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Substance Use DisorderMISSION-CJNCT04523337

MISSION-CJ for Justice-Involved Homeless Veterans

A study testing Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice and Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking Peer Support in people with Substance Use Disorder and Mental Health Disorder, run by VA Office of Research and Development at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking - Criminal Justice version (MISSION-CJ) is effective for reducing criminal recidivism and improving other health-related outcomes (substance use, mental health, housing… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice and Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking Peer Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
3 sitesUnited States
Study dates
1 Jul 2021to 28 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (a) are entering a Mental Health Residential Rehabilitation Treatment Program (MH RRTP)
  • (b) were arrested and charged and/or released from incarceration in the past 5 years
  • (c) have a co-occurring substance use and mental health disorder (COD)

Who cannot join

  • The only exclusion criterion is being too cognitively impaired to understand the informed-consent process and other study procedures.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • VA Bedford HealthCare System, Bedford, MA

    Bedford, Massachusetts, 01730-1114

  • Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

    Little Rock, Arkansas, 72205-5484

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1207

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of MISSION-CJ for Justice-Involved Homeless Veterans With Co-Occurring Substance Use and Mental Health Disorders

The purpose of this study is to determine whether Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking - Criminal Justice version (MISSION-CJ) is effective for reducing criminal recidivism and improving other health-related outcomes (substance use, mental health, housing, employment, community integration) among justice-involved, homeless Veterans with a co-occurring substance use and mental health disorder.

Read the detailed description

VHA Mental Health Residential Rehabilitation Treatment Programs (MH RRTPs) serve Veterans with an estimated 50% having criminal justice involvement annually. Justice-involved Veterans (JIVs) receive assistance with their addiction and behavioral health needs, but MH RRTP programs do not directly address their antisocial behaviors and cognitions. Furthermore, MH RRTP discharge is a vulnerable transition and no national transitional approach facilitates Veteran's engagement in prosocial community behaviors that sustain MH RRTP gains, ultimately reducing revolving door service use.

Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice version (MISSION-CJ) is a new case manager and peer delivered team-based treatment for JIVs with a co-occurring substance use and mental health disorder (COD). While MISSION-CJ derives in part from an evidence-based treatment for homeless individuals (MISSION), it includes a new conceptual framework and numerous new and differentiating features for a CJ population including: (1) a treatment planning tool focused on criminogenic needs that monitors progress and tunes service delivery elements; (2) a prosocial treatment curriculum; and (3) tools/resources to address JIVs' legal issues. With MISSION-CJ, this study attempts to change the practice paradigm and transform care for JIVs by moving beyond the current model of linking Veterans to VA care and tracking behavioral health outcomes, to a hybrid treatment/linkage approach that addresses criminogenic needs, supports engagement in VA and non-VA care, and targets recidivism as an outcome-the gold standard for CJ research.

Using a Hybrid Type 1 design, this project will test the effectiveness of MISSION-CJ in a three-site RCT (Bedford, Palo Alto, and Little Rock VAs) with JIVs with a COD, admitted to an MH RRTP, and previously arrested and charged and/or released from incarceration in the past 5-years.

Being tested
Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice, Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking Peer Support
Keywords
Veterans, Co-Occurring Disorder, Homeless Persons, crime, substance-related disorders, mental disorders
Medical subject headings
Substance-Related Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal JusticeBehavioural

    Also called MISSION-CJ

    Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice version (MISSION-CJ) programming targets co-occurring substance use and mental health disorders and other related health outcomes faced by justice-involved homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based services. Patients will receive 2 hours of MISSION-CJ services per week during and after their stay in the mental health residential rehabilitation program (total of 6-months). Services are delivered using a Critical Time Intervention stepdown approach.

  • Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking Peer SupportBehavioural

    Also called MISSION Peer Support

    The MISSION Peer Support Curriculum is rolling entry, and includes 24, one-hour exercises focused on co-occurring substance use and mental health disorders, recovery, and community integration.

Study groups in NCT04523337
Study groupRoleWhat they receive
MISSION-CJExperimentalMaintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice version (MISSION-CJ) programming targets co-occurring substance use and mental health disorders and other related health outcomes faced by justice-involved homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based services.
Receives: Behavioral: Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice
Enhanced Usual CareExperimentalUsual care provided by the mental health residential rehabilitation treatment programs, with patients in both groups are enrolled in, in addition to peer support and community outreach case management. Patients receive 2 Peer Support Curriculum sessions per week (24 sessions total). Patients will receive unstructured community outreach and linkage support while enrolled in the mental health residential rehabilitation program. After discharge, patients will continue to receive 1 hour of weekly linkage support per week.
Receives: Behavioral: Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking Peer Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Criminal recidivism

    Number of arrests based on records from the California and Massachusetts Department of Corrections records; and arrest and incarceration records from the National Crime Information Center.

