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Women Veterans' Substance Abuse Treatment

A Randomized Controlled Trial on Women's Substance Abuse Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00734903
Enrollment
66
Registered
2008-08-14
Start date
2010-10-31
Completion date
2015-03-31
Last updated
2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

Keywords

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

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.

Interventions

BEHAVIORALA 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.

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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Addiction Severity Index Alcohol CompositeBaseline, end of treatment (month 3), 3-month post-treatment follow-upAlcohol 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 CompositeBaseline, end of treatment (3 months), and 3-month post-treatment followupDrug 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 MonitorBaseline, end of treatment (month 3), 3-month post-treatment follow-upAssesses number of days in the past 30 days that person used substances including alcohol and drugs

Secondary

MeasureTime frameDescription
Addiction Severity Index Family/Social CompositeBaseline, end of treatment (month 3), 3-month post-treatment follow-upFamily/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 InventoryBaseline, end of treatment (month 3), 3-month post-treatment follow-upSelf-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.
Addiction Severity Index Medical Composite ScoreBaseline, end of treatment (month 3), 3-month post-treatment follow-upMedical 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).
Coping Skills MeasureBaseline, end of treatment, 3-month post-treatment follow-upSelf-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 MeasureBaseline, end of treatment (month 3), 3-month post-treatment follow-upSelf-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.
BASIS-24 Psychosocial FunctioningBaseline, end of treatment (month 3), 3-month post-treatment follow-up24 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.
Addiction Severity Index Employment CompositeBaseline, end of treatment (month 3), 3-month post-treatment follow-upEmployment 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 CompositeBaseline, end of treatment (month 3), 3-month post-treatment follow-upPsychiatric 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).

Countries

United States

Participant flow

Pre-assignment details

Of 103 screened, 82 were eligible, 21 ineligible. Of 82 eligible, 66 completed baseline and were randomized; 16 did not complete baseline.

Participants by arm

ArmCount
A Woman's Path to Recovery (WPR)
A gender-focused approach to addiction recovery
33
12-Step Facilitation (TSF)
An evidence-based, non-gender-focused approach to addiction recovery
33
Total66

Baseline characteristics

CharacteristicA Woman's Path to Recovery (WPR)Total12-Step Facilitation (TSF)
Age, Continuous46.97 years
STANDARD_DEVIATION 9.92
47.72 years
STANDARD_DEVIATION 9.01
48.45 years
STANDARD_DEVIATION 8.13
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants59 Participants30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants5 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants3 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
6 Participants12 Participants6 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants5 Participants3 Participants
Race (NIH/OMB)
White
23 Participants45 Participants22 Participants
Region of Enrollment
United States
33 Participants66 Participants33 Participants
Sex: Female, Male
Female
33 Participants66 Participants33 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 330 / 33
serious
Total, serious adverse events
4 / 337 / 33

Outcome results

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).

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

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)Addiction Severity Index Alcohol CompositeBaseline.36 units on a scaleStandard Deviation 0.24
A Woman's Path to Recovery (WPR)Addiction Severity Index Alcohol CompositeEnd of Treatment.18 units on a scaleStandard Deviation 0.21
A Woman's Path to Recovery (WPR)Addiction Severity Index Alcohol Composite3-month followup.23 units on a scaleStandard Deviation 0.19
12-Step Facilitation (TSF)Addiction Severity Index Alcohol CompositeEnd of Treatment.26 units on a scaleStandard Deviation 0.24
12-Step Facilitation (TSF)Addiction Severity Index Alcohol Composite3-month followup.21 units on a scaleStandard Deviation 0.11
12-Step Facilitation (TSF)Addiction Severity Index Alcohol CompositeBaseline.46 units on a scaleStandard Deviation 0.35
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).

