Recovery Group for Women With Substance Use Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Mclean Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01318538
First received: February 22, 2011
Last updated: May 11, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to conduct a randomized controlled Stage II trial of the Women's Recovery Group (WRG) in a larger, more diverse sample of women than characterized that of the investigators' Stage I trial. The current study is being conducted at two sites. The investigators will compare 12 weekly sessions in an open-enrollment format of the women-focused, single-gender WRG versus an equivalent amount of the active comparison treatment, mixed-gender Group Drug Counseling (GDC). In addition to testing the efficacy of the WRG, the investigators' second aim will be to investigate a priori hypotheses regarding potential moderators (e.g., psychiatric severity, self-efficacy) and mediators (e.g., engagement in ancillary treatment and community support) of treatment outcome. Finally, the investigators will conduct exploratory analyses of group process characteristics of the WRG identified during the Stage I trial and explore differences in group process between single-gender WRG and mixed-gender GDC groups.


Condition Intervention Phase
Substance-Related Disorders
Alcohol-Related Disorders
Behavior Therapy
Behavioral: group treatment for substance use disorders
Phase 2

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

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Change in substance use [ Time Frame: Change from baseline at end of treatment and 6 months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychiatric Severity [ Time Frame: Duration of the study (9 months) ] [ Designated as safety issue: No ]
  • Self-efficacy [ Time Frame: Duration of the study (9 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: August 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Women's Recovery Group Behavioral: group treatment for substance use disorders
This two-site clinical 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. Both groups stress abstinence. Women are randomly assigned to one of the two conditions and the groups are conducted in a rolling group, open format at two sites, McLean Hospital in Belmont, MA and SSTAR in Fall River, MA.
Active Comparator: mixed-gender Group Drug Counseling Behavioral: group treatment for substance use disorders
This two-site clinical 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. Both groups stress abstinence. Women are randomly assigned to one of the two conditions and the groups are conducted in a rolling group, open format at two sites, McLean Hospital in Belmont, MA and SSTAR in Fall River, MA.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will be included in the study if they are

    • age 18 years or older
    • meet current DSM-IV criteria (American Psychiatric Association, 2000; World Health Organization, 1997) of substance dependence
    • plan to stay within the area during the study period
    • consent for study personnel to communicate with other mental health professionals from whom they are receiving care
    • furnish the names of two locators who can assist study personnel in locating them during the study period
    • are interested in group treatment
    • live close enough either to McLean Hospital or SSTAR to come to group weekly
    • are able to sign informed consent.

Exclusion Criteria:

  • Patients will be excluded if they

    • have a current medical condition that would prevent regular group attendance *have mental retardation or organic mental disorder
    • have certain other major Axis I psychiatric disorders according to the CIDI (World Health Organization, 1997) such as psychotic disorders or bipolar I disorder that are more likely to respond to another form of treatment (Mueser, Noordsy, Drake, Fox, & Barlow, 2003; Weiss RD et al., 2007)
    • will be in residential treatment setting throughout the treatment period in which substance use is monitored and restricted (e.g., a therapeutic community), since the intensive treatment in that setting and the restricted access to drugs could represent an important confounding variable
    • currently require medical detoxification (these patients may enter the study after being detoxified)
    • are current intravenous drug users
    • manifest 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) that would interfere with group participation and would best be treated by other therapeutic modalities (e.g., DBT for parasuicidal behaviors).
  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: NCT01318538

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Stanley Street Treatment and Resources (SSTAR)
Fall River, Massachusetts, United States, 02720
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Shelly F Greenfield, MD, MPH Mclean Hospital
  More Information

No publications provided

Responsible Party: Shelly Greenfield, MD, MPH, Chief Academic Officer, Director, Clinical Research and Education, ADATP, Professor of Psychiatry, McLean Hospital, Harvard Medical School
ClinicalTrials.gov Identifier: NCT01318538     History of Changes
Other Study ID Numbers: NIDA - 5R01DA015434-05
Study First Received: February 22, 2011
Last Updated: May 11, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014