N/A
Completed N=166
Women's Recovery Group (WRG) Study - A Randomized Controlled Stage II Trial
Substance-Related Disorders · Alcohol-Related Disorders
Source: ClinicalTrials.gov NCT01318538 ↗
Enrolled (actual)
166
Serious AEs
10.8%
Results posted
Mar 2017
Primary outcomePrimary: Percent Change in Mean Days of Any Substance Use for Women — -76.5; -76.5; -68.4; -73.3 % change in mean substance use days — p=0.821
Summary
The purpose of this Stage II randomized controlled behavioral treatment development trial was to test the effectiveness of the Women's Recovery Group (WRG) relative to mixed-gender Group Drug Counseling (GDC) and demonstrate the feasibility of implementing the WRG in an open-enrollment (i.e., rolling admission) group format at two clinical sites. The Stage II trial aims were to (1) investigate effectiveness of the WRG relative to GDC in a sample of women heterogeneous with respect to substance use and co-occurring psychiatric disorders, and (2) demonstrate the feasibility of implementing WRG in an open enrollment group format characteristic of community treatment programs at two sites.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Mean Days of Any Substance Use for Women |
-76.5; -76.5; -68.4; -73.3; -62.2; -70.8 | 0.821 |
| PRIMARY Change in Mean ASI Alcohol Composite Score for Women |
-0.27; -0.33; -0.28; -0.36; -0.30; -0.35 | 0.253 |
| PRIMARY Change in Mean ASI Drug Composite Score for Women |
-0.03; -0.03; -0.03; -0.03; -0.02; -0.04 | 0.667 |
| SECONDARY Percent Change in Mean Alcohol Use Days for Women |
-80.6; -82.6; -70.3; -80.5; -67.8; -80.4 | 0.519 |
| SECONDARY Percent Change in Mean Drug Use Days for Women |
-66.3; -40.8; -76.7; -51.1; -62.2; -41.9 | 0.464 |
| SECONDARY Percent Change in Mean Heavy Drinking Days for Women |
-89.6; -85.7; -82.4; -82.0; -83.8; -83.2 | 0.904 |
| SECONDARY Change in Mean Drinks Per Drinking Day for Women |
-1.96; -2.87; -1.47; -1.41; -1.22; -0.76 | 0.799 |
Eligibility Criteria
Inclusion Criteria
- Subjects were included in the study if they:
- were 18 years or older
- used substances within the past 60 days
- met current Diagnostic and Statistical Manual (DSM)-IV criteria (American Psychiatric Association, 2000; World Health Organization, 1997) of substance dependence (in addition to any nicotine dependence)
- planned to stay within the area during the study period
- consented for study personnel to communicate with other mental health professionals from whom they are receiving care
- furnished the names of two locators who can assist study personnel in locating them during the study period
- were interested in group treatment
- lived close enough either to McLean Hospital or SSTAR to come to group weekly
- were able to sign informed consent.
Exclusion Criteria
- Patients were excluded if they:
- had a current medical condition that would prevent regular group attendance
- had mental retardation or organic mental disorder
- had certain other major Axis I psychiatric disorders according to the Composite International Diagnostic Interview (CIDI), such as psychotic disorders or bipolar I disorder
- would be in a residential treatment setting throughout the treatment period in which substance use is monitored and restricted (e.g., a therapeutic community)
- required medical detoxification (these patients could enter the study after being detoxified)
- were current intravenous drug users
- engaged in 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)
Data sourced from ClinicalTrials.gov (NCT01318538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.