Time frame: Baseline, end of treatment (3 months), and 3-month post-treatment followup

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)Addiction Severity Index Drug CompositeBaseline.10 units on a scaleStandard Deviation 0.11
A Woman's Path to Recovery (WPR)Addiction Severity Index Drug Composite3-month followup.04 units on a scaleStandard Deviation 0.05
A Woman's Path to Recovery (WPR)Addiction Severity Index Drug CompositeEnd of Treatment.04 units on a scaleStandard Deviation 0.05
12-Step Facilitation (TSF)Addiction Severity Index Drug CompositeBaseline.10 units on a scaleStandard Deviation 0.12
12-Step Facilitation (TSF)Addiction Severity Index Drug CompositeEnd of Treatment.06 units on a scaleStandard Deviation 0.06
12-Step Facilitation (TSF)Addiction Severity Index Drug Composite3-month followup.04 units on a scaleStandard Deviation 0.05
Primary

Brief Addiction Monitor

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

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)Brief Addiction MonitorBaseline4.61 days out of past 30 daysStandard Deviation 3.5
A Woman's Path to Recovery (WPR)Brief Addiction MonitorEnd of Treatment1.96 days out of past 30 daysStandard Deviation 2.08
A Woman's Path to Recovery (WPR)Brief Addiction Monitor3-month followup2.33 days out of past 30 daysStandard Deviation 1.92
12-Step Facilitation (TSF)Brief Addiction MonitorBaseline4.48 days out of past 30 daysStandard Deviation 3.85
12-Step Facilitation (TSF)Brief Addiction MonitorEnd of Treatment2.33 days out of past 30 daysStandard Deviation 3.17
12-Step Facilitation (TSF)Brief Addiction Monitor3-month followup1.92 days out of past 30 daysStandard Deviation 2.36
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).

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

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)Addiction Severity Index Employment Composite3-month followup.58 units on a scaleStandard Deviation 0.28
A Woman's Path to Recovery (WPR)Addiction Severity Index Employment CompositeBaseline.64 units on a scaleStandard Deviation 0.27
A Woman's Path to Recovery (WPR)Addiction Severity Index Employment CompositeEnd of Treatment.58 units on a scaleStandard Deviation 0.29
12-Step Facilitation (TSF)Addiction Severity Index Employment Composite3-month followup.56 units on a scaleStandard Deviation 0.32
12-Step Facilitation (TSF)Addiction Severity Index Employment CompositeBaseline.59 units on a scaleStandard Deviation 0.34
12-Step Facilitation (TSF)Addiction Severity Index Employment CompositeEnd of Treatment.54 units on a scaleStandard Deviation 0.33
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).

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

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)Addiction Severity Index Family/Social CompositeBaseline.20 units on a scaleStandard Deviation 0.21
A Woman's Path to Recovery (WPR)Addiction Severity Index Family/Social CompositeEnd of Treatment.14 units on a scaleStandard Deviation 0.15
A Woman's Path to Recovery (WPR)Addiction Severity Index Family/Social Composite3-month followup.23 units on a scaleStandard Deviation 0.23
12-Step Facilitation (TSF)Addiction Severity Index Family/Social CompositeBaseline.29 units on a scaleStandard Deviation 0.22
12-Step Facilitation (TSF)Addiction Severity Index Family/Social CompositeEnd of Treatment.22 units on a scaleStandard Deviation 0.29
12-Step Facilitation (TSF)Addiction Severity Index Family/Social Composite3-month followup.30 units on a scaleStandard Deviation 0.24
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).

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

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)Addiction Severity Index Medical Composite ScoreBaseline.38 units on a scaleStandard Deviation 0.31
A Woman's Path to Recovery (WPR)Addiction Severity Index Medical Composite ScoreEnd of Treatment.38 units on a scaleStandard Deviation 0.29
A Woman's Path to Recovery (WPR)Addiction Severity Index Medical Composite Score3-month followup.21 units on a scaleStandard Deviation 0.28
12-Step Facilitation (TSF)Addiction Severity Index Medical Composite ScoreBaseline.43 units on a scaleStandard Deviation 0.38
12-Step Facilitation (TSF)Addiction Severity Index Medical Composite ScoreEnd of Treatment.33 units on a scaleStandard Deviation 0.3
12-Step Facilitation (TSF)Addiction Severity Index Medical Composite Score3-month followup.20 units on a scaleStandard Deviation 0.28
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).

