDD)
timeFrame: Change from baseline across 15 months post-session 1
Secondary outcomes:
measure: Beck Depression Inventory II
timeFrame: Baseline and through study completion, about 15 months
measure: Anxiety
timeFrame: Baseline and through study completion, about 15 months
measure: Sociotropy-Autonomy Scale
timeFrame: Baseline and through study completion, about 15 months
measure: Coping Strategies Scale
timeFrame: Baseline and through study completion, about 15 months
measure: Situational Confidence Scale 8
timeFrame: Baseline and through study completion, about 15 months
measure: Important People Inventory
timeFrame: Baseline and through study completion, about 15 months
measure: Self care
timeFrame: Baseline and through study completion, about 15 months
measure: Inventory of Personal Problems
timeFrame: Baseline and through study completion, about 15 months
measure: Group Environment Scale Form R
timeFrame: Baseline and through study completion, about 15 months
Other outcomes:
measure: End of Treatment Questionnaire
timeFrame: 3 months post session 1
measure: Working Alliance Inventory - Short Form
timeFrame: Weekly during Treatment, about 15 weeks
measure: Therapy Integrity Rating Scale
timeFrame: Weekly during treatment, about 15 weeks
measure: Therapist Checklist
timeFrame: Weekly during Treatment, about 15 weeks
Locations:
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Elizabeth E Epstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: