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The Women's Recovery Group Study: Stage I Trial

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Shelly F. Greenfield, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00230100
First received: September 29, 2005
Last updated: December 16, 2016
Last verified: December 2016
  Purpose
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).

Condition Intervention Phase
Alcohol-Related Disorders
Substance-Related Disorders
Behavioral: The Women's Recovery Group
Behavioral: mixed-gender Group Drug Counseling
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recovery Group for Women With Substance Use Disorders - Stage I

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Change in Mean Days of Any Substance Use for Women [ Time Frame: In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) ]
    This represents the change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol). Days of substance use was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.

  • Change in Mean Number of Drinking Days for Women [ Time Frame: In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) ]
    This represents the change from baseline in the mean number of drinking days for women. Number drinking days was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.


Secondary Outcome Measures:
  • Change in Mean Number of Drinks Per Drinking Day for Women [ Time Frame: In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) ]
    This represents the change from baseline in the mean number of drinks per drinking day for women. The number of drinks per drinking day was measured using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.

  • Change in Mean Addiction Severity Index Alcohol Composite Score for Women [ Time Frame: In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) ]

    This represents the change from baseline in mean composite scores of the Addiction Severity Index (ASI) alcohol section. The ASI was administered at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.

    The ASI is a widely employed multidimensional assessment of substance-related problems. Scores range from 0-1 where higher scores reflect higher addiction severity.



Other Outcome Measures:
  • Baseline Substance Use Data for Women [ Time Frame: Baseline ]
    The data reflect baseline characteristics of women participants with respect to (1) days of any substance use (i.e. drugs or alcohol), and (2) the number of drinking days, in the 60 days prior to baseline intake.This data was collected using the Timeline Follow-Back.

  • Baseline Drinks Per Drinking Day for Women [ Time Frame: Baseline ]
    The data reflect baseline characteristics of the women participants with respect to the number of drinks per drinking day in the 60 days prior to baseline intake. This was measured using the Timeline Follow-Back.

  • Baseline Addiction Severity Index Alcohol Composite Score for Women [ Time Frame: Baseline ]
    The data reflect baseline characteristics of the participants with respect to ASI alcohol composite score. Scores range between 0 and 1. Higher scores reflect higher addiction severity. 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.


Enrollment: 46
Study Start Date: March 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 abuse 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.
Behavioral: The 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 abuse 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 Name: WRG
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 of abuse; 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.
Behavioral: 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 of abuse; 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 Name: GDC

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230100

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478 9106
Sponsors and Collaborators
Mclean Hospital
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Shelly F Greenfield, M.D., M.P.H. Mclean Hospital
  More Information

Publications:

Responsible Party: Shelly F. Greenfield, Chief Academic Officer, Director, Clinical Research and Education, ADATP, Professor of Psychiatry, McLean Hospital, Harvard Medical School., Mclean Hospital
ClinicalTrials.gov Identifier: NCT00230100     History of Changes
Other Study ID Numbers: NIDA-15434-1
R01DA015434 ( US NIH Grant/Contract Award Number )
Study First Received: September 29, 2005
Results First Received: September 15, 2014
Last Updated: December 16, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mclean Hospital:
Gender differences
Women
Substance use disorders
Alcohol use disorders
Treatment outcomes
Group therapy

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Alcohol-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 26, 2017