A Randomized Controlled Trial on Women's Substance Abuse Treatment (WPR)

This study is currently recruiting participants.
Verified December 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00734903
First received: August 12, 2008
Last updated: January 2, 2014
Last verified: December 2013
  Purpose

The purpose of this study is to examine in veterans the efficacy of an evidence-based gender-specific treatment model for women with substance use disorder (SUD).


Condition Intervention Phase
Substance Use Disorders
Behavioral: A Woman's Path to Recovery (WPR)
Behavioral: Twelve-Step Facilitation (TSF)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on Women's Substance Abuse Treatment

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Number of days abstinent from alcohol, "other substances", and "any substance" and substance use, by type and frequency using the TimeLine FollowBack (TLFB) & Addiction Severity Index (ASI) drug and alcohol composite scores, Brief Addiction Monitor [ Time Frame: Baseline, month 1 (during treatment), month 2 (during treatment), end of treatment (month 3), 3-month post-treatment follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • medical, employment, legal, family/social, and psychiatric functioning as measured by the Addiction Severity Index (ASI) composite scores [ Time Frame: Baseline, month 1 (during treatment), month 2 (during treatment), end of treatment (month 3), 3-month post-treatment follow-up ] [ Designated as safety issue: No ]
  • psychosocial functioning (ASI) [ Time Frame: Baseline, month 1 (during treatment), month 2 (during treatment), end of treatment (month 3), 3-month post-treatment follow-up ] [ Designated as safety issue: No ]
  • Use of adaptive coping skills (Coping Strategies Inventory) [ Time Frame: Baseline, end of treatment, 3-month post-treatment follow-up ] [ Designated as safety issue: No ]
  • Cognitions related to substance use (measured using Beliefs About Substance Use) [ Time Frame: Baseline, end of treatment, 3-month post-treatment follow-up ] [ Designated as safety issue: No ]
  • General mental health functioning (based on BSI subscale scores) [ Time Frame: Baseline, month 1 (during treatment), month 2 (during treatment), end of treatment (month 3), 3-month post-treatment follow-up ] [ Designated as safety issue: No ]
  • Service utilization (measured with Treatment Services Review, Service Utilization Questionnaire, and Modified Weekly Self-Help Questionnaire) [ Time Frame: Baseline, month 1 (during treatment), month 2 (during treatment), end of treatment (month 3), 3-month post-treatment follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Female participants randomly assigned to receive the experimental treatment model -- A Woman's Path to Recovery (WPR)
Behavioral: A Woman's Path to Recovery (WPR)
A Woman's Path to Recovery (WPR) is an evidence-based gender-specific treatment model for women with substance use disorder. It is a 12-session model that is conducted once per week in individual modality, with eight core sessions and four session topics that participants can select from a larger menu.
Active Comparator: Arm 2
Female participants randomly assigned to receive the active behavioral treatment control -- Twelve-Step Facilitation (TSF)
Behavioral: Twelve-Step Facilitation (TSF)
Twelve-Step Facilitation (TSF) consists of a brief, structured, and manual-driven approach to facilitating early recovery from alcohol abuse/alcoholism and other drug abuse/addiction. It is intended to be implemented on an individual basis in 12 to 15 sessions and is based in behavioral, spiritual, and cognitive principles that form the core of 12-step fellowships such as Alcoholics Anonymous (AA) and Narcotics Anonymous (NA).

Detailed Description:

Anticipated Impacts on Veterans' Healthcare: Our study will obtain important scientific and clinical knowledge about the efficacy of an evidence-based gender specific model of treatment (A Woman's Path to Recovery) for women veterans with substance use disorder (SUD), compared to an existing model that is not gender specific (12-Step Facilitation). 12-Step Facilitation focuses on encouraging attendance at 12-step groups such as Alcoholics Anonymous. If the gender-specific approach to treatment is more effective than 12-Step Facilitation for veterans with SUD in the VA, it may substantially improve the physical and mental health outcomes of women veterans, and decrease healthcare costs by providing a replicable method for delivering treatment.

Project Background: SUD is common among women veterans, and on the rise among younger women veterans. As more women veterans seek treatment at the VA, there is likely to be an increased need for evidence-based treatment of SUD. To our knowledge, the PI has developed the only gender-based treatment approach that has shown significant outcomes in a pilot trial, on multiple domains. This proposal represents an opportunity to evaluate its efficacy with women veterans, including younger OIF/OEF veterans.

