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

February 22, 2011
May 11, 2011
August 2008
August 2011   (final data collection date for primary outcome measure)
Change in substance use [ Time Frame: Change from baseline at end of treatment and 6 months post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01318538 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Recovery Group for Women With Substance Use Disorders
Recovery Group for Women With Substance Use Disorders

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Substance-Related Disorders
  • Alcohol-Related Disorders
  • Behavior Therapy
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: Women's Recovery Group
    Intervention: Behavioral: group treatment for substance use disorders
  • Active Comparator: mixed-gender Group Drug Counseling
    Intervention: Behavioral: group treatment for substance use disorders
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
135
June 2012
August 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01318538
NIDA - 5R01DA015434-05
No
Shelly Greenfield, MD, MPH, Chief Academic Officer, Director, Clinical Research and Education, ADATP, Professor of Psychiatry, McLean Hospital, Harvard Medical School
Mclean Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Shelly F Greenfield, MD, MPH Mclean Hospital
Mclean Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP