The Impact of Vocational Rehabilitation on Mentally III Veterans

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00333801
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 75
• Patients Per Site Per Month: 1.3

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder (PTSD)	Behavioral: Vocational Rehabilitation Program (VRP); Behavioral: Individual Placement and Support (IPS)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Impact of Vocational Rehabilitation on Mentally III Veterans
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vocational Rehabilitation Program (VRP) 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); 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; Other Names: Transition work program (TWP)
Experimental: Individual Placement and Support (IPS) 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); 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.; Other Names: Supported emplooyment

Outcome Measures

Primary Outcome Measures

1. Obtain Competitive Employment [1 calendar year]

   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

1. PTSD, Depression, Disability Outcomes [one-year]

   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.

2. Employment Outcomes (Weeks Competitively Employed) [one year]

   Number of weeks employed for any time in a competitive job (not set-aside job)

3. Employment Outcomes (Days Competitively Employed [one year]

   Number of days employed in a competitive job (not set-aside job)

4. Employment Outcomes (Hours Competitively Employed) [one year]

   hours employed in a competitive (not set-aside) job

5. Employment Outcomes (Gross Income Competitive) [one year]

   total gross income (US dollars) from all competitive wages, salary, commissions

6. Employment Outcomes (Total Gross Income From All Sources [one year]

   total gross income from all sources of work including noncompetitive and competitive jobs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tuscaloosa VA Medical Center	Tuscaloosa	Alabama	United States	35404

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Lori L. Davis, MD, Tuscaloosa VA Medical Center, Tuscaloosa, AL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00333801
• Other Study ID Numbers: D4092-I; Promis Number 0052; MIRB 00033; TVAMC 03-19; NCT00260507
• First Posted: Jun 6, 2006
• Last Update Posted: Mar 19, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by US Department of Veterans Affairs: Posttraumatic Stress Disorder; Veterans; Vocational Rehabilitation; Supported Employment; Individual Placement and Support
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Recruitment Details	From 2006 to 2010 Veterans with PTSD at the Tuscaloosa VA Medical Center were enrolled in a 12-month, prospective randomized comparison of IPS Supported Employment and treatment-as-usual Vocational Rehabilitation Program (VRP).
Pre-assignment Detail	100 Veterans were enrolled; 85 were randomized to IPS-SE (n=42) or VRP (n=43) and followed 12-months. 15 participants were excluded: 2 did not have PTSD, 2 lived >100 miles away, 3 withdrew consent, 4 had exclusionary diagnosis, and 4 were not eligible to be enrolled in the VRP. Participants were allowed to continue all other treatments for PTSD.

Arm/Group Title	Vocational Rehabilitation Program (VRP)	Individual Placement and Support (IPS)
Arm/Group Description	VA Vocational Rehabilitation Program (treatment-as-usual) uses 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	Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
Period Title: Overall Study
STARTED	43	42
COMPLETED	35	36
NOT COMPLETED	8	6

Baseline Characteristics

Arm/Group Title	VA Vocational Rehabilitation Program (Treatment-as-usual)	Individual Placement and Support (IPS) Supported Employment	Total
Arm/Group Description	VA Vocational Rehabilitation Program (treatment-as-usual) uses 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.	Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.	Total of all reporting groups
Overall Participants	43	42	85
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.5 (12.5)	39.9 (11.9)	40.2 (12.2)
Sex: Female, Male (Count of Participants)
Female	5 11.6%	5 11.9%	10 11.8%
Male	38 88.4%	37 88.1%	75 88.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized participants were included in the analysis (intent-to-treat)

Arm/Group Title	VA Vocational Rehabilitation Program (Treatment-as-usual)	Individual Placement and Support (IPS) Supported Employment
Arm/Group Description	VA Vocational Rehabilitation Program (treatment-as-usual) uses 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.	Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
Measure Participants	43	42
Number [participants]	12 27.9%	32 76.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VA Vocational Rehabilitation Program (Treatment-as-usual), Individual Placement and Support (IPS) Supported Employment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized participants (intent-to-treat)

Arm/Group Title	VA Vocational Rehabilitation Program (Treatment-as-usual)	Individual Placement and Support (IPS) Supported Employment
Arm/Group Description	VA Vocational Rehabilitation Program (treatment-as-usual) uses 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.	Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
Measure Participants	43	42
CAPS	78.4 (18.3)	77.3 (24)
QIDS-CR	12.2 (4.2)	12.3 (4.5)
CGI-S	5.0 (1.0)	4.8 (0.9)
DTS	82.9 (28.4)	84.9 (28.4)
WHODAS II	81.1 (20.5)	82.6 (19.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VA Vocational Rehabilitation Program (Treatment-as-usual), Individual Placement and Support (IPS) Supported Employment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized participants (intent-to-treat)

