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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02524171
Other study ID # IIR 14-081
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 4, 2016
Est. completion date March 30, 2021

Study information

Verified date July 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Moral Reconation Therapy (MRT) is effective for reducing risk of criminal recidivism and improving other health-related outcomes (substance use, mental health, housing, and employment problems) among justice-involved Veterans entering residential mental health treatment programs in the Department of Veterans Affairs (VA).


Description:

Approximately 146,000 Veterans are released each year from correctional settings; however, two thirds will likely reoffend and return to the justice system. Antisocial cognitions and behaviors are the strongest predictors of reoffending and are highly prevalent among justice-involved Veterans (JIVs). However, in the absence of treatments with demonstrated effectiveness with JIVs, no systematic approach to address antisocial cognitions and behaviors has been implemented in VA. Moral Reconation Therapy (MRT) is a cognitive-behavioral intervention that aims to reduce antisocial cognitions and behaviors. MRT has the best empirical support for reducing risk for criminal recidivism among civilian offenders, and its associated mechanisms (improvements in interpersonal functioning and impulse control) have been linked to improvements in health-related outcomes that are also risk factors for recidivism (substance use, mental health, housing, and employment problems). However, no trials have been conducted with JIVs. Differences between JIVs and justice-involved civilians (e.g., prevalence of traumatic brain injuries; interpersonal problems) suggests prior research on MRT with civilians may not be generalizable, and prompted the VA's Veterans Justice Programs (VJP) and the developers of MRT to develop a Veteran-specific curriculum of this intervention. Using the new Veteran-specific manual, the overarching objective of the current proposal is to implement and evaluate MRT as an intervention to reduce risk for criminal recidivism and improve health-related outcomes among JIVs in VA Mental Health Residential Rehabilitation Treatment Programs (MH RRTPs). Using a Hybrid Type 1 design, this project will test the effectiveness of MRT in a multisite Randomized Controlled Trial (RCT) (Palo Alto, Little Rock, and Bedford VAs) and conduct a formative evaluation to facilitate future implementation of MRT in VA.


Recruitment information / eligibility

Status Completed
Enrollment 344
Est. completion date March 30, 2021
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Veterans who - (a) are entering a mental health residential rehabilitation treatment program (MH RRTP) at one of three study sites (Palo Alto, Little Rock, or Bedford VA), and - (b) had been arrested and charged and/or released from incarceration in the past 5 years prior to MH RRTP admission will be eligible for participation Exclusion Criteria: - The only exclusion criterion is being too cognitively impaired to understand the informed consent process and other study procedures.

Study Design


Intervention

Behavioral:
Moral Reconation Therapy (MRT)
MRT is a group-based cognitive-behavioral intervention to restructure antisocial thinking. Patients will receive two groups per week of this intervention for approximately 12 weeks, in addition to the usual care they receive in the mental health residential rehabilitation treatment program.

Locations

Country Name City State
United States VA Bedford HealthCare System, Bedford, MA Bedford Massachusetts
United States Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR North Little Rock Arkansas
United States VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

Blonigen DM, Cucciare MA, Byrne T, Shaffer PM, Giordano B, Smith JS, Timko C, Rosenthal J, Smelson D. A randomized controlled trial of moral reconation therapy to reduce risk for criminal recidivism among justice-involved adults in mental health residenti — View Citation

Blonigen DM, Cucciare MA, Timko C, Smith JS, Harnish A, Kemp L, Rosenthal J, Smelson D. Study protocol: a hybrid effectiveness-implementation trial of Moral Reconation Therapy in the US Veterans Health Administration. BMC Health Serv Res. 2018 Mar 7;18(1) — View Citation

Blonigen DM, Smith JS, Javier S, Cucciare MA, Timko C, Nevedal AL, Filice N, Rosenthal J, Smelson D. Implementation Potential of Moral Reconation Therapy for Criminal Recidivism in Mental Health Residential Programs. Psychiatr Serv. 2022 Aug 1;73(8):856-8 — View Citation

