CClinicalTrials.gg
Active, not recruitingNCT05388812THRIVEUpdated Mar 19, 2026

Together in Recovery With Veterans Through Employment

An interventional study of Treatment As Usual Vocational Rehabilitation (TAU-VR) and Individual Placement and Support (IPS) in Veterans With Opioid Use Disorder, sponsored by VA Office of Research and Development. Active, not recruiting at 2 sites in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The purpose of this study is to help Veterans who have opioid use problems with gaining and maintaining meaningful employment. The investigators also want to know employment helps with other aspects of the Veteran's life including starting and staying on necessary medications, mental health needs, and feeling a part of society.

Read the detailed description

The primary aim of this study is to evaluate the employment outcomes of Individual Placement and Support (IPS) compared to Treatment-as-Usual Vocational Rehabilitation (TAU-VR) in 120 Veterans who are recovering from opioid use disorder (OUD) over 15 months. Specifically, the investigators will see which treatment yields more weeks worked in a competitive job with the hypothesis that IPS will result in better outcomes than TAU-VR. The investigators will interview Veterans in both IPS and TAU-VR groups to investigate the contextual barriers and facilitators of implementing vocational services among Veterans with OUD with the aim to provide solutions and leverage facilitators of success as the VHA expands supported employment services to a new priority population. Investigators will evaluate the impact of vocational services on adherence to prescribed treatment and OUD relapse rates. This study is especially timely given the societal impact of the COVID-19 pandemic on employment and occupational functioning.

02

Conditions studied

  • Veterans With Opioid Use Disorder

Keywords

  • Veteran
  • opioid use disorder
  • employment
  • social support
  • mental health
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 123 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • age 19* (\<19 year of age in the state of AL is defined minor)
  • DSM-5 Axis I diagnosis of OUD
  • currently unemployed or underemployed, defined as working \<20hrs/week in a meaningful competitive job for a wage, salary, or commission
  • expression of interest in competitive employment; and willing and able to give informed consent

Exclusion criteria

Exclusion Criteria:

  • current diagnosis of psychotic disorders since these Veterans already can receive IPS in usual care at TVAMC and BVAMC
  • diagnosis of dementia (evidenced in the medical record)
  • presence of current severe and unstable medical condition or terminal illness, that would contraindicate study participation or expose them to an undue risk
  • unlikely that participant can complete the study

    • e.g., expected deployment, incarceration, long-term hospitalization, or relocation from the vicinity
  • active suicidal or homicidal ideation making it unsafe for Veteran to be included
  • current participation in another vocational interventional trial
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    Individual Placement and Support

    The IPS model involves the following important domains: competitive employment, eligibility based on client choice of employment, integration of IPS and treatment team personalized counseling, rapid job search, systematic job development, and time-unlimited and individualized support.

    Other: Individual Placement and Support (IPS)

  • Active comparator
    Treatment As Usual Vocational Rehabilitation (TAU-VR)

    TAU-VR Services may include 1) Compensated Work Therapy-Transitional Work (CWT-TW) assignment in a set-aside, minimum-wage, short-term job, typically in the VA setting (approximately 50% of the Veterans randomized to TW in past studies conducted by the investigators actually engaged in TW assignment) or 2) CWT-Community-Based Employment Services (CWT-CBES) which involves a community job search, placement in a competitive job, with limited follow-along support that typically ends after the Veteran is working in his/her first job

    Other: Treatment As Usual Vocational Rehabilitation (TAU-VR)

Interventions

  • OtherTreatment As Usual Vocational Rehabilitation (TAU-VR)

    TAU-VR Services may include 1) Compensated Work Therapy-Transitional Work (CWT-TW) assignment in a set-aside, minimum-wage, short-term job, typically in the VA setting (approximately 50% of the Veterans randomized to TW in past studies conducted by the investigators actually engaged in TW assignment) or 2) CWT-Community-Based Employment Services (CWT-CBES) which involves a community job search, placement in a competitive job, with limited follow-along support that typically ends after the Veteran is working in his/her first job

  • OtherIndividual Placement and Support (IPS)

    The IPS model involves the following important domains: competitive employment, eligibility based on client choice of employment, integration of IPS and treatment team personalized counseling, rapid job search, systematic job development, and time-unlimited and individualized support.

