Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05388812

Together in Recovery With Veterans Through Employment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Veterans With Opioid Use Disorder Behavior Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Personal Satisfaction Psychological Well-Being Substance-Related Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham VA Medical Center, Birmingham, AL, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Treatment As Usual Vocational Rehabilitation (TAU-VR)

Other

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

Individual Placement and Support (IPS)

Other

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.

Primary outcomes

  1. number of weeks worked

    Time frame: 15 months

    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

Secondary outcomes

  1. Quality of Life

    Time frame: 15 months

    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.

  2. social support

    Time frame: 15 months

    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.

  3. Depression

    Time frame: 15 months

    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.

  4. Anxiety

    Time frame: 15 months

    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.

  5. Resilience

    Time frame: 15 months

    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.

Other outcomes

  1. suicide risk

    Time frame: 15-months

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Individual Placement and Support for Veterans With Opioid Use Disorder: A Mixed Methods Study

Acronym: THRIVE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 24, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.