Group Therapy for Women Recovering From Alcohol and Drug Abuse - 1

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The purpose of this study was to develop a 12-session, manual-based relapse prevention group for women with substance use disorders (SUDs). The treatment manual for a Women's Recovery Group (WRG) focused on the themes that are relevant to women with SUDs. There was an emphasis on educating patients about treatment and relapse prevention in a context that is relevant to women. The manual combined...

Brief Summary

Official Title: “Recovery Group for Women With Substance Use Disorders”

The purpose of this study was to develop a 12-session, manual-based relapse prevention group for women with substance use disorders (SUDs). The treatment manual for a Women's Recovery Group (WRG) focused on the themes that are relevant to women with SUDs. There was an emphasis on educating patients about treatment and relapse prevention in a context that is relevant to women. The manual combined therapist information and instructions with patient worksheets, handouts and homework assignments. The treatment intervention was conducted twice in a pre-pilot study led by study investigators. The investigators then conducted a pilot study in which outcomes among subjects receiving the treatment intervention were compared with outcomes of subjects who received the standard mixed-gender Group Drug Counseling (GDC). The study hypothesis was that the treatment intervention, when fully developed, would reduce substance use and lengthen time to relapse in this population of women.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: October 2005

Intervention(s) in this Clinical Trial

  • Behavioral: group treatment for substance use disorders
    • Subjects receiving the Women's Recovery Group therapy attended 12 sessions, 90 minutes each, focused on themes that are relevant to women with Substance Use Disorders. Subjects receiving the standard Group Drug Counseling in a mixed-gender group attended 12 sessions, 90 minutes each, focused on recovery principles for alcohol and drug recovery.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Women's Recovery Group
  • Active Comparator: mixed-gender Group Drug Counseling

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in substance use
    • Time Frame: Change from baseline at end of treatment and 6 months post-treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion criteria:

  • current dependence diagnosis of at least one substance dependence other than nicotine dependence based on the Structured Clinical Interview for DSM-IV
  • substance use within 60 days of baseline assessment
  • 18 years of age or older
  • 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

Exclusion criteria:

  • certain current co-occurring diagnoses (i.e., bipolar, post-traumatic stress, or psychotic disorders)
  • mandated to treatment
  • residential treatment restricting substance use during the group treatment phase
  • concurrent substance abuse treatment group (not including self-help) during the 12-week group treatment phase
  • clinical indication for medical detoxification (these patients were eligible to enter the study after detoxification)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Mclean Hospital Other

Overall Clinical Trial Officials and Contacts

Shelly F Greenfield, M.D., M.P.H. Principal Investigator Mclean Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00230100

Study ID Number: NIDA-15434-1

ClinicalTrials.gov Identifier: NCT00230100

Health Authority: United States: Federal Government

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00230100