Preventing Violence Among Veterans in Substance Use Disorder Treatment

NCT01337973 | Completed Results

• 2 other identifiers: IIR 09-333HX000294
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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. 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. 2.MI-CBT plus a continuing care (CC) intervention for the 3-month continuing care period following the early treatment phase MI-CBT+CC).

Conditions

Aggression; Substance-Related Disorders

Keywords

violence; aggression; Substance-Related Disorders; Alcohol-Related Disorders; Drug-Related Disorders

Outcome Measures

Primary Outcomes (1)

• Conflict Tactics Scale-Structured Interview (CTS-SI)

  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 Outcomes (1)

• Percent Change in the Percentage of Days of Substance Use for Each Substance

  % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data

Study Arms (3)

Arm 1: MI-CBT

EXPERIMENTAL

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

Behavioral: MI-CBT

Arm 2: MI-CBT+CC

EXPERIMENTAL

MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)

Behavioral: MI-CBT+CC

Arm 3: E-TAU

ACTIVE COMPARATOR

E-TAU (enhanced treatment as usual - includes brief session and provision of resources)

Behavioral: E-TAU

Interventions

MI-CBT BEHAVIORAL

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

Arm 1: MI-CBT

MI-CBT+CC BEHAVIORAL

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

Arm 2: MI-CBT+CC

E-TAU BEHAVIORAL

Enhanced Treatment as Usual

Arm 3: E-TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (6)

• Davis AK, Bonar EE, Ilgen MA, Walton MA, Perron BE, Chermack ST. Factors associated with having a medical marijuana card among Veterans with recent substance use in VA outpatient treatment. Addict Behav. 2016 Dec;63:132-6. doi: 10.1016/j.addbeh.2016.07.006. Epub 2016 Jul 8.

  PMID: 27475408 BACKGROUND

• Bennett DC, Morris DH, Sexton MB, Bonar EE, Chermack ST. Associations between posttraumatic stress and legal charges among substance using veterans. Law Hum Behav. 2018 Apr;42(2):135-144. doi: 10.1037/lhb0000268. Epub 2017 Oct 26.

  PMID: 29072473 BACKGROUND

• Anderson RE, Bonar EE, Walton MA, Goldstick JE, Rauch SAM, Epstein-Ngo QM, Chermack ST. A Latent Profile Analysis of Aggression and Victimization Across Relationship Types Among Veterans Who Use Substances. J Stud Alcohol Drugs. 2017 Jul;78(4):597-607. doi: 10.15288/jsad.2017.78.597.

  PMID: 28728642 BACKGROUND

• Davis AK, Bonar EE, Goldstick JE, Walton MA, Winters J, Chermack ST. Binge-drinking and non-partner aggression are associated with gambling among Veterans with recent substance use in VA outpatient treatment. Addict Behav. 2017 Nov;74:27-32. doi: 10.1016/j.addbeh.2017.05.022. Epub 2017 May 20.

  PMID: 28570911 BACKGROUND

• Buchholz KR, Bohnert KM, Sripada RK, Rauch SA, Epstein-Ngo QM, Chermack ST. Associations between PTSD and intimate partner and non-partner aggression among substance using veterans in specialty mental health. Addict Behav. 2017 Jan;64:194-199. doi: 10.1016/j.addbeh.2016.08.039. Epub 2016 Aug 31.

  PMID: 27636157 BACKGROUND

• Chermack ST, Bonar EE, Goldstick JE, Winters J, Blow FC, Friday S, Ilgen MA, Rauch SAM, Perron BE, Ngo QM, Walton MA. A randomized controlled trial for aggression and substance use involvement among Veterans: Impact of combining Motivational Interviewing, Cognitive Behavioral Treatment and telephone-based Continuing Care. J Subst Abuse Treat. 2019 Mar;98:78-88. doi: 10.1016/j.jsat.2019.01.001. Epub 2019 Jan 4.

  PMID: 30665608 RESULT

MeSH Terms

Conditions

Aggression; Substance-Related Disorders; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

We fell short of recruitment goal of 210 participants and had a low number of women per group. Rates of aggression at each follow-up were very low so we collapsed across the 3,6 \& 12 month follow-ups when examining changes from baseline to follow-up.

Results Point of Contact

• Title: Stephen Chermack, Ph.D.
• Organization: VA Ann Arbor

chermack@umich.edu

734 845-5046

Study Officials

• Stephen T. Chermack, PhD MA BA

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: April 19, 2011
• Study Start: June 20, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)