N/A
N=180
Preventing Violence Among Veterans in Substance Use Disorder Treatment
Aggression · Substance-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01337973 ↗Enrolled (actual)
180
Serious AEs
2.2%
Results posted
Sep 2019
Primary outcome: Primary: Conflict Tactics Scale-Structured Interview (CTS-SI) — -90; -90; -94; -82 percentage change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MI-CBT (Behavioral); MI-CBT+CC (Behavioral); E-TAU (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conflict Tactics Scale-Structured Interview (CTS-SI) |
-90; -90; -94; -82; -91; -86 | <0.001 sig |
| SECONDARY Percent Change in the Percentage of Days of Substance Use for Each Substance |
-68; -59; -55; -83; -86; -56 | <0.001 sig |
Summary
The purpose of this study is to examine the impact on both clinical (violence and substance use) outcomes and health services use (substance use disorder and mental health treatment) compared to standard SUD treatment (enhanced treatment as usual) of
1. an integrated Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT) violence prevention treatment intervention delivered during the 8-week early substance use disorder treatment phase; and
2. MI-CBT plus a continuing care (CC) intervention for the 3-month continuing care period following the early treatment phase MI-CBT+CC).
The study will provide important new information regarding the role and relative impact of both early treatment and continuing care interventions designed to impact substance use and violence, and whether combining such interventions yields additional benefits.
Eligibility Criteria
Inclusion Criteria
- Participants with severe and recent violence (i.e., injuring another person in the past year) will be eligible for the RCT.
- Eligible patients also will meet DSM-IV criteria for either alcohol or illicit drug (e.g., cocaine, marijuana, opiates, etc.) abuse/dependence.
- The study will include those with comorbid mood and/or anxiety problems (e.g., depression, PTSD and other anxiety disorders), whether or not on medication at the point of recruitment, with the exception of those who have schizophrenia and/or are mentally incompetent (e.g., unable to provide informed consent).
- A brief mental status screen will with an established cutoff will be required for competency.
Exclusion Criteria
- Participants who are suicidal (ideation, intent and plan) at the point of recruitment will not be enrolled in the study. Rather, research staff will inform clinical staff at the study site if a potential participant is currently suicidal.
- Participants who report transient suicidal ideation but no intent or plan will be eligible to participate.
- As noted, individuals with schizophrenia and/or who are mentally incompetent to consent for participation will be excluded. Finally, participants who live outside the study catchment area (i.e., a 45 mile radius of the VA Ann Arbor Healthcare System) will be excluded.
Data sourced from ClinicalTrials.gov (NCT01337973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.