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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00230100
First received: September 29, 2005
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Alcohol-Related Disorders
Behavior Therapy
Substance-Related Disorders
 Behavioral: group treatment for substance use disorders
 Phase 1

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 ]

Enrollment: 46
Study Start Date: March 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Women's Recovery Group 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.
Active Comparator: mixed-gender Group Drug Counseling 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230100

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478 9106
Sponsors and Collaborators
Mclean Hospital
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Shelly F Greenfield, M.D., M.P.H. Mclean Hospital
  More Information

No publications provided

Responsible Party: Shelly F. Greenfield, M.D., M.P.H., Chief Academic Officer, Director, Clinical Research and Education, ADATP, Professor of Psychiatry, McLean Hospital, Harvard Medical School
ClinicalTrials.gov Identifier: NCT00230100     History of Changes
Other Study ID Numbers: NIDA-15434-1, R01DA015434
Study First Received: September 29, 2005
Last Updated: June 14, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on June 17, 2013