Arm/Group Title	VA Vocational Rehabilitation Program (Treatment-as-usual)	Individual Placement and Support (IPS) Supported Employment
Arm/Group Description	VA Vocational Rehabilitation Program (treatment-as-usual) uses 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.	Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
Measure Participants	43	42
Mean (Standard Deviation) [weeks]	6.8 (13.8)	21.6 (17.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VA Vocational Rehabilitation Program (Treatment-as-usual), Individual Placement and Support (IPS) Supported Employment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Cohen's d
	Estimated Value	.93
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Employment Outcomes (Days Competitively Employed
Description	Number of days employed in a competitive job (not set-aside job)
Time Frame	one year

Outcome Measure Data

Analysis Population Description

All randomized participants (intent-to-treat)

Arm/Group Title	VA Vocational Rehabilitation Program (Treatment-as-usual)	Individual Placement and Support (IPS) Supported Employment
Arm/Group Description	VA Vocational Rehabilitation Program (treatment-as-usual) uses 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.	Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
Measure Participants	43	42
Mean (Standard Deviation) [days]	29.3 (61.9)	83.8 (80.6)

5. Secondary Outcome

Title	Employment Outcomes (Hours Competitively Employed)
Description	hours employed in a competitive (not set-aside) job
Time Frame	one year

Outcome Measure Data

Analysis Population Description

All randomized participants (intent-to-treat)

Arm/Group Title	VA Vocational Rehabilitation Program (Treatment-as-usual)	Individual Placement and Support (IPS) Supported Employment
Arm/Group Description	VA Vocational Rehabilitation Program (treatment-as-usual) uses 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.	Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
Measure Participants	43	42
Mean (Standard Deviation) [hours]	236 (494)	656 (661)

6. Secondary Outcome

Title	Employment Outcomes (Gross Income Competitive)
Description	total gross income (US dollars) from all competitive wages, salary, commissions
Time Frame	one year

Outcome Measure Data

Analysis Population Description

All randomized participants (intent-to-treat)

Arm/Group Title	VA Vocational Rehabilitation Program (Treatment-as-usual)	Individual Placement and Support (IPS) Supported Employment
Arm/Group Description	VA Vocational Rehabilitation Program (treatment-as-usual) uses 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.	Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
Measure Participants	43	42
Mean (Standard Deviation) [US dollars]	2,601 (6,009)	9,264 (13,294)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized participants (intent-to-treat)

Arm/Group Title	VA Vocational Rehabilitation Program (Treatment-as-usual)	Individual Placement and Support (IPS) Supported Employment
Arm/Group Description	VA Vocational Rehabilitation Program (treatment-as-usual) uses 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.	Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
Measure Participants	43	42
Mean (Standard Deviation) [US dollars]	3,909 (6,212)	13,449 (9,308)

Adverse Events

Time Frame	Serious adverse events were carefully reviewed with the patients during their participation in the study (1 year), regardless of cause. All serious adverse events were reported to the IRB within 48 hours from the time the PI learned of the event.
Arm/Group Title	VA Vocational Rehabilitation Program (Treatment-as-usual)		Individual Placement and Support (IPS) Supported Employment
Arm/Group Description	VA Vocational Rehabilitation Program (treatment-as-usual) uses 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.		Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
All Cause Mortality
	VA Vocational Rehabilitation Program (Treatment-as-usual)		Individual Placement and Support (IPS) Supported Employment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	VA Vocational Rehabilitation Program (Treatment-as-usual)		Individual Placement and Support (IPS) Supported Employment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/43 (25.6%)		5/42 (11.9%)
Cardiac disorders
Abnormally high blood pressure	1/43 (2.3%)		0/42 (0%)
General disorders
Motor Vehicle Accident complications	1/43 (2.3%)		0/42 (0%)
Medical Stabilization	1/43 (2.3%)		0/42 (0%)
Infections and infestations
Severe Staph Infection	1/43 (2.3%)		0/42 (0%)
Psychiatric disorders
Suicidal Ideation	5/43 (11.6%)		4/42 (9.5%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/43 (2.3%)		0/42 (0%)
COPD	1/43 (2.3%)		0/42 (0%)
Surgical and medical procedures
Surgical procedure	0/43 (0%)		1/42 (2.4%)
Other (Not Including Serious) Adverse Events
	VA Vocational Rehabilitation Program (Treatment-as-usual)		Individual Placement and Support (IPS) Supported Employment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/43 (16.3%)		2/42 (4.8%)
Ear and labyrinth disorders
Hypertrophy adnoids	0/43 (0%)		1/42 (2.4%)
General disorders
Severe migraine headache	1/43 (2.3%)		0/42 (0%)
Neck swelling	1/43 (2.3%)		0/42 (0%)
Infections and infestations
Cyst underarm	1/43 (2.3%)		0/42 (0%)
Injury, poisoning and procedural complications
Injury to finger	1/43 (2.3%)		0/42 (0%)
Alcohol withdrawal	2/43 (4.7%)		0/42 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory distress	0/43 (0%)		1/42 (2.4%)
Chest pain	1/43 (2.3%)		0/42 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.