Preventing Violence Among Veterans in Substance Use Disorder Treatment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-20

Study Completion Date

2017-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Developing Violence Prevention Therapy for Substance Abusers

NCT00551863

Substance Use Disorders Violence

COMPLETED PHASE1/PHASE2

Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

NCT02439762

Suicide Suicidal Ideation Substance-Related Disorders

COMPLETED NA

Treating Violence-Prone Substance Use Disorder Patients

NCT00700973

Substance-related Disorders Violence

COMPLETED PHASE2/PHASE3

Personalized Approach to Healthy Use and Recovery (PATH) Trial

NCT06580457

Substance Use Disorder

RECRUITING NA

Adjunctive Motivational Alcohol Intervention to Prevent IPV

NCT05287711

Alcohol Use and Intimate Partner Violence

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective: Rates of violence in Substance Use Disorder (SUD) treatment samples often exceed 50%, with studies showing rates of past-year violence \>70% when considering violence occurring with either intimate partners or others. Violence has numerous costs to Veterans and their families, in terms of physical (e.g., injuries) and psychosocial problems (mental health, legal problems, marital problems, poorer functioning for their children, etc.). To date, only one treatment approach (Behavioral Couples Therapy - BCT) has been established that reduces both substance use and violence, and BCT focuses exclusively on the couples' relationship. Given that a small proportion of Veterans in SUD treatment have a partner willing or able to attend treatment, and that a substantial amount of violence occurs with non-partners, there is a clear need for interventions that do not require partner participation and focus on violence and relapse prevention more generally. Based on prior findings, new intervention approaches targeting the use of violence prevention skills and means of sustaining substance use remission are needed.

The primary objectives of this study are to examine the impact on both substance use and violence outcomes of:

1. an acute treatment phase integrated Motivational Interviewing-Cognitive Behavioral Treatment intervention (MI-CBT); and
2. MI-CBT plus a violence and substance use prevention Continuing Care intervention (MI-CBT+CC) intervention.

Research Plan: Participants will be randomized to one of three conditions: MI-CBT, MI-CBT+CC or an enhanced treatment as usual (E-TAU) control condition with follow-up interviews targeting violence and substance use outcomes at 3, 6 and 12-months. The MI-CBT intervention involves six individual sessions delivered during the acute SUD treatment phase, combines Motivational Interviewing (MI) and CBT approaches targeting violence and substance use, and has been developed, piloted and refined by the investigators. The MI-CBT+CC intervention includes acute phase MI-CBT plus weekly telephone sessions for an additional 3-month period, and is designed to address both post-treatment violence and substance use through facilitating SUD remission and use of violence prevention skills. The MI-CBT+CC intervention is adapted from a continuing care intervention shown to help consolidate and maintain gains made in treatment.

Methods: Veterans with substance use disorders will be recruited from the Substance Abuse Clinic (SAC) at the VA Ann Arbor Healthcare system. Approximately 855 Veterans enrolling in SAC will be consented and screened, and those screening positive for severe and recent violence (\~30%) and meeting other project inclusion/exclusion criteria will be eligible for participation in the randomized controlled trial (n = 210). The clinical interventions will be delivered by master's level clinicians, who will be monitored and supervised by licensed psychologists. Primary dependent measures (violence, substance use) will be measured at baseline and follow-up interviews, and the impact of the interventions on services use during the follow-up period also will be examined.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aggression Substance-Related Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: MI-CBT

MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)

Group Type EXPERIMENTAL

MI-CBT

Intervention Type BEHAVIORAL

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)

Group Type EXPERIMENTAL

MI-CBT+CC

Intervention Type BEHAVIORAL

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)

Group Type ACTIVE_COMPARATOR

E-TAU

Intervention Type BEHAVIORAL

Enhanced Treatment as Usual

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MI-CBT

Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches

Intervention Type BEHAVIORAL

MI-CBT+CC

Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention

Intervention Type BEHAVIORAL

E-TAU

Enhanced Treatment as Usual

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No