- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00734903
Women Veterans' Substance Abuse Treatment
February 28, 2018 updated by: VA Office of Research and Development
A Randomized Controlled Trial on Women's Substance Abuse Treatment
The purpose of this study is to examine the efficacy of a gender-focused addiction treatment model (A Woman's Path to Recovery) versus a non-gender focused addiction treatment model (12-Step Facilitation) in a sample of women Veterans with substance use disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Substance use disorder (SUD) is problem among women military Veterans, especially younger ones.
The goal of this study was to examine the efficacy a gender-focused model of SUD treatment (A Woman's Path to Recovery, WPR) compared to an evidence-based active comparator that is not gender-specific (12-Step Facilitation, 12SF), in a sample of for women Veterans.
The investigators randomized 66 women Veterans, ages 18-65, who were diagnosed with current SUD and used substances in the last 90 days.
The treatment phase was 12 weekly individual therapy sessions and all participants could also obtain treatment-as-usual (any other treatments they chose to attend).
Assessments were conducted at baseline, end of treatment and 3-month follow up.
Sample size was based on power analysis (an effect of .80 at a .05
level of significance).
The primary outcome variable was substance use, with various secondary outcomes also studied (e.g., psychosocial functioning, psychiatric symptoms, coping skills, 12-step attendance).
Urinalysis / breathalyzer (biological measures) were also included to validate substance use self-report.
The investigators hypothesized that participants in the experimental condition (WPR) would have more positive outcomes on both primary and secondary variables compared to those in the comparison condition (12SF).
The investigators also hypothesized that WPR patients would increase coping skills more and 12SF would increase 12-step attendance more, relative to the other condition.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Bedford, Massachusetts, United States, 02459
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A Woman's Path to Recovery (WPR)
A gender-focused approach to addiction recovery
|
WPR is a gender-specific therapy model for women with substance use disorder.
It uses A Woman's Addiction Workbook to provide education and coping skills.
In this trial it was conducted in 12 weekly individual sessions.
Other Names:
|
Active Comparator: 12-Step Facilitation (TSF)
An evidence-based, non-gender-focused approach to addiction recovery
|
12SF is an evidence-based therapy designed to facilitate early recovery from substance addiction.
It is an individual model consisting of 12 sessions that use the principles of 12-step groups such as Alcoholics Anonymous, and strongly emphasizes participation in those.
In this trial the model was conducted weekly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Addiction Severity Index Alcohol Composite
Time Frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Alcohol use and associated problems as measured by blinded-interviewer rated composite score.
Six questions comprise the alcohol composite, of which 4 are answered from 0-30 (number of days in past month) and 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology.
Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).
Breathalyzer was also obtained to verify self-report and was coded as positive (worst pathology, means patient was intoxicated) or negative (not pathological; patient was not intoxicated).
|
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Addiction Severity Index Drug Composite
Time Frame: Baseline, end of treatment (3 months), and 3-month post-treatment followup
|
Drug use and associated problems as measured by blinded-interviewer rated composite score.
Urinalysis/breathalyzer is also obtained to verify self-report.Drug use and associated problems as measured by blinded-interviewer rated composite score.
Eleven questions comprise the drug composite, of which 9 are answered from 0-30 (number of days in past month) and 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology.
Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).
Urinanalysis was also obtained to verify self-report and was coded as positive (worst pathology, means patient was intoxicated) or negative (not pathological; patient was not intoxicated).
|
Baseline, end of treatment (3 months), and 3-month post-treatment followup
|
Brief Addiction Monitor
Time Frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Assesses number of days in the past 30 days that person used substances including alcohol and drugs
|
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Addiction Severity Index Medical Composite Score
Time Frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Medical problems associated with substance use as measured by blinded-interviewer rated composite score.
Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology.
Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).
|
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Addiction Severity Index Employment Composite
Time Frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Employment problems associated with substance use as measured by blinded-interviewer rated composite score.
Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology.
Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).
|
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Addiction Severity Index Psychiatric Composite
Time Frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Psychiatric problems associated with substance use as measured by blinded-interviewer rated composite score.
Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology.
Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).
|
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Addiction Severity Index Family/Social Composite
Time Frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Family/social problems associated with substance use as measured by blinded-interviewer rated composite score.
Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology.
Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).
|
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Global Severity Index of the Brief Symptom Inventory
Time Frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Self-report measure of severity of general psychiatric symptoms ranging from 0 (not at all) to 4 (extremely).
The total scale score Global severity index (GSI) is the mean of all 53 items on the measures.
The mean ranges from 0 to 4, with higher indicating worse pathology.
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Baseline, end of treatment (month 3), 3-month post-treatment follow-up
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BASIS-24 Psychosocial Functioning
Time Frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
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24 items that address how patients feel before and after receiving care.
The survey measures the degree of difficulty experienced by the patient during a one-week period on a five-point scale ranging from 0 (no difficulty) to extreme difficulty (4) with the overall score ranging from 0-96.
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Baseline, end of treatment (month 3), 3-month post-treatment follow-up
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Coping Skills Measure
Time Frame: Baseline, end of treatment, 3-month post-treatment follow-up
|
Self-report measure of confidence in ability to cope comprising 18 items, each scaled from 0 (not at all) to 5 (extremely).
The mean across all 18 items ranges from 0 to 5 with higher scores indicating less pathology (i.e., stronger ability to cope).
|
Baseline, end of treatment, 3-month post-treatment follow-up
|
Alcoholics Anonymous (AA) Intention Measure
Time Frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
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Self-reported attitudes toward attending 12-step meetings; a scale of 17 items, each rated 1 (extremely unlikely) to 7 (extremely likely).
The mean across all items thus ranges from 1 to 7 with with more positive scores indicating a more positive attitude toward 12-step meetings.
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Baseline, end of treatment (month 3), 3-month post-treatment follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisa M. Najavits, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
August 12, 2008
First Submitted That Met QC Criteria
August 12, 2008
First Posted (Estimate)
August 14, 2008
Study Record Updates
Last Update Posted (Actual)
November 5, 2018
Last Update Submitted That Met QC Criteria
February 28, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEUA-001-08S
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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