Timko C, Booth BM, Han X, Schultz NR, Blonigen DM, Wong JJ, Cucciare MA. Criminogenic Needs, Substance Use, and Offending among Rural Stimulant Users. Rural Ment Health. 2017 Apr;41(2):110-122. doi: 10.1037/rmh0000065. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Risk for Criminal Recidivism (Criminal Thinking) The Psychological Inventory of Criminal Thinking Styles (56 items) was administered to assess criminal thinking. The measure includes scales of Mollification, Cutoff, Entitlement, Power Orientation, Super-optimism, Cognitive Indolence, and Discontinuity . Scores on these scales were summed to create a General Criminal Thinking score, which has been validated as an overall index of recidivism risk. Higher scores equate to more criminal thinking. Scores were converted to a T-score metric (M=50, SD=10), calculated in reference to norms from samples of incarcerated offenders. 6 months (post-baseline)
Primary Risk for Criminal Recidivism (Criminal Thinking) The Psychological Inventory of Criminal Thinking Styles (56 items) was administered to assess criminal thinking. The measure includes scales of Mollification, Cutoff, Entitlement, Power Orientation, Super-optimism, Cognitive Indolence, and Discontinuity . Scores on these scales were summed to create a General Criminal Thinking score, which has been validated as an overall index of recidivism risk. Higher scores equate to more criminal thinking. Scores were converted to a T-score metric (M=50, SD=10), calculated in reference to norms from samples of incarcerated offenders. 12 months (post-baseline)
Secondary Alcohol Use The quantity and frequency of patients' self-reported alcohol use in the past 6 months, measured with the Timeline Follow-Back interview that was administered at the 6-month follow-up interview. 6 months (post-baseline)
Secondary Drug Use The quantity and frequency of patients' self-reported drug use in the past 6 months, measured with the Timeline Follow-Back interview. It was administered at each time point to calculate for the past 6 months total number of days using any drugs (marijuana, cocaine, amphetamines, heroin, other opiates, benzodiazepines, barbiturates, inhalants, or hallucinogens). 6 months (post-baseline)
Secondary Criminal Associates Scale A of the Measures of Criminal Attitudes and Associates (MCAA; Mills, Kroner, & Forth, 2002) was administered at each interview to quantify participants' associations with criminal peers, a strong predictor of criminal recidivism (Mills, Kroner, & Hemmati, 2004). Participants were asked to consider the four adults (excluding family, co-workers, or other residents in treatment) with whom they spend the most free-time. A count variable was created by summing the number of friends for which the participant answered yes to any of the questions of criminal involvement (possible range=0-4, where a higher score indicates a worse outcome) 6 months (post-baseline)
Secondary Employment Problem Severity The Employment module of the ASI was administered at each timepoint to assess problem severity in this domain, using composite score indices (range 0 to 1); higher scores indicate greater problem severity. 6 months (post-baseline)
Secondary Alcohol Use Problem Severity. The Alcohol module of the ASI was administered at each time point to assess problem severity in this domain, using composite score indices (ranging from 0 to 1); higher scores indicate greater problem severity. ASI composite scores such as this have long been used to provide internally-consistent evaluations of a patient in a particular problem area (Grahn & Padyab, 2020). 6 months (post-baseline)
Secondary Legal Problem Severity The Legal Status module of the Addiction Severity Index (ASI; McLellan et al., 2006) was administered at each interview to assess legal problem severity. The latter is based on a composite index derived from five items: Are you presently awaiting charges, trial, or sentence? How many days in the past 30 have you engaged in illegal activities for profit? How serious do you feel your present legal problems are? (0=Not at all, 4=Extremely) How important to you now is counseling or referral for these legal problems? (0=Not at all, 4=Extremely) How much money did you receive from illegal sources in the past 30 days? These items were standardized and aggregated and yield scores ranging from 0 to 1; higher scores indicate greater problem severity of legal problems. 6 months (post-baseline)
Secondary Family/Social Problems The Family/Social module of the ASI was administered at each timepoint to assess problem severity in this domain, using composite score indices (range 0 to 1); higher scores indicate greater problem severity. 6 months (post-baseline)
Secondary Alcohol Use The quantity and frequency of patients' self-reported alcohol use in the past 6 months, measured with the Timeline Follow-Back interview that was administered at the 12-month follow-up interview. 12 months (post-baseline)
Secondary Drug Use The quantity and frequency of patients' self-reported drug use in the past 6 months, measured with the Timeline Follow-Back interview. It was administered at each time point to calculate for the past 6 months total number of days using any drugs (marijuana, cocaine, amphetamines, heroin, other opiates, benzodiazepines, barbiturates, inhalants, or hallucinogens). 12 months (post-baseline)
Secondary Criminal Associates Scale A of the Measures of Criminal Attitudes and Associates (MCAA; Mills, Kroner, & Forth, 2002) was administered at each interview to quantify participants' associations with criminal peers, a strong predictor of criminal recidivism (Mills, Kroner, & Hemmati, 2004). Participants were asked to consider the four adults (excluding family, co-workers, or other residents in treatment) with whom they spend the most free-time. A count variable was created by summing the number of friends for which the participant answered yes to any of the questions of criminal involvement (possible range=0-4, where a higher score indicates a worse outcome) 12 months (post-baseline)
Secondary Employment Problem Severity The Employment module of the ASI was administered at each timepoint to assess problem severity in this domain, using composite score indices (range 0 to 1); higher scores indicate greater problem severity. 12 months (post-baseline)
Secondary Alcohol Use Problem Severity. The Alcohol module of the ASI was administered at each time point to assess problem severity in this domain, using composite score indices (ranging from 0 to 1); higher scores indicate greater problem severity. ASI composite scores such as this have long been used to provide internally-consistent evaluations of a patient in a particular problem area (Grahn & Padyab, 2020). 12 months (post-baseline)
Secondary Legal Problem Severity The Legal Status module of the Addiction Severity Index (ASI; McLellan et al., 2006) was administered at each interview to assess legal problem severity. The latter is based on a composite index derived from five items: Are you presently awaiting charges, trial, or sentence? How many days in the past 30 have you engaged in illegal activities for profit? How serious do you feel your present legal problems are? (0=Not at all, 4=Extremely) How important to you now is counseling or referral for these legal problems? (0=Not at all, 4=Extremely) How much money did you receive from illegal sources in the past 30 days? These items were standardized and aggregated and yield scores ranging from 0 to 1; higher scores indicate greater problem severity of legal problems. 12 months (post-baseline)
Secondary Family/Social Problems The Family/Social module of the ASI was administered at each timepoint to assess problem severity in this domain, using composite score indices (range 0 to 1); higher scores indicate greater problem severity. 12 months (post-baseline)
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