NCT00728325

Brief Summary

This prospective randomized study evaluates the impact of Supportive Employment (SE) compared to standard vocational rehabilitation (VRP) on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic posttraumatic stress disorder (PTSD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2008

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 5, 2008

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

6 years

First QC Date

July 15, 2008

Last Update Submit

December 4, 2013

Conditions

PTSD

Keywords

PTSDVocational RehabilitationSupported Employment

Outcome Measures

Primary Outcomes (1)

  • Using an intent to treat analysis, subjects' maintained employed rate is measured using the Employment Index.

    12 months

Secondary Outcomes (1)

  • Using an intent-to-treat analysis, the change from baseline to endpoint in PTSD symptoms is compared between groups using the Clinician Administered PTSD Scale (CAPS).

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Standard Vocational Rehabilitation (VRP)

Behavioral: Standard Vocational Rehabilitation (VRP)

2

EXPERIMENTAL

Supported Employment (SE)

Behavioral: Supported Employment (SE)

Interventions

Supported Employment (SE)BEHAVIORAL

SE(IPS)involves: a vocational rehabilitation employment specialist who is integrated into the clinical treatment team, carries out all phases of the vocational services, provides predominantly community-based services, provides assertive engagement and outreach, has a case load of ≤ 25 clients; engages in rapid job search, individualized placement in diverse and potentially permanent competitive job(s), ongoing work-based vocational assessment, and assistance in finding subsequent jobs if needed with the view that all jobs are positive learning experiences; continuous time-unlimited follow-along supports to provide vocational services; and weekly group supervision with IPS/VRP team and with IPS supervisor/trainer monthly.

Also known as: Veterans in Vocational Rehabilitation Program
2
Standard Vocational Rehabilitation (VRP)BEHAVIORAL

Standard Vocational Rehabilitation (VRP) includes 1) the Vocational Assistance Program (includes routine prevocational testing and evaluation for all patients upon referral to VRP), 2) Vocational Rehabilitation Therapy that operates under the Compensated Work Therapy/Veterans Industries (CWT) and provides a work regimen with monetary incentives derived from contracts whereby participants are paid on a piece rate basis related to their production, and 3) Transitional Work Program (TWP) that includes a temporary work experience either within the VAMC or in community settings (called the Transitional Work External or TWE).

Also known as: Veterans in Vocational Rehabilitation Program
1

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • signed informed consent
  • diagnosis of PTSD (based on MINI)
  • male or female
  • any race or ethnicity
  • age 19-60
  • currently unemployed
  • interested in competitive employment
  • planning to remain in a 100-mile radius of participating VAMC for the 12- mo duration

You may not qualify if:

  • Lifetime history of severe traumatic brain injury that has resulted in severe cognitive disorder
  • diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder
  • pending active legal charges or expected incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Birmingham VA Medical Center

Birmingham, Alabama, 35233, United States

Location

Tuscaloosa VA Medical Center

Tuscaloosa, Alabama, 35404, United States

Location

Bedford VA Medical Center

Bedford, Massachusetts, 01730, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Employment, Supported

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

EmploymentSocioeconomic FactorsPopulation CharacteristicsRehabilitation, VocationalRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lori L. Davis, M.D.

    Tuscaloosa Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ACOS Research and Development

Study Record Dates

First Submitted

July 15, 2008

First Posted

August 5, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations

US(3)