Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Women's Recovery Group (WRG) Study - A Randomized Controlled Stage II 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:
NCT01318538
First received: February 22, 2011
Last updated: February 7, 2017
Last verified: February 2017
Results First Received: December 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Substance-Related Disorders
Alcohol-Related Disorders
Interventions: Behavioral: The Women's Recovery Group
Behavioral: Group Drug Counseling

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at McLean Hospital in Belmont, MA and SSTAR Inc. in Fall River, MA using advertisements, flyers, and clinician referrals. At both sites, subjects were recruited from inpatient, residential, partial hospital and outpatient programs. Those recruited from inpatient or residential settings started the groups after discharge.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Group therapists provided feedback about the groups that they ran, but were not technically enrolled in the study and therefore are not included in initial enrollment number.

Reporting Groups
  Description
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.
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.
Group Therapist Therapists who ran and led the group sessions for both the single-gender Women's Recovery Group and mixed-gender Group Drug Counseling.

Participant Flow:   Overall Study
    Women's Recovery Group   Mixed-gender Group Drug Counseling   Group Therapist
STARTED   52   106   8 
COMPLETED   52   106   8 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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. NOTE: Baseline characteristics reported in Table Below reflect all participants including men assigned to the GDC condition. Analysis of data for study specific aims include only women randomized to WRG (N=52) and GDC (N=48).
Total Total of all reporting groups

Baseline Measures
   Women's Recovery Group   Mixed-gender Group Drug Counseling   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   106   158 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.7  (12.6)   47.6  (12.0)   47  (12.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      52 100.0%      48  45.3%      100  63.3% 
Male      0   0.0%      58  54.7%      58  36.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      1   0.9%      1   0.6% 
Not Hispanic or Latino      52 100.0%      105  99.1%      157  99.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   1.9%      0   0.0%      1   0.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   5.8%      5   4.7%      8   5.1% 
White      48  92.3%      101  95.3%      149  94.3% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Marital Status 
[Units: Participants]
     
Married   19   41   60 
Divorced/Separated   17   27   44 
Never married   12   30   42 
Unmarried and living with partner   4   5   9 
Widowed   0   3   3 
Education 
[Units: Participants]
     
Did not graduate high school   4   7   11 
Graduated high school   7   22   29 
Some college   11   22   33 
Graduated from college   18   34   52 
Postgraduate   12   21   33 
Household Income 
[Units: Participants]
     
$0-$20,000   17   26   43 
$20,001-$50,000   9   31   40 
$50,001-$100,000   11   28   39 
More than $100,000   15   21   36 
Current psychiatric diagnoses 
[Units: Participants]
     
Major depressive disorder   30   58   88 
Generalized anxiety disorder   11   20   31 
Post-traumatic stress disorder   9   20   29 
Any Axis I   37   79   116 
Any Axis II   9   15   24 
Substance use diagnoses 
[Units: Participants]
     
Alcohol current   43   97   140 
Alcohol lifetime   45   101   146 
Cocaine current   8   20   28 
Cocaine lifetime   17   40   57 
Cannabis current   3   16   19 
Cannabis lifetime   7   27   34 
Opioids current   7   19   26 
Opioids lifetime   13   27   40 
Sedatives current   5   11   16 
Sedatives lifetime   5   17   22 
Substance use days (past 30 days) 
[Units: Days]
Mean (Standard Deviation)
     
Alcohol use days   12.7  (9.9)   15.4  (10.5)   14.6  (10.3) 
Days of any substance use (including alcohol)   16.5  (9.3)   17.8  (9.8)   17.3  (9.6) 
Drug use days (excluding alcohol)   4.8  (9.2)   4.8  (9.0)   4.8  (9.0) 
Primary substance use days   13.4  (9.9)   15.7  (10.4)   14.9  (10.3) 
Heavy drinking days   9.8  (9.7)   13.5  (10.6)   12.3  (10.6) 
Drinks per drinking day   7.0  (5.0)   11.3  (7.1)   10.0  (6.8) 
Controlled environment days   0.38  (1.6)   0.26  (1.3)   .30  (1.4) 
Addiction Severity Index (ASI) composite scores [1] 
[Units: Units on a scale from 0-1]
Mean (Standard Deviation)
     
Alcohol   0.47  (0.33)   0.55  (0.29)   0.52  (0.30) 
Drug   0.07  (0.11)   0.08  (0.15)   0.08  (0.13) 
Medical   0.18  (0.24)   0.18  (0.27)   0.18  (0.26) 
Psychiatric   0.25  (0.20)   0.19  (0.19)   0.21  (0.19) 
Legal   0.04  (0.11)   0.09  (0.68)   0.07  (0.56) 
Family   0.29  (0.55)   0.24  (0.28)   0.26  (0.39) 
Employment   0.42  (0.24)   0.43  (0.29)   0.43  (0.27) 
[1] The Addiction Severity Index (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.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   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) ]

7.  Secondary:   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) ]

8.  Other Pre-specified:   Therapist Adherence   [ Time Frame: In treatment (weeks 1-12) ]

9.  Other Pre-specified:   Group Attendance   [ Time Frame: In treatment (weeks 1-12) ]

10.  Other Pre-specified:   Group Stability   [ Time Frame: In treatment (weeks 1-12) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • relatively small sample
  • sample was almost all white and well-educated (questionable generalizability)
  • therapists not blind to study


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Shelly F. Greenfield, MD, MPH
Organization: McLean Hospital
phone: 617-855-2241
e-mail: sgreenfield@mclean.harvard.edu


Publications of Results:
Other Publications:

Responsible Party: Shelly F. Greenfield, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01318538     History of Changes
Other Study ID Numbers: NIDA - 5R01DA015434-05
Study First Received: February 22, 2011
Results First Received: December 14, 2015
Last Updated: February 7, 2017