Clinical trial NCT05388812: Together in Recovery With Veterans Through Employment
Official title: Individual Placement and Support for Veterans With Opioid Use Disorder: A Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Veterans With Opioid Use Disorder
Keywords: Veteran
opioid use disorder
employment
social support
mental health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: eligible and consenting participants will be randomized to either individual placement and support (IPS) or treatment as usual vocational rehabilitation (TAU-VR).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of weeks worked
timeFrame: 15 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 15 months
measure: social support
timeFrame: 15 months
measure: Depression
timeFrame: 15 months
measure: Anxiety
timeFrame: 15 months
measure: Resilience
timeFrame: 15 months
Other outcomes:
measure: suicide risk
timeFrame: 15-months
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center, Birmingham, AL
state: Alabama
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center, Tuscaloosa, AL
state: Alabama
Study officials:
affiliation: Tuscaloosa VA Medical Center, Tuscaloosa, AL
name: Mercy N Mumba, RN
role: PRINCIPAL_INVESTIGATOR
References: