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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Woman's Path to Recovery (WPR) | Experimental | A gender-focused approach to addiction recovery |
|
| 12-Step Facilitation (TSF) | Active Comparator | An evidence-based, non-gender-focused approach to addiction recovery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M. Najavits, PhD | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA | Bedford | Massachusetts | 02459 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29596724 | Derived | 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. |
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Of 103 screened, 82 were eligible, 21 ineligible. Of 82 eligible, 66 completed baseline and were randomized; 16 did not complete baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | A Woman's Path to Recovery (WPR) | A gender-focused approach to addiction recovery |
| FG001 | 12-Step Facilitation (TSF) | An evidence-based, non-gender-focused approach to addiction recovery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A Woman's Path to Recovery (WPR) | A gender-focused approach to addiction recovery |
| BG001 | 12-Step Facilitation (TSF) | An evidence-based, non-gender-focused approach to addiction recovery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, end of treatment (month 3), 3-month post-treatment follow-up |
|
The full study period from each participant's randomization through 3-month followup.
All serious adverse events reported were unrelated to the study and to the study treatments, as determined by our Institutional Review Board (IRB). Adverse events were monitored / reported only in terms of whether they were related or non-related to the study treatments, and not based on specific adverse event terms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A Woman's Path to Recovery (WPR) | A gender-focused approach to addiction recovery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| adverse events | Investigations | Non-systematic Assessment | All were determined to be unrelated to the study and study treatments, per the IRB of record. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Najavits, PhD | VA BOSTON | 617-299-1620 | lisa.najavits@va.gov; najavits@bu.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| 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. |
|
| Baseline, end of treatment (month 3), 3-month post-treatment follow-up |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA |
| Boston |
| Massachusetts |
| 02130 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| 12-Step Facilitation (TSF) |
An evidence-based, non-gender-focused approach to addiction recovery |
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 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 | Posted | Mean | Standard Deviation | days out of past 30 days | 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). | Posted | Mean | Standard Deviation | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, end of treatment (month 3), 3-month post-treatment follow-up |
|
|
|
| 4 |
| 33 |
| 0 |
| 33 |
| EG001 | 12-Step Facilitation (TSF) | An evidence-based, non-gender-focused approach to addiction recovery | 7 | 33 | 0 | 33 |
|
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