Women Veterans' Substance Abuse Treatment

Substance Use Disorders Clinical Trial

Official title:

A Randomized Controlled Trial on Women's Substance Abuse Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734903
• Other study ID #: NEUA-001-08S
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: March 2015

Study information

• Verified date: February 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• A Woman's Path to 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.
• 12-Step Facilitation
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.

Locations

Country	Name	City	State
United States	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA	Bedford	Massachusetts
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Addiction Severity Index Medical Composite Score	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
Secondary	Addiction Severity Index Employment Composite	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
Secondary	Addiction Severity Index Psychiatric Composite	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
Secondary	Addiction Severity Index Family/Social Composite	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
Secondary	Global Severity Index of the Brief Symptom Inventory	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.	Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Secondary	BASIS-24 Psychosocial Functioning	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.	Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Secondary	Coping Skills Measure	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
Secondary	Alcoholics Anonymous (AA) Intention Measure	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.	Baseline, end of treatment (month 3), 3-month post-treatment follow-up