Trial Outcomes & Findings for Women Veterans' Substance Abuse Treatment (NCT NCT00734903)

NCT ID: NCT00734903

Last Updated: 2018-11-05

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
• Results posted on: 2018-11-05

Participant Flow

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

Participant milestones

Measure	A Woman's Path to Recovery (WPR) A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) An evidence-based, non-gender-focused approach to addiction recovery
Overall Study STARTED	33	33
Overall Study Completed End of Treatment Assessment	21	23
Overall Study Completed 3-month Followup	14	15
Overall Study COMPLETED	30	32
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Women Veterans' Substance Abuse Treatment

Baseline characteristics by cohort

Measure	A Woman's Path to Recovery (WPR) n=33 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=33 Participants An evidence-based, non-gender-focused approach to addiction recovery	Total n=66 Participants Total of all reporting groups
Age, Continuous	46.97 years STANDARD_DEVIATION 9.92 • n=5 Participants	48.45 years STANDARD_DEVIATION 8.13 • n=7 Participants	47.72 years STANDARD_DEVIATION 9.01 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants

PRIMARY outcome

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

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).

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=26 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=28 Participants An evidence-based, non-gender-focused approach to addiction recovery
Addiction Severity Index Alcohol Composite Baseline	.36 units on a scale Standard Deviation .24	.46 units on a scale Standard Deviation .35
Addiction Severity Index Alcohol Composite End of Treatment	.18 units on a scale Standard Deviation .21	.26 units on a scale Standard Deviation .24
Addiction Severity Index Alcohol Composite 3-month followup	.23 units on a scale Standard Deviation .19	.21 units on a scale Standard Deviation .11

PRIMARY outcome

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

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).

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=26 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=28 Participants An evidence-based, non-gender-focused approach to addiction recovery
Addiction Severity Index Drug Composite Baseline	.10 units on a scale Standard Deviation .11	.10 units on a scale Standard Deviation .12
Addiction Severity Index Drug Composite End of Treatment	.04 units on a scale Standard Deviation .05	.06 units on a scale Standard Deviation .06
Addiction Severity Index Drug Composite 3-month followup	.04 units on a scale Standard Deviation .05	.04 units on a scale Standard Deviation .05

PRIMARY outcome

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

Assesses number of days in the past 30 days that person used substances including alcohol and drugs

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=31 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=31 Participants An evidence-based, non-gender-focused approach to addiction recovery
Brief Addiction Monitor Baseline	4.61 days out of past 30 days Standard Deviation 3.50	4.48 days out of past 30 days Standard Deviation 3.85
Brief Addiction Monitor End of Treatment	1.96 days out of past 30 days Standard Deviation 2.08	2.33 days out of past 30 days Standard Deviation 3.17
Brief Addiction Monitor 3-month followup	2.33 days out of past 30 days Standard Deviation 1.92	1.92 days out of past 30 days Standard Deviation 2.36

SECONDARY outcome

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

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).

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=27 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=28 Participants An evidence-based, non-gender-focused approach to addiction recovery
Addiction Severity Index Medical Composite Score Baseline	.38 units on a scale Standard Deviation .31	.43 units on a scale Standard Deviation .38
Addiction Severity Index Medical Composite Score End of Treatment	.38 units on a scale Standard Deviation .29	.33 units on a scale Standard Deviation .30
Addiction Severity Index Medical Composite Score 3-month followup	.21 units on a scale Standard Deviation .28	.20 units on a scale Standard Deviation .28

SECONDARY outcome

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

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).

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=27 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=28 Participants An evidence-based, non-gender-focused approach to addiction recovery
Addiction Severity Index Employment Composite Baseline	.64 units on a scale Standard Deviation .27	.59 units on a scale Standard Deviation .34
Addiction Severity Index Employment Composite End of Treatment	.58 units on a scale Standard Deviation .29	.54 units on a scale Standard Deviation .33
Addiction Severity Index Employment Composite 3-month followup	.58 units on a scale Standard Deviation .28	.56 units on a scale Standard Deviation .32

SECONDARY outcome

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

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).

