Back to resultsTogether in Recovery With Veterans Through Employment (THRIVE)
Primary Purpose
Veterans With Opioid Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment As Usual Vocational Rehabilitation (TAU-VR)
Individual Placement and Support (IPS)
Sponsored by
About this trial
This is an interventional supportive care trial for Veterans With Opioid Use Disorder focused on measuring Veteran, opioid use disorder, employment, social support, mental health
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 in the past 6 months
- 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
Sites / Locations
- Birmingham VA Medical Center, Birmingham, ALRecruiting
- Tuscaloosa VA Medical Center, Tuscaloosa, ALRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Individual Placement and Support
Treatment As Usual Vocational Rehabilitation (TAU-VR)
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05388812
First Posted
May 19, 2022
Last Updated
February 15, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05388812
Brief Title
Together in Recovery With Veterans Through Employment
Acronym
THRIVE
Official Title
Individual Placement and Support for Veterans With Opioid Use Disorder: A Mixed Methods Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
August 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Veterans With Opioid Use Disorder
Keywords
Veteran, opioid use disorder, employment, social support, mental health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
eligible and consenting participants will be randomized to either individual placement and support (IPS) or treatment as usual vocational rehabilitation (TAU-VR).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individual Placement and Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual Vocational Rehabilitation (TAU-VR)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Treatment As Usual Vocational Rehabilitation (TAU-VR)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Individual Placement and Support (IPS)
Intervention Description
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 Outcome Measure Information:
Title
number of weeks worked
Description
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 Outcome Measure Information:
Title
Quality of Life
Description
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
Title
social support
Description
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
Title
Depression
Description
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
Title
Anxiety
Description
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
Title
Resilience
Description
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 Pre-specified Outcome Measures:
Title
suicide risk
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mercy N Mumba, RN
Phone
(205) 554-3273
Email
Mercy.Mumba@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Lori L Davis, MD AB
Phone
(205) 554-3819
Email
lori.davis@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercy N Mumba, RN
Organizational Affiliation
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham VA Medical Center, Birmingham, AL
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1927
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori L Davis, MD
Phone
205-554-2000
Ext
3819
Email
Lori.Davis@va.gov
First Name & Middle Initial & Last Name & Degree
Mercy N Mumba, PhD
Phone
2055542000
Ext
3274
Email
Mercy.Mumba@ua.edu
Facility Name
Tuscaloosa VA Medical Center, Tuscaloosa, AL
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404-5015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan D Hopkins
Phone
205-554-2000
Ext
2274
Email
Susan.Hopkins@va.gov
First Name & Middle Initial & Last Name & Degree
Darlene S Knox
Phone
(205) 554-3675
Email
Darlene.Servant@va.gov
First Name & Middle Initial & Last Name & Degree
Mercy N Mumba, RN
12. IPD Sharing Statement
Plan to Share IPD
No
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