Clinical Trial: The Impact of Vocational Rehabilitation for Mentally Ill Veterans

This study is not yet open for patient recruitment.
Verified by Tuscaloosa Research & Education Advancement Corporation November 2005

Sponsored by: Tuscaloosa Research & Education Advancement Corporation
Information provided by: Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00260507

Purpose

To study the impact of supported employment (SE) compared to standard vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD).
Condition Intervention
Post Traumatic Stress Disorder
 Procedure: Vocational Rehabilitation vs. Supportive Employment

MedlinePlus related topics:  Post-Traumatic Stress Disorder

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment

Official Title: The Impact of Vocational Rehabilitation on Mentally Ill Veterans

Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:
Primary Outcomes: Compared with standard VRP, veterans in SE will be less likely to drop-out of : i) a vocational rehabilitation program, ii) addiction treatment (if applicable), and iii) mental health treatment (if applicable).
Secondary Outcomes: (1) Compared with standard VRP, veterans in SE will have i) a greater likelihood of attaining and maintaining employment, ii) longer duration of sobriety, and iii) improved psychiatric symptomatology and neurocognitive function.; (2) Compared with standard VRP, veterans in SE will have improved: i) physical functioning; ii) mental functioning; and iii) overall quality of life.; (3) Compared with standard VRP, veterans in SE will have improved: i) physical functioning; ii) mental functioning; and iii) overall quality of life.
Expected Total Enrollment:  200

Study start: January 2006;  Expected completion: January 2009

Objective: To study the impact of supported employment (SE) compared to standard vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD).

Research Design: This prospective randomized study evaluates the impact of SE compared to VRP on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic posttraumatic stress disorder who enter the Tuscaloosa VA Medical Center’s (TVAMC) vocational rehabilitation program Methodology: Specifically, we compare SE versus VRP with respect to whether or not patients are less likely to drop out of vocational rehabilitation, addictions treatment, and psychiatric medications treatments (treatment outcomes). We also examine whether SE patients compared to their VRP counterparts obtain competitive employment, improve sobriety, and lower psychiatric symptoms (health outcomes). We also examine whether SE patients compared to their VRP counterparts, have better health functioning and improved quality of life (quality-of-life outcomes). Finally, we examine the extent to which SE leads to higher health care costs and to compare any improved outcomes with the expected higher costs (value).

Clinical Significance: The proposed study will produce a rich database allowing investigators to explore other questions. A major focus is to identify predictors of outcomes, risk factors for early dropout, and major barriers to continuous treatment (risk factors). The study also explores the relationship between dropping-out of VRP and clinical outcomes (drop-out effects). The study explores differences in clinical outcomes between SE and VRP for patients who remain in treatment (SE effects). The latter findings explore whether SE may have more of an impact on clinical outcomes than merely keeping patients in treatment.

Understanding the predictors of outcome and potential for early drop-out from VCR and the impact of SE will lead to better delivery of services for veterans with chronic posttraumatic stress disorder.

Findings: This protocol was resubmitted to The Rehabilitation Research and Development Service (VA RR&D) for Merit review in June, 2005 after extensive revisions were made. In regard to the previously enrolled subjects, the entire baseline assessment was conducted on all 9 subjects (100%). Seven of the nine subjects are eligible for randomization (78%). One subject was a screen failure due to Axis I diagnosis of psychosis NOS and hallucinogen hallucinosis and one subject was incarcerated prior to finishing screening. Four of the patients were randomly assigned to VRP-ICM, and the other three were assigned to VRP without ICM condition. Four patients (57%) had PTSD diagnosis. Patient compliance with requirements through the six months of the pilot study was very good in spite of the fact only three patients (33%) successfully completed the VRP. Six patients (86%) completed the study (6-mo assessments). One patient (14%) exited after month one, due to legal problems (court appearance in a remote county and loss of driver’s license). Two patients obtained full-time competitive employment after VRP discharge, both in the control group. Due to the small sample size, the change in rating scale scores was not statistically or clinically meaningful. These data will not be used in the final study analysis due to the extensive changes that have been made to the protocol.

Eligibility

Ages Eligible for Study:  19 Years   -   70 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion • Male or female • Age ≥19 • Enrollment in the TVAMC VRP • Signed informed consentChronic posttraumatic stress disorder • Any race or ethic origin • Anticipation of remaining in the catchment area for the 12-month study duration

Exclusion

• Lifetime history of severe traumatic brain injury that has resulted in severe cognitive impairment • History of schizophrenia, schizoaffective disorder, or bipolar I disorder

-

Exclusion Criteria:

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00260507

Lori L Davis, MD      205-554-2000  Ext. 3819    lori.davis@va.gov
Jason M Newell, MSW      205-554-2000  Ext. 3574    jason.newell@va.gov

Alabama
      Tuscaloosa VA Medical Center, Tuscaloosa,  Alabama,  35404,  United States

Study chairs or principal investigators

Lori L. Davis, MD,  Principal Investigator,  Psychiatrist/Coordinator of Research and Development   

More Information

Publications

Marshall M, Crowther R, Almaraz-Serrano A, Creed F, Sledge W, Kluiter H, Roberts C, Hill E, Wiersma D, Bond GR, Huxley P, Tyrer P. Systematic reviews of the effectiveness of day care for people with severe mental disorders: (1) acute day hospital versus admission; (2) vocational rehabilitation; (3) day hospital versus outpatient care. Health Technol Assess. 2001;5(21):1-75. Review.

Study ID Numbers:  D40921
Last Updated:  December 8, 2005
Record first received:  November 29, 2005
ClinicalTrials.gov Identifier:  NCT00260507
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10

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