Women Veterans' Substance Abuse Treatment

NCT00734903 | Completed Results DMC

• 1 other identifier: NEUA-001-08S
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Use Disorders

Keywords

Women; Substance Use Disorders; Treatment Efficacy; Women's Health; Outcome Assessment (Health Care)

Outcome Measures

Primary Outcomes (3)

• Addiction Severity Index Alcohol Composite

  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

  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

  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 Outcomes (8)

• Addiction Severity Index Medical Composite Score

  Baseline, end of treatment (month 3), 3-month post-treatment follow-up

• Addiction Severity Index Employment Composite

  Baseline, end of treatment (month 3), 3-month post-treatment follow-up

• Addiction Severity Index Psychiatric Composite

  Baseline, end of treatment (month 3), 3-month post-treatment follow-up

• Addiction Severity Index Family/Social Composite

  Baseline, end of treatment (month 3), 3-month post-treatment follow-up

• Global Severity Index of the Brief Symptom Inventory

  Baseline, end of treatment (month 3), 3-month post-treatment follow-up

Study Arms (2)

A Woman's Path to Recovery (WPR)

EXPERIMENTAL

A gender-focused approach to addiction recovery

Behavioral: A Woman's Path to Recovery

12-Step Facilitation (TSF)

ACTIVE COMPARATOR

An evidence-based, non-gender-focused approach to addiction recovery

Behavioral: 12-Step Facilitation

Interventions

A Woman's Path to Recovery BEHAVIORAL

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.

Also known as: A Woman's Addiction Workbook

A Woman's Path to Recovery (WPR)

12-Step Facilitation BEHAVIORAL

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.

12-Step Facilitation (TSF)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female Veteran
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 02459, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

• 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.

  PMID: 29596724 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Lisa Najavits, PhD
• Organization: VA BOSTON

lisa.najavits@va.gov; najavits@bu.edu

617-299-1620

Study Officials

• Lisa M. Najavits, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: October 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)