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

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)Addiction Severity Index Psychiatric CompositeBaseline.43 units on a scaleStandard Deviation 0.21
A Woman's Path to Recovery (WPR)Addiction Severity Index Psychiatric CompositeEnd of Treatment.37 units on a scaleStandard Deviation 0.21
A Woman's Path to Recovery (WPR)Addiction Severity Index Psychiatric Composite3-month followup.31 units on a scaleStandard Deviation 0.21
12-Step Facilitation (TSF)Addiction Severity Index Psychiatric CompositeBaseline.48 units on a scaleStandard Deviation 0.18
12-Step Facilitation (TSF)Addiction Severity Index Psychiatric CompositeEnd of Treatment.41 units on a scaleStandard Deviation 0.18
12-Step Facilitation (TSF)Addiction Severity Index Psychiatric Composite3-month followup.39 units on a scaleStandard Deviation 0.19
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)Alcoholics Anonymous (AA) Intention MeasureBaseline5.21 units on a scaleStandard Deviation 1.27
A Woman's Path to Recovery (WPR)Alcoholics Anonymous (AA) Intention MeasureEnd of Treatment4.90 units on a scaleStandard Deviation 1.42
A Woman's Path to Recovery (WPR)Alcoholics Anonymous (AA) Intention Measure3-month followup4.99 units on a scaleStandard Deviation 0.98
12-Step Facilitation (TSF)Alcoholics Anonymous (AA) Intention MeasureBaseline5.26 units on a scaleStandard Deviation 1.1
12-Step Facilitation (TSF)Alcoholics Anonymous (AA) Intention MeasureEnd of Treatment4.97 units on a scaleStandard Deviation 1.34
12-Step Facilitation (TSF)Alcoholics Anonymous (AA) Intention Measure3-month followup4.97 units on a scaleStandard Deviation 1.07
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)BASIS-24 Psychosocial FunctioningBaseline36.22 units on a scaleStandard Deviation 12.32
A Woman's Path to Recovery (WPR)BASIS-24 Psychosocial FunctioningEnd of Treatment33.40 units on a scaleStandard Deviation 9.15
A Woman's Path to Recovery (WPR)BASIS-24 Psychosocial Functioning3-month followup29.80 units on a scaleStandard Deviation 7.68
12-Step Facilitation (TSF)BASIS-24 Psychosocial FunctioningBaseline38.05 units on a scaleStandard Deviation 10.63
12-Step Facilitation (TSF)BASIS-24 Psychosocial FunctioningEnd of Treatment34.12 units on a scaleStandard Deviation 6.9
12-Step Facilitation (TSF)BASIS-24 Psychosocial Functioning3-month followup29.57 units on a scaleStandard Deviation 6.31
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).

Time frame: Baseline, end of treatment, 3-month post-treatment follow-up

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)Coping Skills MeasureBaseline2.25 units on a scaleStandard Deviation 1.09
A Woman's Path to Recovery (WPR)Coping Skills MeasureEnd of Treatment2.88 units on a scaleStandard Deviation 0.99
A Woman's Path to Recovery (WPR)Coping Skills Measure3-month followup2.85 units on a scaleStandard Deviation 0.69
12-Step Facilitation (TSF)Coping Skills MeasureBaseline2.92 units on a scaleStandard Deviation 0.4
12-Step Facilitation (TSF)Coping Skills MeasureEnd of Treatment2.95 units on a scaleStandard Deviation 1.01
12-Step Facilitation (TSF)Coping Skills Measure3-month followup2.92 units on a scaleStandard Deviation 0.4
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
A Woman's Path to Recovery (WPR)Global Severity Index of the Brief Symptom InventoryBaseline1.55 units on a scaleStandard Deviation 1.21
A Woman's Path to Recovery (WPR)Global Severity Index of the Brief Symptom InventoryEnd of Treatment1.37 units on a scaleStandard Deviation 1.14
A Woman's Path to Recovery (WPR)Global Severity Index of the Brief Symptom Inventory3-month followup1.62 units on a scaleStandard Deviation 1.01
12-Step Facilitation (TSF)Global Severity Index of the Brief Symptom InventoryBaseline1.85 units on a scaleStandard Deviation 1.12
12-Step Facilitation (TSF)Global Severity Index of the Brief Symptom InventoryEnd of Treatment1.34 units on a scaleStandard Deviation 0.92
12-Step Facilitation (TSF)Global Severity Index of the Brief Symptom Inventory3-month followup1.26 units on a scaleStandard Deviation 0.88

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026