The Women's Recovery Group Study: Stage I Trial

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).

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.

Eligibility 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)