Clinical trial NCT00734903: Women Veterans' Substance Abuse Treatment
Official title: A Randomized Controlled Trial on Women's Substance Abuse Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Women
Substance Use Disorders
Treatment Efficacy
Women's Health
Outcome Assessment (Health Care)
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-08-14
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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)

Primary outcomes:
measure: Addiction Severity Index Alcohol Composite
timeFrame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
measure: Addiction Severity Index Drug Composite
timeFrame: Baseline, end of treatment (3 months), and 3-month post-treatment followup
measure: Brief Addiction Monitor
timeFrame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Secondary outcomes:
measure: Addiction Severity Index Medical Composite Score
timeFrame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
measure: Addiction Severity Index Employment Composite
timeFrame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
measure: Addiction Severity Index Psychiatric Composite
timeFrame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
measure: Addiction Severity Index Family/Social Composite
timeFrame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
measure: Global Severity Index of the Brief Symptom Inventory
timeFrame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
measure: BASIS-24 Psychosocial Functioning
timeFrame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
measure: Coping Skills Measure
timeFrame: Baseline, end of treatment, 3-month post-treatment follow-up
measure: Alcoholics Anonymous (AA) Intention Measure
timeFrame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
state: Massachusetts
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Lisa M. Najavits, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Najavits LM, Enggasser J, Brief D, Federman E. A randomized controlled trial of a gender-focused addiction model versus 12-step facilitation for women veterans. Am J Addict. 2018 Apr;27(3):210-216. doi: 10.1111/ajad.12709.