Women's Recovery Group (WRG) Study - A Randomized Controlled Stage II Trial

NCT01318538 | Completed Results

• 1 other identifier: NIDA - 5R01DA015434-05
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Substance-Related Disorders; Alcohol-Related Disorders

Keywords

Substance use disorders, Gender differences, women, treatment outcomes, group therapy

Outcome Measures

Primary Outcomes (3)

• Percent Change in Mean Days of Any Substance Use for Women

  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)

• Change in Mean ASI Alcohol Composite Score for Women

  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)

• Change in Mean ASI Drug Composite Score for Women

  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)

Secondary Outcomes (4)

• Percent Change in Mean Alcohol Use Days for Women

  In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

• Percent Change in Mean Drug Use Days for Women

  In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

• Percent Change in Mean Heavy Drinking Days for Women

  In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

• Change in Mean Drinks Per Drinking Day for Women

  In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

Other Outcomes (3)

• Therapist Adherence

  In treatment (weeks 1-12)

• Group Attendance

  In treatment (weeks 1-12)

• Group Stability

  In treatment (weeks 1-12)

Study Arms (2)

Women's Recovery Group

EXPERIMENTAL

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.

Behavioral: The Women's Recovery Group

mixed-gender Group Drug Counseling

ACTIVE COMPARATOR

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.

Behavioral: Group Drug Counseling

Interventions

The Women's Recovery Group BEHAVIORAL

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.

Also known as: WRG

Women's Recovery Group

Group Drug Counseling BEHAVIORAL

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.

Also known as: GDC

mixed-gender Group Drug Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Stanley Street Treatment and Resources (SSTAR)

Fall River, Massachusetts, 02720, United States

Location

Related Publications (4)

• 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.

  PMID: 24724875 BACKGROUND

• Greenfield SF. Treating Women with Substance Use Disorders: The Women's Recovery Group Manual. New York: Guilford Press; 2016.

  BACKGROUND

• 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.

  PMID: 25042759 RESULT

• 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.

  PMID: 27647710 RESULT

MeSH Terms

Conditions

Substance-Related Disorders; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

* relatively small sample * sample was almost all white and well-educated (questionable generalizability) * therapists not blind to study

Results Point of Contact

• Title: Shelly F. Greenfield, MD, MPH
• Organization: McLean Hospital

sgreenfield@mclean.harvard.edu

617-855-2241

Study Officials

• Shelly F Greenfield, MD, MPH

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Academic Officer; Chief, Division of Women's Mental Health; Kristine M Trustey Endowed Professor of Psychiatry; Director, Clinical and Health Services Research and Education, McLean Hospital; Professor of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: March 18, 2011
• Study Start: August 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: June 1, 2012
• Last Updated: June 5, 2017
• Results First Posted: March 28, 2017

Record last verified: 2017-04

Locations

US (2)