Trial Outcomes & Findings for Preventing Violence Among Veterans in Substance Use Disorder Treatment (NCT NCT01337973)

Last Updated: 2019-09-06

Results Overview

The CTS-SI is a semi-structured interview assessing interpersonal violence (violence severity, injury and characteristics of interpersonal conflict incidents). Baseline data collection assessed the 180 days prior to enrollment, and follow-up data was collected at 3 and 6 months for the prior 90 days, and at 12 months for the past 180 days. The analysis below compares the month rate of various types of interpersonal aggression from the period pre-baseline to the monthly rate post-intervention (across all 12 months of follow-up) in the form of % difference. Means at baseline, 3 , 6 and 12 months were compared resulting in a number with no measure of dispersion. Values were calculated across all participants. There were primary aggression outcomes (overall physical aggression, injuring another person), and secondary aggression outcomes (partner physical aggression and injury, nonpartner physical aggression and injury).

Recruitment status

COMPLETED

Study phase

Target enrollment

180 participants

Primary outcome timeframe

% difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data

Results posted on

2019-09-06

Participant Flow

Participants were recruited from June 2012-June 2015 from outpatient VA mental health programs (Substance Use Disorder, Substance use Disorder Intensive Outpatient, General Mental Health).

Of 1097 eligible for screening, 183 refused participation (17%), 75 (7%) were missed and 839 completed the screening assessment. Of those completing screening, 639 were not eligible for the RCT and 20 refused further participation. Thus, 180 out of 200 eligible veterans (90%) were randomized to one of the three treatment conditions.

Participant milestones

Participant milestones
Measure	Arm 1: MI-CBT MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches) MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches	Arm 2: MI-CBT+CC MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention) MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention	Arm 3: E-TAU E-TAU (enhanced treatment as usual - includes brief session and provision of resources) E-TAU: Enhanced Treatment as Usual
Overall Study STARTED	60	60	60
Overall Study COMPLETED	44	45	49
Overall Study NOT COMPLETED	16	15	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: MI-CBT MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches) MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches	Arm 2: MI-CBT+CC MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention) MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention	Arm 3: E-TAU E-TAU (enhanced treatment as usual - includes brief session and provision of resources) E-TAU: Enhanced Treatment as Usual
Overall Study Lost to Follow-up	2	4	3
Overall Study Death	1	2	1
Overall Study Withdrawal by Subject	10	8	4
Overall Study missing data on primary outcome	3	1	3

Baseline Characteristics

Preventing Violence Among Veterans in Substance Use Disorder Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: MI-CBT n=60 Participants MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches) MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches	Arm 2: MI-CBT+CC n=60 Participants MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention) MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention	Arm 3: E-TAU n=60 Participants E-TAU (enhanced treatment as usual - includes brief session and provision of resources) E-TAU: Enhanced Treatment as Usual	Total n=180 Participants Total of all reporting groups
Age, Continuous	39.9 years STANDARD_DEVIATION 12.9 • n=93 Participants	44.9 years STANDARD_DEVIATION 12.9 • n=4 Participants	42.9 years STANDARD_DEVIATION 12.8 • n=27 Participants	42.6 years STANDARD_DEVIATION 13.0 • n=483 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants	15 Participants n=483 Participants
Sex: Female, Male Male	55 Participants n=93 Participants	55 Participants n=4 Participants	55 Participants n=27 Participants	165 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	6 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=93 Participants	55 Participants n=4 Participants	57 Participants n=27 Participants	167 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	7 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	14 Participants n=93 Participants	18 Participants n=4 Participants	19 Participants n=27 Participants	51 Participants n=483 Participants
Race (NIH/OMB) White	41 Participants n=93 Participants	35 Participants n=4 Participants	38 Participants n=27 Participants	114 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	6 Participants n=4 Participants	3 Participants n=27 Participants	14 Participants n=483 Participants
Region of Enrollment United States	60 Participants n=93 Participants	60 Participants n=4 Participants	60 Participants n=27 Participants	180 Participants n=483 Participants

PRIMARY outcome

Timeframe: % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data

Population: Main analyses used General Estimating Equations which accounts for missing data. Results in tables below are from bivariate analyses.