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=27 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=28 Participants An evidence-based, non-gender-focused approach to addiction recovery
Addiction Severity Index Psychiatric Composite Baseline	.43 units on a scale Standard Deviation .21	.48 units on a scale Standard Deviation .18
Addiction Severity Index Psychiatric Composite End of Treatment	.37 units on a scale Standard Deviation .21	.41 units on a scale Standard Deviation .18
Addiction Severity Index Psychiatric Composite 3-month followup	.31 units on a scale Standard Deviation .21	.39 units on a scale Standard Deviation .19

SECONDARY outcome

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

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).

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=26 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=28 Participants An evidence-based, non-gender-focused approach to addiction recovery
Addiction Severity Index Family/Social Composite Baseline	.20 units on a scale Standard Deviation .21	.29 units on a scale Standard Deviation .22
Addiction Severity Index Family/Social Composite End of Treatment	.14 units on a scale Standard Deviation .15	.22 units on a scale Standard Deviation .29
Addiction Severity Index Family/Social Composite 3-month followup	.23 units on a scale Standard Deviation .23	.30 units on a scale Standard Deviation .24

SECONDARY outcome

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

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.

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=31 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=31 Participants An evidence-based, non-gender-focused approach to addiction recovery
Global Severity Index of the Brief Symptom Inventory Baseline	1.55 units on a scale Standard Deviation 1.21	1.85 units on a scale Standard Deviation 1.12
Global Severity Index of the Brief Symptom Inventory End of Treatment	1.37 units on a scale Standard Deviation 1.14	1.34 units on a scale Standard Deviation .92
Global Severity Index of the Brief Symptom Inventory 3-month followup	1.62 units on a scale Standard Deviation 1.01	1.26 units on a scale Standard Deviation .88

SECONDARY outcome

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

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.

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=31 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=31 Participants An evidence-based, non-gender-focused approach to addiction recovery
BASIS-24 Psychosocial Functioning Baseline	36.22 units on a scale Standard Deviation 12.32	38.05 units on a scale Standard Deviation 10.63
BASIS-24 Psychosocial Functioning End of Treatment	33.40 units on a scale Standard Deviation 9.15	34.12 units on a scale Standard Deviation 6.90
BASIS-24 Psychosocial Functioning 3-month followup	29.80 units on a scale Standard Deviation 7.68	29.57 units on a scale Standard Deviation 6.31

SECONDARY outcome

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

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).

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=31 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=31 Participants An evidence-based, non-gender-focused approach to addiction recovery
Coping Skills Measure Baseline	2.25 units on a scale Standard Deviation 1.09	2.92 units on a scale Standard Deviation .40
Coping Skills Measure End of Treatment	2.88 units on a scale Standard Deviation .99	2.95 units on a scale Standard Deviation 1.01
Coping Skills Measure 3-month followup	2.85 units on a scale Standard Deviation .69	2.92 units on a scale Standard Deviation .40

SECONDARY outcome

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

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.

Outcome measures

Measure	A Woman's Path to Recovery (WPR) n=29 Participants A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=28 Participants An evidence-based, non-gender-focused approach to addiction recovery
Alcoholics Anonymous (AA) Intention Measure Baseline	5.21 units on a scale Standard Deviation 1.27	5.26 units on a scale Standard Deviation 1.10
Alcoholics Anonymous (AA) Intention Measure End of Treatment	4.90 units on a scale Standard Deviation 1.42	4.97 units on a scale Standard Deviation 1.34
Alcoholics Anonymous (AA) Intention Measure 3-month followup	4.99 units on a scale Standard Deviation .98	4.97 units on a scale Standard Deviation 1.07

Adverse Events

A Woman's Path to Recovery (WPR)

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

12-Step Facilitation (TSF)

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	A Woman's Path to Recovery (WPR) n=33 participants at risk A gender-focused approach to addiction recovery	12-Step Facilitation (TSF) n=33 participants at risk An evidence-based, non-gender-focused approach to addiction recovery
Investigations adverse events	12.1% 4/33 • 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.	21.2% 7/33 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Lisa Najavits, PhD

VA BOSTON

Phone: 617-299-1620

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

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place