Testing CBT Models and Change Mechanisms for Alcohol Dependent Women

NCT ID: NCT03589274

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-01
• Study Completion Date: 2014-04-28

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I-FS-CBT

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.

Group Type: EXPERIMENTAL

I-FS-CBT

Intervention Type: BEHAVIORAL

12 manual-guided sessions of I-FS-CBT

G-FS-CBT

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.

Group Type: EXPERIMENTAL

G-FS-CBT

Intervention Type: BEHAVIORAL

12 manual-guided sessions of G-FS-CBT

Interventions

I-FS-CBT

12 manual-guided sessions of I-FS-CBT

Intervention Type: BEHAVIORAL

G-FS-CBT

12 manual-guided sessions of G-FS-CBT

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Epstein, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth E Epstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Other Identifiers

03-346R08x

Identifier Type: -

Identifier Source: org_study_id