Clinical trial NCT00230100: The Women's Recovery Group Study: Stage I Trial
Official title: Recovery Group for Women With Substance Use Disorders - Stage I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol-Related Disorders
Substance-Related Disorders
Keywords: Gender differences
Women
Substance use disorders
Alcohol use disorders
Treatment outcomes
Group therapy
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

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)

Primary outcomes:
measure: Change in Mean Days of Any Substance Use for Women
timeFrame: In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)
measure: Change in Mean Number of Drinking Days for Women
timeFrame: In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)
Secondary outcomes:
measure: Change in Mean Number of Drinks Per Drinking Day for Women
timeFrame: In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)
measure: Change in Mean Addiction Severity Index Alcohol Composite Score for Women
timeFrame: In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)
Other outcomes:
measure: Baseline Substance Use Data for Women
timeFrame: Baseline
measure: Baseline Drinks Per Drinking Day for Women
timeFrame: Baseline
measure: Baseline Addiction Severity Index Alcohol Composite Score for Women
timeFrame: Baseline
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Shelly F Greenfield, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenfield SF, Trucco EM, McHugh RK, Lincoln M, Gallop RJ. The Women's Recovery Group Study: a Stage I trial of women-focused group therapy for substance use disorders versus mixed-gender group drug counseling. Drug Alcohol Depend. 2007 Sep 6;90(1):39-47. doi: 10.1016/j.drugalcdep.2007.02.009. Epub 2007 Apr 18.
citation: Greenfield SF, Potter JS, Lincoln MF, Popuch RE, Kuper L, Gallop RJ. High psychiatric symptom severity is a moderator of substance abuse treatment outcomes among women in single vs. mixed gender group treatment. Am J Drug Alcohol Abuse. 2008;34(5):594-602. doi: 10.1080/00952990802304980.
citation: McHugh RK, Greenfield SF. Psychiatric Symptom Improvement in Women Following Group Substance Abuse Treatment: Results from the Women's Recovery Group Study. J Cogn Psychother. 2010 Apr 1;24(1):26-36. doi: 10.1891/0889-8391.24.1.26.
citation: Cummings AM, Gallop RJ, Greenfield SF. Self-efficacy and substance use outcomes for women in single gender versus mixed-gender group treatment. J Groups Addict Recover. 2010;5(1):4-16. doi: 10.1080/15560350903543915.
citation: Kuper LE, Gallop R, Greenfield SF. Changes in coping moderate substance abuse outcomes differentially across behavioral treatment modality. Am J Addict. 2010 Nov-Dec;19(6):543-9. doi: 10.1111/j.1521-0391.2010.00074.x. Epub 2010 Sep 23.
citation: Greenfield SF, Cummings AM, Kuper LE, Wigderson SB, Koro-Ljungberg M. A qualitative analysis of women's experiences in single-gender versus mixed-gender substance abuse group therapy. Subst Use Misuse. 2013 Jun;48(9):750-60. doi: 10.3109/10826084.2013.787100. Epub 2013 Apr 22.
citation: Greenfield SF, Kuper LE, Cummings AM, Robbins MS, Gallop RJ. Group Process in the single-gender Women's Recovery Group compared with mixed-gender Group Drug Counseling. J Groups Addict Recover. 2013;8(4):10.1080/1556035X.2013.836867. doi: 10.1080/1556035X.2013.836867.