    Measured: through study completion, on average 15-months

  2. Criminal recidivism

    Number of charges based on records from the California and Massachusetts Department of Corrections records; and arrest and incarceration records from the National Crime Information Center.

    Measured: through study completion, on average 15-months

  3. Criminal Recidivism

    Number of nights in jail or prison based on records from the California and Massachusetts Department of Corrections records; and arrest and incarceration records from the National Crime Information Center.

    Measured: through study completion, on average 15-months

Secondary outcomes (22)
  1. Change in Substance use (Alcohol Use Timeline Follow-back -TLFB)

    Quantity of patients' self-reported alcohol use in the past 90 days. Frequency and quantity will be combined to measure alcohol use severity.

    Measured: Baseline, 6-months, 15-months

  2. Change in Substance use (Alcohol Use Timeline Follow-back -TLFB)

    Frequency of patients' self-reported alcohol use in the past 90 days. Frequency and quantity will be combined to measure alcohol use severity.

    Measured: Baseline, 6-months, 15-months

  3. Change in Substance Use (Illicit Drug Use Timeline Follow back - TLFB)

    Quantity of patients' self-reported illicit drug use in the past 90 days. Frequency and quantity will be combined to measure drug use severity.

    Measured: Baseline, 6-months, 15-months

  4. Change in Substance Use (Illicit Drug Use Timeline Follow back - TLFB)

    Frequency of patients' self-reported illicit drug use in the past 90 days. Frequency and quantity will be combined to measure drug use severity.

    Measured: Baseline, 6-months, 15-months

  5. Change in Trauma Symptoms (PTSD Checklist for DSM-5 - PCL-5)

    Changes in the severity of patients' PTSD symptoms. A total severity score is computed by summing all the items. Scores range from 0-80 with higher scores indicating higher severity.

    Measured: Baseline, 6-months, 15-months

  6. Change in Depression (Patient Health Questionnaire-9 - PHQ-9)

    Changes in the degree of depression severity self-reported by patients. Total scores range from 0-27 with higher scores indicating more severe depression.

    Measured: Baseline, 6-months, 15-months

  7. Change in Mental Health Symptoms (Behavior and Symptom Identification Scale-24 - BASIS-24)

    Changes in the severity of patients' self-reported psychiatric symptoms across 6 subscales (e.g. Depression and Functioning, Interpersonal Relationships, Self-Harm, Psychosis, Substance Abuse, and Emotional Lability) during the past week. Patients score items on a scale of 0-4, and each subscale and mean total score range from 0-4, with higher scores indicating higher levels of severity of symptoms.

    Measured: Baseline, 6-months, 15-months

  8. Change in Recidivism risk (Level of Service Inventory-Revised)

    Changes in the severity of patients' self-reported legal problems. Self-reported arrests, charges, and months incarcerated since the baseline assessment. Total LSI-R scores will be used. Scores range from 0-54 with higher scores indicating greater risk.

    Measured: Baseline, 6-months, 15-months

  9. Change in Medication Adherence Rating Scale (MARS)

    Patients' self-reported compliance with medication. Questions are dichotomous yes/no.

    Measured: Baseline, 6-months, 15-months

  10. Change in Housing Status (Residential Timeline Follow back)

    Quantity of patients' self-reported days homeless in the past 90 days.

    Measured: Baseline, 6-months, 15-months

  11. Change in Housing Status (Residential Timeline Follow back)

    Frequency of patients' self-reported days homeless in the past 90 days.

    Measured: Baseline, 6-months, 15-months

  12. Change in Employment (Maudsley Addiction Profile)

    Quantity of days worked, days absent, and days unemployed in the past 30 days, as self-reported by patients since the baseline assessment.

    Measured: Baseline, 6-months, 15-months

  13. Change in Employment (Maudsley Addiction Profile)

    Frequency of days worked, days absent, and days unemployed in the past 30 days, as self-reported by patients since the baseline assessment.

    Measured: Baseline, 6-months, 15-months

  14. Treatment Engagement (MISSION Treatment Services Tracking Sheet

    Number of services for both VA and non-VA services received (pre- and post-MH RRTP). This includes all possible services offered within MISSION-CJ and EUC (MISSION Peer Support) as well as community linkages. Regarding linkages, the measure quantifies the number of referrals, referral type, and client engagement. Examine change in number of services received during 12 months, collected on a weekly basis.

