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Women Veterans' Substance Abuse Treatment

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A Woman's Path to Recovery
12-Step Facilitation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Women, Substance Use Disorders, Treatment Efficacy, Women's Health, Outcome Assessment (Health Care)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A Woman's Path to Recovery (WPR)

12-Step Facilitation (TSF)

Arm Description

A gender-focused approach to addiction recovery

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

Outcomes

Primary Outcome Measures

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).
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).
Brief Addiction Monitor
Assesses number of days in the past 30 days that person used substances including alcohol and drugs

Secondary Outcome Measures

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).
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).
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).
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).
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.
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.
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).
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.

Full Information

First Posted
August 12, 2008
Last Updated
February 28, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00734903
Brief Title
Women Veterans' Substance Abuse Treatment
Official Title
A Randomized Controlled Trial on Women's Substance Abuse Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Women, Substance Use Disorders, Treatment Efficacy, Women's Health, Outcome Assessment (Health Care)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A Woman's Path to Recovery (WPR)
Arm Type
Experimental
Arm Description
A gender-focused approach to addiction recovery
Arm Title
12-Step Facilitation (TSF)
Arm Type
Active Comparator
Arm Description
An evidence-based, non-gender-focused approach to addiction recovery
Intervention Type
Behavioral
Intervention Name(s)
A Woman's Path to Recovery
Other Intervention Name(s)
A Woman's Addiction Workbook
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
12-Step Facilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Addiction Severity Index Alcohol Composite
Description
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).
Time Frame
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Title
Addiction Severity Index Drug Composite
Description
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).
Time Frame
Baseline, end of treatment (3 months), and 3-month post-treatment followup
Title
Brief Addiction Monitor
Description
Assesses number of days in the past 30 days that person used substances including alcohol and drugs
Time Frame
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Secondary Outcome Measure Information:
Title
Addiction Severity Index Medical Composite Score
Description
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).
Time Frame
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Title
Addiction Severity Index Employment Composite
Description
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).
Time Frame
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Title
Addiction Severity Index Psychiatric Composite
Description
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).
Time Frame
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Title
Addiction Severity Index Family/Social Composite
Description
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).
Time Frame
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Title
Global Severity Index of the Brief Symptom Inventory
Description
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.
Time Frame
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Title
BASIS-24 Psychosocial Functioning
Description
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.
Time Frame
Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Title
Coping Skills Measure
Description
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).
Time Frame
Baseline, end of treatment, 3-month post-treatment follow-up
Title
Alcoholics Anonymous (AA) Intention Measure
Description
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.
Time Frame
Baseline, end of treatment (month 3), 3-month post-treatment follow-up

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M. Najavits, PhD
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29596724
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.
Results Reference
derived

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Women Veterans' Substance Abuse Treatment

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