Preventing Violence Among Veterans in Substance Use Disorder Treatment

This study is currently recruiting participants.
Verified January 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01337973
First received: December 17, 2010
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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 Intervention
Aggression
Substance-Related Disorders
Behavioral: MI-CBT
Behavioral: MI-CBT+CC
Behavioral: E-TAU

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Interventions to Reduce Violence and Substance Abuse Among VA Patients

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Conflict Tactics Scale-Structured Interview (CTS-SI) [ Time Frame: baseline, post phase 2, three-, six- and twelve-month follow-ups ] [ Designated as safety issue: No ]
    Semi-structured interview assessing interpersonal violence (violence severity, injury and characteristics of interpersonal conflict incidents).


Secondary Outcome Measures:
  • Time Line Follow Back [ Time Frame: baseline, post phase 2, three-, six- and twelve-month follow-ups ] [ Designated as safety issue: No ]
    Semi-structured interview assessing alcohol and drug use.


Estimated Enrollment: 210
Study Start Date: June 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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 (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 (enhanced treatment as usual - includes brief session and provision of resources)
Behavioral: E-TAU
Enhanced Treatment as Usual

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with severe and recent violence (i.e., injuring another person in the past year as well as 1 or more incidents of physical aggression during the six months prior to treatment) 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337973

Contacts
Contact: Stephen T Chermack, PhD MA BA stephen.chermack2@va.gov
Contact: Shirley A Terlecki, BA MA (845) 845-3637 shirley.terlecki@va.gov

Locations
United States, Michigan
VA Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48113-0170
Contact: Stephen T Chermack, PhD MA BA       stephen.chermack2@va.gov   
Contact: Janet G Adams-Watson, MHSA BA    (734) 845-3604    jan.adams-watson@va.gov   
Sub-Investigator: Frederic C. Blow, PhD MA         
Sub-Investigator: Mark A. Ilgen, PhD         
Principal Investigator: Stephen T. Chermack, PhD MA BA         
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen T. Chermack, PhD MA BA Ann Arbor VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01337973     History of Changes
Other Study ID Numbers: IIR 09-333, HX000294
Study First Received: December 17, 2010
Last Updated: January 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
violence
aggression
Substance-Related Disorders
Alcohol-Related Disorders
Drug-Related Disorders

Additional relevant MeSH terms:
Aggression
Substance-Related Disorders
Behavioral Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014