    Measured: Up to 12 months

  15. Treatment Engagement (MISSION Treatment Services Tracking Sheet)

    Types of services for both VA and non-VA services received (pre- and post-MH RRTP). This includes all possible services offered within MISSION-CJ and Enhanced Usual Care (MISSION Peer Support) as well as community linkages. Examine change in types of services received during 12 months, collected on a weekly basis.

    Measured: Up to 12 months

  16. Change in Treatment Engagement (Alcoholics Anonymous Involvement Scale - AAI)

    Change in patients' self-reported involvement in 12-step groups for substance use. Items are dichotomous yes/no, with yes responses indicating more involvement in 12-step groups. Composite scores range from 0-9 with 9 indicating more involvement in 12-step groups. Patients are also asked to indicate which of the 12-steps they have worked.

    Measured: Baseline, 6-months, 15-months

  17. Change in Treatment Engagement (Alcoholics Anonymous Involvement Scale - AAI)

    Change in patients' self-reported attendance in 12-step groups for substance use over lifetime, and since the previous assessment. Patients report an estimated number of meetings they've attended in the last year, and in their lifetime.

    Measured: Baseline, 6-months, 15-months

  18. Treatment Engagement (Healthcare Continuing Care Utilization)

    Data on SUD/MH continuing care utilization since the prior assessment will be defined as the number of sessions in each setting that the clients attend throughout the follow-up period. Both will be obtained from: (a) CDW, for VA care and (b) service tracking sheets for VA and non-VA health care utilization. For VA care, the electronic medical record data will be obtained from the CDW. CDW data includes both outpatient encounter records (including the type of outpatient care - e.g., from outreach programs, office-based clinical services) and information on inpatient and residential care services used.

    Measured: 12-month period prior to, and ending 15 months after, study enrollment

  19. Treatment Engagement (MH RRTP Completion)

    Healthcare utilization includes both VA and non-VA healthcare services and we will construct several measures. MH RRTP completion will be defined as a regular discharge from the program and determined from the VA's Corporate Data Warehouse (CDW).

    Measured: 12-month period prior to, and ending 15 months after, study enrollment

  20. Change in Community Integration Measure (CIM)

    Patient's self-report perspective of their integration into their home and community are scored on a 5-point scale. A single summary score (range 10-50) is computed by summing each item, with lower scores indicating

    Measured: Baseline, 6-months, 15-months

  21. Change in Antisocial Attitudes (Measures of Criminal Attitudes and Associates - MCAA)

    Changes in patients' self-report of antisocial attitudes on 4 scales: violence, entitlement, antisocial intent, and associates. Responses to MCAA Part B are dichotomous agree/disagree.

    Measured: Baseline, 6-months, 15-months

  22. Change in Affiliations with Antisocial Peers (Measures of Criminal Attitudes and Associates: MCAA)

    Changes in patients' self-report of criminal associations. Part A of the MCAA is intended to quantify criminal associations. In Part A, respondents are asked to recall the four adults in the community with whom they spend the most free time. For each adult, they then indicate how much of their free time is spent in their associate's company. The respondent then answers four questions regarding the degree of criminal involvement of their associates: (a) Has this person ever committed a crime; (b) Does this person have a criminal record; (c) Has this person ever been to jail? and (d) Has this person tried to involve you in a crime? From this information, a measure of criminal associates can be calculated. The Number of Criminal Friends is calculated by totaling the number of friends for which the respondent answers yes to any of the questions of criminal involvement.

    Measured: Baseline, 6-months, 15-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2020
  2. Study start1 Jul 2021
  3. Primary completion27 Feb 2026
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523337
Sponsor's protocol ID
IIR 18-040
Acronym
MISSION-CJ
Status last verified
Mar 2026
First submitted
28 Jul 2020
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shaffer PM, Andre M, Smelson D, Cucciare MA, Bruzios KE, Blonigen DM. Criminogenic risk and suicidality among justice-involved homeless veterans with comorbid mental health and substance use disorders. BMC Public Health. 2026 Feb 4;26(1):809. doi: 10.1186/s12889-026-26250-6.

    PubMed 41639846
  • Bruzios K, Shaffer PM, Blonigen DM, Cucciare MA, Andre M, Byrne T, Smith J, Smelson D. Intervention for Justice-Involved Homeless Veterans With Co-Occurring Substance Use and Mental Health Disorders: Protocol for a Randomized Controlled Hybrid Effectiveness-Implementation Trial. JMIR Res Protoc. 2025 Jul 18;14:e70750. doi: 10.2196/70750.

    PubMed 40680272

Questions about this trial

What is this clinical trial studying?

A study testing Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice and Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking Peer Support in people with Substance Use Disorder and Mental Health Disorder, run by VA Office of Research and Development at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Criminal recidivism (time frame: through study completion, on average 15-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04523337, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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