NCT00230100

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
11.4 years until next milestone

Results Posted

Study results publicly available

February 8, 2017

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

September 29, 2005

Results QC Date

September 15, 2014

Last Update Submit

October 18, 2023

Conditions

Alcohol-Related DisordersSubstance-Related Disorders

Keywords

Gender differencesWomenSubstance use disordersAlcohol use disordersTreatment outcomesGroup therapy

Outcome Measures

Primary Outcomes (2)

  • Change in Mean Days of Any Substance Use for Women

    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.

    In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)

  • Change in Mean Number of Drinking Days for Women

    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.

    In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)

Secondary Outcomes (2)

  • Change in Mean Number of Drinks Per Drinking Day for Women

    In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)

  • Change in Mean Addiction Severity Index Alcohol Composite Score for Women

    In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)

Other Outcomes (3)

  • Baseline Substance Use Data for Women

    Baseline

  • Baseline Drinks Per Drinking Day for Women

    Baseline

  • Baseline Addiction Severity Index Alcohol Composite Score for Women

    Baseline

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 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

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 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

Interventions

The Women's Recovery GroupBEHAVIORAL

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.

Also known as: WRG
Women's Recovery Group
mixed-gender Group Drug CounselingBEHAVIORAL

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.

Also known as: GDC
mixed-gender Group Drug Counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478 9106, United States

Location

Related Publications (7)

  • Greenfield SF, Trucco EM, McHugh RK, Lincoln M, Gallop RJ. The Women's Recovery Group Study: a Stage I trial of women-focused group therapy for substance use disorders versus mixed-gender group drug counseling. Drug Alcohol Depend. 2007 Sep 6;90(1):39-47. doi: 10.1016/j.drugalcdep.2007.02.009. Epub 2007 Apr 18.

    PMID: 17446014RESULT

  • Greenfield SF, Potter JS, Lincoln MF, Popuch RE, Kuper L, Gallop RJ. High psychiatric symptom severity is a moderator of substance abuse treatment outcomes among women in single vs. mixed gender group treatment. Am J Drug Alcohol Abuse. 2008;34(5):594-602. doi: 10.1080/00952990802304980.

    PMID: 18821452RESULT

  • McHugh RK, Greenfield SF. Psychiatric Symptom Improvement in Women Following Group Substance Abuse Treatment: Results from the Women's Recovery Group Study. J Cogn Psychother. 2010 Apr 1;24(1):26-36. doi: 10.1891/0889-8391.24.1.26.

    PMID: 20625473RESULT

  • Cummings AM, Gallop RJ, Greenfield SF. Self-efficacy and substance use outcomes for women in single gender versus mixed-gender group treatment. J Groups Addict Recover. 2010;5(1):4-16. doi: 10.1080/15560350903543915.

    PMID: 21753920RESULT

  • Kuper LE, Gallop R, Greenfield SF. Changes in coping moderate substance abuse outcomes differentially across behavioral treatment modality. Am J Addict. 2010 Nov-Dec;19(6):543-9. doi: 10.1111/j.1521-0391.2010.00074.x. Epub 2010 Sep 23.

    PMID: 20958851RESULT

  • Greenfield SF, Cummings AM, Kuper LE, Wigderson SB, Koro-Ljungberg M. A qualitative analysis of women's experiences in single-gender versus mixed-gender substance abuse group therapy. Subst Use Misuse. 2013 Jun;48(9):750-60. doi: 10.3109/10826084.2013.787100. Epub 2013 Apr 22.

    PMID: 23607675RESULT

  • Greenfield SF, Kuper LE, Cummings AM, Robbins MS, Gallop RJ. Group Process in the single-gender Women's Recovery Group compared with mixed-gender Group Drug Counseling. J Groups Addict Recover. 2013;8(4):10.1080/1556035X.2013.836867. doi: 10.1080/1556035X.2013.836867.

    PMID: 24294145RESULT

MeSH Terms

Conditions

Alcohol-Related DisordersSubstance-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Limitations and Caveats

* small sample * small proportion had drug dependence; majority had alcohol dependence (questionable generalizability) * 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, M.D., M.P.H.

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Academic Officer, Director, Clinical Research and Education, ADATP, Professor of Psychiatry, McLean Hospital, Harvard Medical School.

Study Record Dates

First Submitted

September 29, 2005

First Posted

September 30, 2005

Study Start

March 1, 2003

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

November 1, 2023

Results First Posted

February 8, 2017

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)