Preventing Violence Among Veterans in Substance Use Disorder Treatment

July 26, 2019 updated by: VA Office of Research and Development

Impact of Interventions to Reduce Violence and Substance Abuse Among VA Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: MI-CBT
MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)
Behavioral: MI-CBT
Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches
Experimental: Arm 2: MI-CBT+CC
MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)
Behavioral: MI-CBT+CC
Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention
Active Comparator: Arm 3: E-TAU
E-TAU (enhanced treatment as usual - includes brief session and provision of resources)
Behavioral: E-TAU
Enhanced Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conflict Tactics Scale-Structured Interview (CTS-SI)
Time Frame: % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data
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).
% difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in the Percentage of Days of Substance Use for Each Substance
Time Frame: % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data
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.
% difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Stephen T. Chermack, PhD MA BA, VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 17, 2010

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 09-333
  • HX000294 (Other Grant/Funding Number: VA Merit Review Grant)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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