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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.
 
ClinicalTrials.gov Identifier: NCT01337973
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE December 17, 2010
First Posted Date  ICMJE April 19, 2011
Results First Submitted Date  ICMJE December 21, 2017
Results First Posted Date  ICMJE September 6, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE June 20, 2012
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Violence Among Veterans in Substance Use Disorder Treatment
Official Title  ICMJE Impact of Interventions to Reduce Violence and Substance Abuse Among VA Patients
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Aggression
  • Substance-Related Disorders
Intervention  ICMJE
  • Behavioral: MI-CBT
    Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches
  • Behavioral: MI-CBT+CC
    Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention
  • Behavioral: E-TAU
    Enhanced Treatment as Usual
Study Arms  ICMJE
  • Experimental: Arm 1: MI-CBT
    MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)
    Intervention: Behavioral: MI-CBT
  • 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)
    Intervention: Behavioral: MI-CBT+CC
  • Active Comparator: Arm 3: E-TAU
    E-TAU (enhanced treatment as usual - includes brief session and provision of resources)
    Intervention: Behavioral: E-TAU
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2019)
180
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2011)
210
Actual Study Completion Date  ICMJE December 1, 2017
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01337973
Other Study ID Numbers  ICMJE IIR 09-333
HX000294 ( Other Grant/Funding Number: VA Merit Review Grant )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen T. Chermack, PhD MA BA VA Ann Arbor Healthcare System, Ann Arbor, MI
PRS Account VA Office of Research and Development
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP