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The Impact of Vocational Rehabilitation on Mentally III Veterans

Primary Purpose

Posttraumatic Stress Disorder (PTSD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vocational Rehabilitation Program (VRP)
Individual Placement and Support (IPS)
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD) focused on measuring Posttraumatic Stress Disorder, Veterans, Vocational Rehabilitation, Supported Employment, Individual Placement and Support

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or Female Age, greater than or equal to 19 and less than 61. Enrollment in the TVAMC VRP Signed informed consent Chronic post-traumatic stress disorder Any race or ethnic origin Anticipation of remaining in the catchment area for the 12-month study duration Exclusion Criteria: Lifetime history of severe traumatic brain injury that has resulted in severe cognitive impairment History of schizophrenia, schizoaffective, disorder, or bipolar I disorder Pending litigation In need of immediate detoxification.

Sites / Locations

  • Tuscaloosa VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vocational Rehabilitation Program (VRP)

Individual Placement and Support (IPS)

Arm Description

Vocational Rehabilitation Program (VRP). VRP is the treatment as usual, which mostly consisted of transitional work program (TWP) in which client is placed in a set-aside noncompetitive job for time-limited period and then pursues competitive employment at time of discharge from VRP. Limited integration with treatment team and limited follow-along supports that are time-limited.

Inidividual Placement and Support (IPS). IPS Supported Employment involves an IPS specialists working with client to identify job preferences, rapidly begin community-based job search, engage in competitive employment, sustain employment via open-ended IPS follow-along supports, and integrate IPS within the PTSD treatment team.

Outcomes

Primary Outcome Measures

Obtain Competitive Employment
The primary outcome: competitive employment (Yes or No). Competitive employment was defined as a job for regular wages in a setting that was not set aside, or sheltered, that is, the job could be held by people without a mental illness or disability and was not a set-aside job in the VRP. Day labor (babysitting, manual labor by the day, drill, temporary work for family or friends) was not considered competitive employment.

Secondary Outcome Measures

PTSD, Depression, Disability Outcomes
Clinician Administered PTSD Scale for DSM-IV (CAPS) score range 0-136 with higher=more severe; Quick Inventory of Depression Scale - Clinician-rated (QIDS-CR) score range 0-27 with higher=more severe; Clinical Global Impression-Severity (CGI-S) score range 1-7 with higher=more severe; Davidson Trauma Scale (DTS) score range 0-136 with higher=more severe; and World Health Organization Disability Assessment Scale (WHODAS-II) 36-items rated on 5-point scale, from 1 (no difficulty) to 5 (extreme difficulty/cannot do) in 6 domains of life; domain scores are transformed from the total raw score (sum of items) of each domain according to the following formula: Transformed score=[(actual raw score - lowest possible raw score) / (possible raw score range)] x 100.
Employment Outcomes (Weeks Competitively Employed)
Number of weeks employed for any time in a competitive job (not set-aside job)
Employment Outcomes (Days Competitively Employed
Number of days employed in a competitive job (not set-aside job)
Employment Outcomes (Hours Competitively Employed)
hours employed in a competitive (not set-aside) job
Employment Outcomes (Gross Income Competitive)
total gross income (US dollars) from all competitive wages, salary, commissions
Employment Outcomes (Total Gross Income From All Sources
total gross income from all sources of work including noncompetitive and competitive jobs