Project Objectives: The goal of this proposal is to examine the efficacy of an evidence-based gender-specific model of treatment for women veterans with SUD in comparison to a control condition that is not gender-specific (12-Step Facilitation). The long-term objective is to improve treatment outcomes for women veterans with SUD through use of a gender-specific model that is designed to be sensitive to women's unique needs.

Project Methods: We plan to conduct a randomized clinical trial in which women veterans with SUD are assigned to either a gender-specific model of treatment (A Woman's Path to Recovery; WPR), or to a control condition (12-Step Facilitation; 12SF); the latter does not include gender-specific treatment. We will recruit 102 women veterans, ages 18-65, who are diagnosed with SUD and in 11/2012 the protocol was amended to have used substances in the last 90 days. In 9/2011, the protocol was amended to include patients in residential care. Their substance use 90-days prior to residential treatment will be measured for baseline data. Our target is 66 randomized patients. The treatment phase will consist of 12 weeks of weekly therapy; all participants will receive treatment-as-usual (any other treatments they choose to attend). Assessments will be conducted at baseline, Months 1 and 2, end of treatment and 3 month follow up. The study is powered to detect an effect of .80 at a .05 level of significance with this sample size. Cross-sectional, repeated measures and longitudinal analyses are proposed. The primary outcome variable is substance use, with a variety of secondary outcomes (e.g., psychosocial functioning, psychiatric symptoms, coping skills, 12-step attendance) also being explored. We will evaluate potential mechanisms of action of WPR as a secondary question of interest. Biological measures are included to validate substance use self-report of participants. We hypothesize that participants in the experimental condition (WPR) will have more positive outcomes on both primary and secondary variables, and a higher level of treatment satisfaction compared to those in the control condition (12SF) and that mediators/moderators of outcomes (i.e., mechanisms of action) will be knowledge of gender-specific substance abuse recovery concepts and use of coping skills.

  Eligibility

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

Inclusion Criteria:

  • Female veteran
  • 18-65 years of age
  • Meet DSM-IV criteria for current SUD with "current" defined as meeting SUD criteria per the DSM-IV and having used a substance within the 90 days prior to intake (to be able to accurately evaluate changes in their substance use from baseline)
  • Plan to stay in the Boston area for the next 6 months
  • Have a mailing address and live close enough to come to the hospital once weekly for treatment and/or assessment
  • Able to complete the Statement of Informed Consent
  • Willing to participate in all assessments and breathalyzer/urine testing
  • Willing to provide a release of information such that study staff can contact her other providers as needed regarding any concerns during her participation
  • Able to obtain medical clearance
  • Willing to allow us to contact family and/or friends if participant loses contact with us
  • Literate
  • Not pregnant or planning to become pregnant

Exclusion Criteria:

  • Any acute medical condition that would interfere with the participant's ability to participate in treatment, or would be of such severity as to affect the individual's psychological functioning (e.g., cancer)
  • Current bipolar I disorder, schizophrenia or other psychotic disorders or mental retardation or organic mental disorder (determined by screening interview)
  • Any clinical sign that the client is not sufficiently stable to participate in the treatment, such as client's treatment provider indicating that participation in the treatment would be contraindicated
  • Dangerousness that would present a threat to other staff or other clients (e.g., history of recent assault)
  • Client is mandated to treatment
  • Psychopharmacologic treatment that is planned to change or likely to change substantively over the 3-month active treatment phase (with "substantive" defined as any addition of a new medication or major shift in dosage)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734903

Contacts
Contact: Lisa M Najavits, PhD (617) 299-1620 Lisa.najavits@va.gov
Contact: Helen Tretiak-Carmichael, MA (857) 364-5311 Helen.Tretiak-Carmichael@va.gov

Locations
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Recruiting
Bedford, Massachusetts, United States, 01730
Contact: Helen M Tretiak-Carmichael, MA    857-364-5311    Helen.Tretiak-Carmichael@va.gov   
VA Medical Center, Jamaica Plain Campus Recruiting
Boston, Massachusetts, United States, 02130
Contact: Lisa M Najavits, PhD    617-299-1620    Lisa.najavits@va.gov   
Sub-Investigator: Justin L. Enggasser, PhD         
Principal Investigator: Lisa M. Najavits, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Lisa M. Najavits, PhD VA Medical Center, Jamaica Plain Campus
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00734903     History of Changes
Other Study ID Numbers: NEUA-001-08S
Study First Received: August 12, 2008
Last Updated: January 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Women
Substance Use Disorders
Treatment Efficacy
Women's Health
Outcome Assessment (Health Care)

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014