Outcome measures

Outcome measures
Measure	Arm 1: MI-CBT n=60 Participants MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches) MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches	Arm 2: MI-CBT+CC n=60 Participants MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention) MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention	Arm 3: E-TAU n=60 Participants E-TAU (enhanced treatment as usual - includes brief session and provision of resources) E-TAU: Enhanced Treatment as Usual
Conflict Tactics Scale-Structured Interview (CTS-SI) Overall physical aggression % change from baseline	-90 percentage change	-90 percentage change	-94 percentage change
Conflict Tactics Scale-Structured Interview (CTS-SI) Overall Injury Perpetration % change from baseline	-82 percentage change	-91 percentage change	-86 percentage change
Conflict Tactics Scale-Structured Interview (CTS-SI) Partner physical aggression % change from baseline	-92 percentage change	-91 percentage change	-97 percentage change
Conflict Tactics Scale-Structured Interview (CTS-SI) Partner injury % change from baseline	-100 percentage change	-85 percentage change	-61 percentage change
Conflict Tactics Scale-Structured Interview (CTS-SI) Nonpartner physical aggresion % change from baseli	-88 percentage change	-89 percentage change	-90 percentage change
Conflict Tactics Scale-Structured Interview (CTS-SI) Nonpartner injury % change from baseline	-76 percentage change	-93 percentage change	-99 percentage change

SECONDARY outcome

Timeframe: % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data

Population: Main analyses used General Estimating Equations which accounts for missing data. Results in data table are from bivariate analyses.

Data was collected via a Time-line Follow Back interview. Semi-structured interview assessing alcohol and drug use. Baseline data collection assessed the 180 days prior to enrollment, and follow-up data was collected at 3 and 6 months for the prior 90 days, and at 12 months for the past 180 days. The analysis below compares the monthly rate of various types of substance use (heavy drinking, cocaine, marijuana, and illicit) from the period pre-baseline to the monthly rate post-intervention (across all 12 months of follow-up) in the form of % difference. (% days use for each substance) Means at baseline, 3 , 6 and 12 months were compared resulting in a number with no measure of dispersion. Values were calculated across all participants.

Outcome measures

Outcome measures
Measure	Arm 1: MI-CBT n=60 Participants MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches) MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches	Arm 2: MI-CBT+CC n=60 Participants MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention) MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention	Arm 3: E-TAU n=60 Participants E-TAU (enhanced treatment as usual - includes brief session and provision of resources) E-TAU: Enhanced Treatment as Usual
Percent Change in the Percentage of Days of Substance Use for Each Substance Heavy Drinking % change from baseline	-68 percentage of change	-59 percentage of change	-55 percentage of change
Percent Change in the Percentage of Days of Substance Use for Each Substance cocaine use % change from baseline	-83 percentage of change	-86 percentage of change	-56 percentage of change
Percent Change in the Percentage of Days of Substance Use for Each Substance marijuana use % change from baseline	-40 percentage of change	-42 percentage of change	-44 percentage of change
Percent Change in the Percentage of Days of Substance Use for Each Substance Overall illicit drug use % change from baseline	-52 percentage of change	-50 percentage of change	-57 percentage of change

Adverse Events

Arm 1: MI-CBT

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Arm 2: MI-CBT+CC

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Arm 3: E-TAU

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: MI-CBT n=60 participants at risk MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches) MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches	Arm 2: MI-CBT+CC n=60 participants at risk MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention) MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention	Arm 3: E-TAU n=60 participants at risk E-TAU (enhanced treatment as usual - includes brief session and provision of resources) E-TAU: Enhanced Treatment as Usual
Social circumstances Participant Death	1.7% 1/60 • Number of events 1 In the event of participant death, cause of death is unknown.	3.3% 2/60 • Number of events 2 In the event of participant death, cause of death is unknown.	1.7% 1/60 • Number of events 1 In the event of participant death, cause of death is unknown.

Other adverse events

Adverse event data not reported

Additional Information

Stephen Chermack, Ph.D.

VA Ann Arbor

Phone: 734 845-5046

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place