- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01318538
Women's Recovery Group (WRG) Study - A Randomized Controlled Stage II Trial
Recovery Group for Women With Substance Use Disorders - Stage II Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Belmont, Massachusetts, United States, 02478
- McLean Hospital
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Fall River, Massachusetts, United States, 02720
- Stanley Street Treatment and Resources (SSTAR)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Women's Recovery Group
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 use disorder 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.
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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 use disorder 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.
Other Names:
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Active Comparator: mixed-gender Group Drug Counseling
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 including alcohol; 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.
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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 including alcohol; 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Mean Days of Any Substance Use for Women
Time Frame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
|
This represents the percent change from baseline in the mean number of days per month of any substance use (i.e.
drug and/or alcohol) for women.
Days of substance use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months.
The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9.
The in-treatment and 2 post-treatment phases were compared to baseline data of mean days of any substance use.
Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).
The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.
|
In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
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Change in Mean ASI Alcohol Composite Score for Women
Time Frame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
|
This represents the change from baseline in mean ASI Alcohol composite scores. The ASI was administered at baseline, at months 1-6, and then at month 9. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline ASI data. Outcomes were analyzed using linear mixed effect models. These models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status. Composite scores range from 0 to 1, with higher scores indicating more significant problems. |
In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
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Change in Mean ASI Drug Composite Score for Women
Time Frame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
|
This represents the change from baseline in mean ASI Drug composite scores. The ASI was administered at baseline, at months 1-6, and then at month 9. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline ASI data. Outcomes were analyzed using linear mixed effect models. These models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status. Composite scores range from 0 to 1, with higher scores indicating more significant problems. |
In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Mean Alcohol Use Days for Women
Time Frame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
|
This represents the percent change from baseline in the mean number of alcohol use days.
Days of alcohol use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months.
The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9.
The in-treatment and 2 post-treatment phases were compared to baseline alcohol use data.
Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).
The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.
|
In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
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Percent Change in Mean Drug Use Days for Women
Time Frame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
|
This represents the percent change from baseline in the mean number of drug use days (excluding alcohol) for women.
Days of drug use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months.
The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9.
The in-treatment and 2 post-treatment phases were compared to baseline data of mean drug use days.
Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).
The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.
|
In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
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Percent Change in Mean Heavy Drinking Days for Women
Time Frame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
|
This represents the percent change from baseline in the mean number of heavy drinking days for women.
Number of heavy drinking days was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months.
The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9.
The in-treatment and 2 post-treatment phases were compared to baseline data of mean heavy drinking days.
Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).
The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.
|
In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
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Change in Mean Drinks Per Drinking Day for Women
Time Frame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
|
This represents the change from baseline in the mean number of drinks per drinking day.
Drinks per drinking day was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months.
The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9.
The in-treatment and 2 post-treatment phases were compared to baseline data of mean drinks per drinking day.
Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).
The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.
|
In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapist Adherence
Time Frame: In treatment (weeks 1-12)
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All therapists were female to eliminate any therapist-patient gender matching effects.
There were eight therapists in total: 4 who led WRG groups and 4 who led GDC groups.
All group sessions were videotaped each week so that we could measure therapist adherence to the treatment they were assigned to.
Two independent raters completed adherence scales for a random selection of 20% of WRG and 10%of GDC sessions.
For both groups, the extensiveness to which the therapist engaged in a behavior during the session was rated with a 5-point Likert scale (0 = not at all; 4 = extensively).
Adherence scores were calculated by averaging all scores for each question (25 questions for WRG; 18 for GDC) on the measure.
The scores reported here represent the average of all WRG therapists scores from all session, and all GDC therapist scores from all sessions.
Scores range from 0 to 4.
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In treatment (weeks 1-12)
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Group Attendance
Time Frame: In treatment (weeks 1-12)
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Treatment attendance was calculated by summing the number of treatment sessions attended.
Therefore, numbers range from 0-12.
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In treatment (weeks 1-12)
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Group Stability
Time Frame: In treatment (weeks 1-12)
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Treatment group stability was calculated using the Percentage of Group Change Index which captures change in group membership composition from session to session separately for each individual within each group (specific to the calendar period that each person was in the group).
The value can range from 0 (i.e., the exact same membership from one session to the next) to 1 (i.e., complete turnover in membership).
The average values across all sessions were taken to get an overall sense of the amount of turnover each person experienced in the group during the period in calendar time they were in treatment.
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In treatment (weeks 1-12)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shelly F Greenfield, MD, MPH, McLean Hospital
Publications and helpful links
General Publications
- Greenfield SF, Crisafulli MA, Kaufman JS, Freid CM, Bailey GL, Connery HS, Rapoza M, Rodolico J. Implementing substance abuse group therapy clinical trials in real-world settings: challenges and strategies for participant recruitment and therapist training in the Women's Recovery Group Study. Am J Addict. 2014 May-Jun;23(3):197-204. doi: 10.1111/j.1521-0391.2014.12099.x.
- Greenfield SF. Treating Women with Substance Use Disorders: The Women's Recovery Group Manual. New York: Guilford Press; 2016.
- Greenfield SF, Sugarman DE, Freid CM, Bailey GL, Crisafulli MA, Kaufman JS, Wigderson S, Connery HS, Rodolico J, Morgan-Lopez AA, Fitzmaurice GM. Group therapy for women with substance use disorders: results from the Women's Recovery Group Study. Drug Alcohol Depend. 2014 Sep 1;142:245-53. doi: 10.1016/j.drugalcdep.2014.06.035. Epub 2014 Jul 4.
- Sugarman DE, Wigderson SB, Iles BR, Kaufman JS, Fitzmaurice GM, Hilario EY, Robbins MS, Greenfield SF. Measuring affiliation in group therapy for substance use disorders in the Women's Recovery Group study: Does it matter whether the group is all-women or mixed-gender? Am J Addict. 2016 Oct;25(7):573-80. doi: 10.1111/ajad.12443. Epub 2016 Sep 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA - 5R01DA015434-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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