Trial Outcomes & Findings for The Impact of Vocational Rehabilitation on Mentally III Veterans (NCT NCT00333801)

NCT ID: NCT00333801

Last Updated: 2024-02-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 1 calendar year
• Results posted on: 2024-02-20

Participant Flow

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).

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.

Participant milestones

Measure	Vocational Rehabilitation Program (VRP) 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) 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.
Overall Study STARTED	43	42
Overall Study COMPLETED	35	36
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Measure	Vocational Rehabilitation Program (VRP) 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) 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.
Overall Study Moved to another state	5	3
Overall Study Lost to Follow-up	2	0
Overall Study Incarcerated	1	2
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

The Impact of Vocational Rehabilitation on Mentally III Veterans

Baseline characteristics by cohort

Measure	VA Vocational Rehabilitation Program (Treatment-as-usual) n=43 Participants 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 n=42 Participants 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 n=85 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 12.5 • n=5 Participants	39.9 years STANDARD_DEVIATION 11.9 • n=7 Participants	40.2 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 calendar year

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

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.

Outcome measures

Measure	VA Vocational Rehabilitation Program (Treatment-as-usual) n=43 Participants 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 n=42 Participants 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.
Obtain Competitive Employment	12 participants	32 participants

SECONDARY outcome

Timeframe: one-year

Population: All randomized participants (intent-to-treat)

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.

Outcome measures

Measure	VA Vocational Rehabilitation Program (Treatment-as-usual) n=43 Participants 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 n=42 Participants 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.
PTSD, Depression, Disability Outcomes CAPS	78.4 units on a scale Standard Deviation 18.3	77.3 units on a scale Standard Deviation 24
PTSD, Depression, Disability Outcomes QIDS-CR	12.2 units on a scale Standard Deviation 4.2	12.3 units on a scale Standard Deviation 4.5
PTSD, Depression, Disability Outcomes CGI-S	5.0 units on a scale Standard Deviation 1.0	4.8 units on a scale Standard Deviation 0.9
PTSD, Depression, Disability Outcomes DTS	82.9 units on a scale Standard Deviation 28.4	84.9 units on a scale Standard Deviation 28.4
PTSD, Depression, Disability Outcomes WHODAS II	81.1 units on a scale Standard Deviation 20.5	82.6 units on a scale Standard Deviation 19.6

SECONDARY outcome

Timeframe: one year

Population: All randomized participants (intent-to-treat)

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

Outcome measures

Measure	VA Vocational Rehabilitation Program (Treatment-as-usual) n=43 Participants 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 n=42 Participants 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.
Employment Outcomes (Weeks Competitively Employed)	6.8 weeks Standard Deviation 13.8	21.6 weeks Standard Deviation 17.7

SECONDARY outcome

Timeframe: one year

Population: All randomized participants (intent-to-treat)

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

Outcome measures

Measure	VA Vocational Rehabilitation Program (Treatment-as-usual) n=43 Participants 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 n=42 Participants 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.
Employment Outcomes (Days Competitively Employed	29.3 days Standard Deviation 61.9	83.8 days Standard Deviation 80.6

SECONDARY outcome

Timeframe: one year

Population: All randomized participants (intent-to-treat)

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

Outcome measures

Measure	VA Vocational Rehabilitation Program (Treatment-as-usual) n=43 Participants 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 n=42 Participants 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.
Employment Outcomes (Hours Competitively Employed)	236 hours Standard Deviation 494	656 hours Standard Deviation 661

SECONDARY outcome

Timeframe: one year

Population: All randomized participants (intent-to-treat)

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

Outcome measures

Measure	VA Vocational Rehabilitation Program (Treatment-as-usual) n=43 Participants 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 n=42 Participants 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.
Employment Outcomes (Gross Income Competitive)	2,601 US dollars Standard Deviation 6,009	9,264 US dollars Standard Deviation 13,294

SECONDARY outcome

Timeframe: one year

Population: All randomized participants (intent-to-treat)

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

Outcome measures

Measure	VA Vocational Rehabilitation Program (Treatment-as-usual) n=43 Participants 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 n=42 Participants 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.
Employment Outcomes (Total Gross Income From All Sources	3,909 US dollars Standard Deviation 6,212	13,449 US dollars Standard Deviation 9,308

Adverse Events

VA Vocational Rehabilitation Program (Treatment-as-usual)

Serious events: 11 serious events

Other events: 7 other events

Deaths: 0 deaths

Individual Placement and Support (IPS) Supported Employment

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	VA Vocational Rehabilitation Program (Treatment-as-usual) n=43 participants at risk 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 n=42 participants at risk 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.
Psychiatric disorders Suicidal Ideation	11.6% 5/43 • 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.	9.5% 4/42 • 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.
Infections and infestations Severe Staph Infection	2.3% 1/43 • 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.	0.00% 0/42 • 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.
Surgical and medical procedures Surgical procedure	0.00% 0/43 • 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.	2.4% 1/42 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.3% 1/43 • 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.	0.00% 0/42 • 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.
General disorders Motor Vehicle Accident complications	2.3% 1/43 • 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.	0.00% 0/42 • 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.
General disorders Medical Stabilization	2.3% 1/43 • 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.	0.00% 0/42 • 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.
Respiratory, thoracic and mediastinal disorders COPD	2.3% 1/43 • 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.	0.00% 0/42 • 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.
Cardiac disorders Abnormally high blood pressure	2.3% 1/43 • 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.	0.00% 0/42 • 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.

Other adverse events

Measure	VA Vocational Rehabilitation Program (Treatment-as-usual) n=43 participants at risk 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 n=42 participants at risk 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.
General disorders Severe migraine headache	2.3% 1/43 • 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.	0.00% 0/42 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/43 • 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.	2.4% 1/42 • 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.
Respiratory, thoracic and mediastinal disorders Chest pain	2.3% 1/43 • 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.	0.00% 0/42 • 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.
Injury, poisoning and procedural complications Injury to finger	2.3% 1/43 • 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.	0.00% 0/42 • 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.
Ear and labyrinth disorders Hypertrophy adnoids	0.00% 0/43 • 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.	2.4% 1/42 • 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.
General disorders Neck swelling	2.3% 1/43 • 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.	0.00% 0/42 • 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.
Injury, poisoning and procedural complications Alcohol withdrawal	4.7% 2/43 • 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.	0.00% 0/42 • 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.
Infections and infestations Cyst underarm	2.3% 1/43 • 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.	0.00% 0/42 • 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.

Additional Information

Lori Davis, MD

Tuscaloosa VA Medical Center

Phone: 205-554-3819

Email: lori.davis@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place