Preventing Violence Among Veterans in Substance Use Disorder Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01337973
Recruitment Status : Active, not recruiting
First Posted : April 19, 2011
Last Update Posted : May 8, 2017
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Aggression Substance-Related Disorders Behavioral: MI-CBT Behavioral: MI-CBT+CC Behavioral: E-TAU Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Interventions to Reduce Violence and Substance Abuse Among VA Patients
Actual Study Start Date : June 20, 2012
Actual Primary Completion Date : December 1, 2016
Estimated Study Completion Date : December 2017

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

Primary Outcome Measures :
  1. Conflict Tactics Scale-Structured Interview (CTS-SI) [ Time Frame: baseline, post phase 2, three-, six- and twelve-month follow-ups ]
    Semi-structured interview assessing interpersonal violence (violence severity, injury and characteristics of interpersonal conflict incidents).

Secondary Outcome Measures :
  1. Time Line Follow Back [ Time Frame: baseline, post phase 2, three-, six- and twelve-month follow-ups ]
    Semi-structured interview assessing alcohol and drug use.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01337973

United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Stephen T. Chermack, PhD MA BA VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT01337973     History of Changes
Other Study ID Numbers: IIR 09-333
HX000294 ( Other Grant/Funding Number: VA Merit Review Grant )
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by VA Office of Research and Development:
Substance-Related Disorders
Alcohol-Related Disorders
Drug-Related Disorders

Additional relevant MeSH terms:
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Behavioral Symptoms