NCT00333801

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 19, 2015

Completed
Last Updated

February 20, 2024

Status Verified

January 1, 2024

Enrollment Period

4.1 years

First QC Date

June 2, 2006

Results QC Date

November 25, 2014

Last Update Submit

January 24, 2024

Conditions

Keywords

Posttraumatic Stress DisorderVeteransVocational RehabilitationSupported EmploymentIndividual Placement and Support

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 calendar year

Secondary Outcomes (6)

  • PTSD, Depression, Disability Outcomes

    one-year

  • Employment Outcomes (Weeks Competitively Employed)

    one year

  • Employment Outcomes (Days Competitively Employed

    one year

  • Employment Outcomes (Hours Competitively Employed)

    one year

  • Employment Outcomes (Gross Income Competitive)

    one year

  • +1 more secondary outcomes

Study Arms (2)

Vocational Rehabilitation Program (VRP)

ACTIVE COMPARATOR

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

Behavioral: Vocational Rehabilitation Program (VRP)

Individual Placement and Support (IPS)

EXPERIMENTAL

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.

Behavioral: Individual Placement and Support (IPS)

Interventions

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

Also known as: Transition work program (TWP)
Vocational Rehabilitation Program (VRP)

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.

Also known as: Supported emplooyment
Individual Placement and Support (IPS)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404-5015, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

The elements of the study that limit generalizability include the single-site design, the small number of IPS interventionists, low number of women in the sample, and the exclusion of nonveterans.

Results Point of Contact

Title
Lori Davis, MD
Organization
Tuscaloosa VA Medical Center

Study Officials

  • Lori Lynne Davis, MD AB

    Tuscaloosa VA Medical Center, Tuscaloosa, AL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

April 1, 2006

Primary Completion

April 24, 2010

Study Completion

July 26, 2012

Last Updated

February 20, 2024

Results First Posted

March 19, 2015

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations