A Randomized Controlled Trial on Women's Substance Abuse Treatment (WPR)
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|ClinicalTrials.gov Identifier: NCT00734903|
Recruitment Status : Active, not recruiting
First Posted : August 14, 2008
Last Update Posted : December 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Substance Use Disorders||Behavioral: A Woman's Path to Recovery (WPR) Behavioral: Twelve-Step Facilitation (TSF)||Phase 2|
Anticipated Impacts on Veterans' Healthcare: The investigators' 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 the investigators' 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: The investigators 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. The investigators 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. The 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. The investigators 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. The investigators 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial on Women's Substance Abuse Treatment|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||January 2017|
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).
- 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 ]
- 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 ]
- 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 ]
- Use of adaptive coping skills (Coping Strategies Inventory) [ Time Frame: Baseline, end of treatment, 3-month post-treatment follow-up ]
- Cognitions related to substance use (measured using Beliefs About Substance Use) [ Time Frame: Baseline, end of treatment, 3-month post-treatment follow-up ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734903
|United States, Massachusetts|
|Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA|
|Bedford, Massachusetts, United States, 01730|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||Lisa M. Najavits, PhD||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|