Full Information

First Posted
June 2, 2006
Last Updated
March 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00333801
Brief Title
The Impact of Vocational Rehabilitation on Mentally III Veterans
Official Title
The Impact of Vocational Rehabilitation on Mentally III Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the impact of Individual Placement and Support (IPS) supported employment (SE) compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD).
Detailed Description
Objectives: to study the impact of Individual Placement and Support (IPS) supported employment (SE) compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD). Research Design: This prospective randomized study evaluates the impact of IPS-SE compared to VRP on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic PTSD who enter the Tuscaloosa VA Medical Center's (TVAMC) vocational rehabilitation program. Methodology: Occupational functioning is determined primarily by whether the veteran can obtain and maintain competitive employment, and, secondarily, by time worked and wages earned for those employed. Veterans who meet inclusion criteria will be randomized to either IPS-SE or VRP. Outcomes will be assessed over a fixed 12-month observation period (beginning at randomization and computed for the entire 12-month observation period) as percent subjects employed at least one week (employed rate), and monthly employment rates (maintained employed rate). In addition, PTSD symptoms and other health-related quality of life measures will be evaluated. This strategy uses all available data during the 1-year period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)
Keywords
Posttraumatic Stress Disorder, Veterans, Vocational Rehabilitation, Supported Employment, Individual Placement and Support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vocational Rehabilitation Program (VRP)
Arm Type
Active Comparator
Arm Description
Vocational Rehabilitation Program (VRP). VRP is the treatment as usual, which mostly consisted of transitional work program (TWP) in which client is placed in a set-aside noncompetitive job for time-limited period and then pursues competitive employment at time of discharge from VRP. Limited integration with treatment team and limited follow-along supports that are time-limited.
Arm Title
Individual Placement and Support (IPS)
Arm Type
Experimental
Arm Description
Inidividual Placement and Support (IPS). IPS Supported Employment involves an IPS specialists working with client to identify job preferences, rapidly begin community-based job search, engage in competitive employment, sustain employment via open-ended IPS follow-along supports, and integrate IPS within the PTSD treatment team.
Intervention Type
Behavioral
Intervention Name(s)
Vocational Rehabilitation Program (VRP)
Other Intervention Name(s)
Transition work program (TWP)
Intervention Description
Vocational Rehabilitation Program (VRP) is a treatment-as-usual method using traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist
Intervention Type
Behavioral
Intervention Name(s)
Individual Placement and Support (IPS)
Other Intervention Name(s)
Supported emplooyment
Intervention Description
Individual Placement and Support (IPS) is an evidence--based model of supported employment that emphasizes rapid job search within client preferences, community job development, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of the IPS specialist within the treatment team.
Primary Outcome Measure Information:
Title
Obtain Competitive Employment
Description
The primary outcome: competitive employment (Yes or No). Competitive employment was defined as a job for regular wages in a setting that was not set aside, or sheltered, that is, the job could be held by people without a mental illness or disability and was not a set-aside job in the VRP. Day labor (babysitting, manual labor by the day, drill, temporary work for family or friends) was not considered competitive employment.
Time Frame
1 calendar year
Secondary Outcome Measure Information:
Title
PTSD, Depression, Disability Outcomes
Description
Clinician Administered PTSD Scale for DSM-IV (CAPS) score range 0-136 with higher=more severe; Quick Inventory of Depression Scale - Clinician-rated (QIDS-CR) score range 0-27 with higher=more severe; Clinical Global Impression-Severity (CGI-S) score range 1-7 with higher=more severe; Davidson Trauma Scale (DTS) score range 0-136 with higher=more severe; and World Health Organization Disability Assessment Scale (WHODAS-II) 36-items rated on 5-point scale, from 1 (no difficulty) to 5 (extreme difficulty/cannot do) in 6 domains of life; domain scores are transformed from the total raw score (sum of items) of each domain according to the following formula: Transformed score=[(actual raw score - lowest possible raw score) / (possible raw score range)] x 100.
Time Frame
one-year
Title
Employment Outcomes (Weeks Competitively Employed)
Description
Number of weeks employed for any time in a competitive job (not set-aside job)
Time Frame
one year
Title
Employment Outcomes (Days Competitively Employed
Description
Number of days employed in a competitive job (not set-aside job)
Time Frame
one year
Title
Employment Outcomes (Hours Competitively Employed)
Description
hours employed in a competitive (not set-aside) job
Time Frame
one year
Title
Employment Outcomes (Gross Income Competitive)
Description
total gross income (US dollars) from all competitive wages, salary, commissions
Time Frame
one year
Title
Employment Outcomes (Total Gross Income From All Sources
Description
total gross income from all sources of work including noncompetitive and competitive jobs
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female Age, greater than or equal to 19 and less than 61. Enrollment in the TVAMC VRP Signed informed consent Chronic post-traumatic stress disorder Any race or ethnic origin Anticipation of remaining in the catchment area for the 12-month study duration Exclusion Criteria: Lifetime history of severe traumatic brain injury that has resulted in severe cognitive impairment History of schizophrenia, schizoaffective, disorder, or bipolar I disorder Pending litigation In need of immediate detoxification.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori L. Davis, MD
Organizational Affiliation
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuscaloosa VA Medical Center
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24708195
Citation
Davis LL, Pilkinton P, Poddar S, Blansett C, Toscano R, Parker PE. Impact of social challenges on gaining employment for veterans with posttraumatic stress disorder: an exploratory moderator analysis. Psychiatr Rehabil J. 2014 Jun;37(2):107-9. doi: 10.1037/prj0000058. Epub 2014 Apr 7.
Results Reference
result
PubMed Identifier
22307881
Citation
Davis LL, Leon AC, Toscano R, Drebing CE, Ward LC, Parker PE, Kashner TM, Drake RE. A randomized controlled trial of supported employment among veterans with posttraumatic stress disorder. Psychiatr Serv. 2012;63(5):464-70. doi: 10.1176/appi.ps.201100340.
Results Reference
result

Learn more about this trial

The Impact of Vocational Rehabilitation on Mentally III Veterans

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