The Women's Recovery Group Study: Stage I Trial

Mass General Brigham

Status and phase: Completed; Phase 1

Conditions: Substance-Related Disorders; Alcohol-Related Disorders

Treatments: Behavioral: The Women's Recovery Group; Behavioral: mixed-gender Group Drug Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00230100

NIDA-15434-1

R01DA015434 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study was to develop a gender-specific 12-session, manual-based relapse prevention group for women with substance use disorders (SUDs).

Full description

This Phase I trial compares single-gender Women's Recovery Group (WRG) and an effective control condition, mixed-gender Group Drug Counseling (GDC). WRG is a new 12-session women-focused, manual-based relapse-prevention group therapy that uses a cognitive-behavioral approach. It is a 90-minute structured relapse prevention weekly group therapy with both women-focused content as well as an all-women group composition. The control condition, Group Drug Counseling (GDC), consists of 12 weekly 90-minute structured sessions and is conducted in a mixed-gender group composition and has no women-focused content. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community. Both groups stress abstinence. Women are randomly assigned to one of the two conditions and the groups are conducted in a rolling group, semi-open format.

The treatment manual for a Women's Recovery Group (WRG) focused on the themes that are relevant to women with SUDs. There was an emphasis on educating patients about treatment and relapse prevention in a context that is relevant to women. The manual combined therapist information and instructions with patient worksheets, handouts and skills practices. The treatment intervention was conducted twice in a pre-pilot study led by study investigators. The investigators then conducted a pilot study in which outcomes among subjects receiving the treatment intervention were compared with outcomes of subjects who received the standard mixed-gender Group Drug Counseling (GDC), chosen to approximate treatment in the community.

The study hypothesis was that the single-gender group composition and women-focused group content would result in better treatment outcomes, including decrease number of days of substance use compared with baseline during follow-up, reduced substance use, and lengthened time to relapse, compared with the mixed-gender control.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

Participants were included in the study if they:

• were diagnosed with at least one substance dependence other than nicotine dependence based on the Structured Clinical Interview for DSM-IV at the time of enrollment
• used substances within 60 days of baseline assessment
• were 18 years of age or older
• expressed intention to remain within the geographic area to return for follow-up assessments
• signed permission for the research team to communicate with any other mental health professional from whom they were receiving care

Patients were excluded if they:

• had certain co-occurring diagnoses (i.e., bipolar, post-traumatic stress, or psychotic disorders) at the time of enrollment
• were mandated to treatment
• were in residential treatment restricting substance use during the group treatment phase
• participated in concurrent substance abuse treatment group (not including self-help) during the 12-week group treatment phase
• showed clinical indication for medical detoxification (these patients were eligible to enter the study after detoxification)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Women's Recovery Group

Experimental group

Description:

The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.

Treatment:

Behavioral: The Women's Recovery Group

mixed-gender Group Drug Counseling

Active Comparator group

Description:

Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.

Treatment:

Behavioral: mixed-gender Group Drug Counseling