Overview

This trial is active, not recruiting.

Conditions substance-related disorders, alcohol-related disorders, behavior therapy
Treatment group treatment for substance use disorders
Phase phase 2
Sponsor Mclean Hospital
Collaborator National Institute on Drug Abuse (NIDA)
Start date August 2008
End date August 2011
Trial size 135 participants
Trial identifier NCT01318538, NIDA - 5R01DA015434-05

Summary

The purpose of this study is to conduct a randomized controlled Stage II trial of the Women's Recovery Group (WRG) in a larger, more diverse sample of women than characterized that of the investigators' Stage I trial. The current study is being conducted at two sites. The investigators will compare 12 weekly sessions in an open-enrollment format of the women-focused, single-gender WRG versus an equivalent amount of the active comparison treatment, mixed-gender Group Drug Counseling (GDC). In addition to testing the efficacy of the WRG, the investigators' second aim will be to investigate a priori hypotheses regarding potential moderators (e.g., psychiatric severity, self-efficacy) and mediators (e.g., engagement in ancillary treatment and community support) of treatment outcome. Finally, the investigators will conduct exploratory analyses of group process characteristics of the WRG identified during the Stage I trial and explore differences in group process between single-gender WRG and mixed-gender GDC groups.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
group treatment for substance use disorders
This two-site clinical 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. Both groups stress abstinence. Women are randomly assigned to one of the two conditions and the groups are conducted in a rolling group, open format at two sites, McLean Hospital in Belmont, MA and SSTAR in Fall River, MA.
(Active Comparator)
group treatment for substance use disorders
This two-site clinical 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. Both groups stress abstinence. Women are randomly assigned to one of the two conditions and the groups are conducted in a rolling group, open format at two sites, McLean Hospital in Belmont, MA and SSTAR in Fall River, MA.

Primary Outcomes

Measure
Change in substance use
time frame: Change from baseline at end of treatment and 6 months post-treatment

Secondary Outcomes

Measure
Psychiatric Severity
time frame: Duration of the study (9 months)
Self-efficacy
time frame: Duration of the study (9 months)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subjects will be included in the study if they are - age 18 years or older - meet current DSM-IV criteria (American Psychiatric Association, 2000; World Health Organization, 1997) of substance dependence - plan to stay within the area during the study period - consent for study personnel to communicate with other mental health professionals from whom they are receiving care - furnish the names of two locators who can assist study personnel in locating them during the study period - are interested in group treatment - live close enough either to McLean Hospital or SSTAR to come to group weekly - are able to sign informed consent. Exclusion Criteria: - Patients will be excluded if they - have a current medical condition that would prevent regular group attendance *have mental retardation or organic mental disorder - have certain other major Axis I psychiatric disorders according to the CIDI (World Health Organization, 1997) such as psychotic disorders or bipolar I disorder that are more likely to respond to another form of treatment (Mueser, Noordsy, Drake, Fox, & Barlow, 2003; Weiss RD et al., 2007) - will be in residential treatment setting throughout the treatment period in which substance use is monitored and restricted (e.g., a therapeutic community), since the intensive treatment in that setting and the restricted access to drugs could represent an important confounding variable - currently require medical detoxification (these patients may enter the study after being detoxified) - are current intravenous drug users - manifest self-destructive behaviors (e.g., life-threatening bulimia or anorexia, suicide attempts and chronic suicidality) or other behaviors (e.g., violence toward others, assault behaviors) that would interfere with group participation and would best be treated by other therapeutic modalities (e.g., DBT for parasuicidal behaviors).

Additional Information

Official title Recovery Group for Women With Substance Use Disorders
Principal investigator Shelly F Greenfield, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Mclean Hospital.