Posttraumatic Stress Disorder (PTSD)
Conditions
Keywords
Posttraumatic Stress Disorder, Veterans, Vocational Rehabilitation, Supported Employment, Individual Placement and Support
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).
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.
Interventions
BEHAVIORALVocational 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
BEHAVIORALIndividual 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Employment Outcomes (Weeks Competitively Employed) | one year | Number of weeks employed for any time in a competitive job (not set-aside job) |
| Employment Outcomes (Gross Income Competitive) | one year | total gross income (US dollars) from all competitive wages, salary, commissions |
| Employment Outcomes (Hours Competitively Employed) | one year | hours employed in a competitive (not set-aside) job |
| Employment Outcomes (Total Gross Income From All Sources | one year | total gross income from all sources of work including noncompetitive and competitive jobs |
| Employment Outcomes (Days Competitively Employed | one year | Number of days employed in a competitive job (not set-aside job) |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| VA Vocational Rehabilitation Program (Treatment-as-usual) 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. | 43 |
| Individual Placement and Support (IPS) Supported Employment 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. | 42 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incarcerated | 1 | 2 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Moved to another state | 5 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | VA Vocational Rehabilitation Program (Treatment-as-usual) | Individual Placement and Support (IPS) Supported Employment | Total |
|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 12.5 | 39.9 years STANDARD_DEVIATION 11.9 | 40.2 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 38 Participants | 37 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 43 | 2 / 42 |
| serious Total, serious adverse events | 11 / 43 | 5 / 42 |
Outcome results
Primary
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.
Time frame: 1 calendar year
Population: All randomized participants were included in the analysis (intent-to-treat)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VA Vocational Rehabilitation Program (Treatment-as-usual) | Obtain Competitive Employment | 12 participants |
| Individual Placement and Support (IPS) Supported Employment | Obtain Competitive Employment | 32 participants |
p-value: <0.001Chi-squared
Secondary
Employment Outcomes (Days Competitively Employed
Number of days employed in a competitive job (not set-aside job)
Time frame: one year
Population: All randomized participants (intent-to-treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VA Vocational Rehabilitation Program (Treatment-as-usual) | Employment Outcomes (Days Competitively Employed | 29.3 days | Standard Deviation 61.9 |
| Individual Placement and Support (IPS) Supported Employment | Employment Outcomes (Days Competitively Employed | 83.8 days | Standard Deviation 80.6 |
Secondary
Employment Outcomes (Gross Income Competitive)
total gross income (US dollars) from all competitive wages, salary, commissions
Time frame: one year
Population: All randomized participants (intent-to-treat)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| VA Vocational Rehabilitation Program (Treatment-as-usual) | Employment Outcomes (Gross Income Competitive) | 2,601 US dollars |
| Individual Placement and Support (IPS) Supported Employment | Employment Outcomes (Gross Income Competitive) | 9,264 US dollars |
Secondary
Employment Outcomes (Hours Competitively Employed)
hours employed in a competitive (not set-aside) job
Time frame: one year
Population: All randomized participants (intent-to-treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VA Vocational Rehabilitation Program (Treatment-as-usual) | Employment Outcomes (Hours Competitively Employed) | 236 hours | Standard Deviation 494 |
| Individual Placement and Support (IPS) Supported Employment | Employment Outcomes (Hours Competitively Employed) | 656 hours | Standard Deviation 661 |
Secondary
Employment Outcomes (Total Gross Income From All Sources
total gross income from all sources of work including noncompetitive and competitive jobs
Time frame: one year
Population: All randomized participants (intent-to-treat)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| VA Vocational Rehabilitation Program (Treatment-as-usual) | Employment Outcomes (Total Gross Income From All Sources | 3,909 US dollars |
| Individual Placement and Support (IPS) Supported Employment | Employment Outcomes (Total Gross Income From All Sources | 13,449 US dollars |
Secondary
Employment Outcomes (Weeks Competitively Employed)
Number of weeks employed for any time in a competitive job (not set-aside job)
Time frame: one year
Population: All randomized participants (intent-to-treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VA Vocational Rehabilitation Program (Treatment-as-usual) | Employment Outcomes (Weeks Competitively Employed) | 6.8 weeks | Standard Deviation 13.8 |
| Individual Placement and Support (IPS) Supported Employment | Employment Outcomes (Weeks Competitively Employed) | 21.6 weeks | Standard Deviation 17.7 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
PTSD, Depression, Disability Outcomes
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
Population: All randomized participants (intent-to-treat)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VA Vocational Rehabilitation Program (Treatment-as-usual) | PTSD, Depression, Disability Outcomes | QIDS-CR | 12.2 units on a scale | Standard Deviation 4.2 |
| VA Vocational Rehabilitation Program (Treatment-as-usual) | PTSD, Depression, Disability Outcomes | DTS | 82.9 units on a scale | Standard Deviation 28.4 |
| VA Vocational Rehabilitation Program (Treatment-as-usual) | PTSD, Depression, Disability Outcomes | CGI-S | 5.0 units on a scale | Standard Deviation 1 |
| VA Vocational Rehabilitation Program (Treatment-as-usual) | PTSD, Depression, Disability Outcomes | WHODAS II | 81.1 units on a scale | Standard Deviation 20.5 |
| VA Vocational Rehabilitation Program (Treatment-as-usual) | PTSD, Depression, Disability Outcomes | CAPS | 78.4 units on a scale | Standard Deviation 18.3 |
| Individual Placement and Support (IPS) Supported Employment | PTSD, Depression, Disability Outcomes | WHODAS II | 82.6 units on a scale | Standard Deviation 19.6 |
| Individual Placement and Support (IPS) Supported Employment | PTSD, Depression, Disability Outcomes | CAPS | 77.3 units on a scale | Standard Deviation 24 |
| Individual Placement and Support (IPS) Supported Employment | PTSD, Depression, Disability Outcomes | QIDS-CR | 12.3 units on a scale | Standard Deviation 4.5 |
| Individual Placement and Support (IPS) Supported Employment | PTSD, Depression, Disability Outcomes | CGI-S | 4.8 units on a scale | Standard Deviation 0.9 |
| Individual Placement and Support (IPS) Supported Employment | PTSD, Depression, Disability Outcomes | DTS | 84.9 units on a scale | Standard Deviation 28.4 |
p-value: >0.05Wilcoxon (Mann-Whitney)