06

What researchers measure

Primary outcomes

  1. number of weeks worked

    A "week worked" is defined as working either part time or full time in a competitive job during a Sunday to Saturday 7-day window. Competitive employment is defined as a job that pays at least minimum wage or is based on salary or commission, is based in a setting alongside others without disabilities, and is not reserved for people with disabilities

    Time frame: 15 months

Secondary outcomes

  1. Quality of Life

    Veteran quality of life will be measures by a 16-item self-report quality of life scale by Burckhardt and Anderson. Scores range from 16 to 112. Higher numbers mean better quality of life. According to the authors, the average score of a healthy adult is 90. Therefore anything above 90 should be considered good.

    Time frame: 15 months

  2. social support

    the Veterans perceived social support will be measured by the 37-item self-report community assessment inventory by Salari et al. There are four domains: household, (six items), family (10 items), friends 8 items), and community (13 items). scores can be calculated for each domain or on a total scale. for the total scale scores range from. Higher numbers mean higher perceived social support. No specific guidance on what is considered good or poor social support.

    Time frame: 15 months

  3. Depression

    the Veterans depressive symptoms will be measured by the 9-item self-report Patient Health Questionnaire-9 by Pfitzer. Scores range from 1-27. Higher numbers mean more depressive symptoms. 1-4 is considered minimal depression; 5-9 is considered mild depression; 10-14 is considered moderate depression; 15-19 is considered moderately severe depression; and 20-27 is considered severe depression.

    Time frame: 15 months

  4. Anxiety

    the Veterans anxiety will be measured by the 7-item self-report Generalized Anxiety Disorder-7 questionnaire by Spitzer et al. Scores range from zero to 21. Higher numbers mean more anxiety. zero to 4 is considered minimal anxiety; 5-9 is considered mild anxiety; 10-14 is considered moderate anxiety, and 15-21 is considered severe anxiety.

    Time frame: 15 months

  5. Resilience

    the Veterans resilience will be measured by the 6-item self-report Brief Resilience Scale questionnaire by Smith et al. scores range from zero to 30 and then averaged by the number of questions answered. Therefore final scores averages range rom zero to 5. Higher mean scores reflect more resilience. The authors of the questionnaire do not provide any guidance on what is considered high, medium, or low resilience.

    Time frame: 15 months

Other outcomes

  1. suicide risk

    the Veterans suicide risk will be measured by the self-report Columbia Suicide Severity Rating Scale (C-SSRS). The C-SSRS has three subscales' suicidal ideation, intensity of ideation, and suicidal behavior. Suicidal ideation subscale has 5 questions (yes/no). Intensity is rated 1-5 with most severe at 5; frequency is rated zero to 4 (0=not applicable; 1=only one time; 2=a few time; 3=a lot; 4=all the time). Suicidal behavior subscale is divided into actual attempt, interrupted attempt, aborted attempt or self-interrupted attempt, preparatory acts or behavior, and suicide. This is not a scored measure. This is a safety measure.

    Time frame: 15-months

07

Study locations

2 sites
  • Birmingham VA Medical Center, Birmingham, AL
    Birmingham, Alabama 35233-1927, United States
  • Tuscaloosa VA Medical Center, Tuscaloosa, AL
    Tuscaloosa, Alabama 35404-5015, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05388812
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
May 24, 2022
Start date
Dec 16, 2022
Primary completion
Aug 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Mar 19, 2026

Study contacts

Mercy N Mumba, RN
principal investigator · Tuscaloosa VA Medical Center, Tuscaloosa, AL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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