Who is sponsoring NCT00333801?

NCT00333801 is sponsored by VA Office of Research and Development.

What drugs are being tested in NCT00333801?

Interventions in NCT00333801: Vocational Rehabilitation Program (VRP), Individual Placement and Support (IPS).

What condition does NCT00333801 study?

NCT00333801 studies Posttraumatic Stress Disorder (PTSD).

Is NCT00333801 still recruiting?

NCT00333801 is currently completed. Last updated 20 February 2024.

Are results published for NCT00333801?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-20 · How we verify

NCT00333801

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Impact of Vocational Rehabilitation on Mentally III Veterans

Completed NA Results posted Last updated 20 February 2024

What this trial tests

NA trial testing Vocational Rehabilitation Program (VRP) in Posttraumatic Stress Disorder (PTSD) in 100 participants. Completed in 26 July 2012.

Timeline

1 April 2006

Primary endpoint
24 April 2010

26 July 2012

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 April 2006
Primary completion	24 April 2010
Estimated completion	26 July 2012
Sites	1 location across United States

Drugs / interventions tested

Vocational Rehabilitation Program (VRP)
Individual Placement and Support (IPS)

Conditions studied

Posttraumatic Stress Disorder (PTSD) — all drugs for Posttraumatic Stress Disorder (PTSD) →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 19 to 60, any sex, with Posttraumatic Stress Disorder (PTSD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Obtain Competitive Employment Primary · 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.

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	12
Individual Placement and Support (IPS) Supported Employment	32

PTSD, Depression, Disability Outcomes Secondary · 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

CAPS

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	78.4	± 18.3
Individual Placement and Support (IPS) Supported Employment	77.3	± 24

QIDS-CR

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	12.2	± 4.2
Individual Placement and Support (IPS) Supported Employment	12.3	± 4.5

CGI-S

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	5.0	± 1.0
Individual Placement and Support (IPS) Supported Employment	4.8	± 0.9

DTS

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	82.9	± 28.4
Individual Placement and Support (IPS) Supported Employment	84.9	± 28.4

WHODAS II

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	81.1	± 20.5
Individual Placement and Support (IPS) Supported Employment	82.6	± 19.6

Employment Outcomes (Weeks Competitively Employed) Secondary · one year

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

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	6.8	± 13.8
Individual Placement and Support (IPS) Supported Employment	21.6	± 17.7

Employment Outcomes (Days Competitively Employed Secondary · one year

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

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	29.3	± 61.9
Individual Placement and Support (IPS) Supported Employment	83.8	± 80.6

Employment Outcomes (Hours Competitively Employed) Secondary · one year

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

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	236	± 494
Individual Placement and Support (IPS) Supported Employment	656	± 661

Employment Outcomes (Gross Income Competitive) Secondary · one year

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

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	2,601	± 6,009
Individual Placement and Support (IPS) Supported Employment	9,264	± 13,294

Employment Outcomes (Total Gross Income From All Sources Secondary · one year

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

Group	Value	95% CI
VA Vocational Rehabilitation Program (Treatment-as-usual)	3,909	± 6,212
Individual Placement and Support (IPS) Supported Employment	13,449	± 9,308

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

VA Vocational Rehabilitation Program (Treatment-as-usual)

Serious: 11/43 (26%)

Deaths: —

Individual Placement and Support (IPS) Supported Employment

Serious: 5/42 (12%)

Deaths: —

Serious adverse events (8 terms)

Reaction	System	VA Vocational Rehabilitati…	Individual Placement and S…
Suicidal Ideation	Psychiatric disorders	—	—
Severe Staph Infection	Infections and infestations	—	—
Surgical procedure	Surgical and medical procedures	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Motor Vehicle Accident complications	General disorders	—	—
Medical Stabilization	General disorders	—	—
COPD	Respiratory, thoracic and mediastinal disorders	—	—
Abnormally high blood pressure	Cardiac disorders	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	VA Vocational Rehabilitati…	Individual Placement and S…
Alcohol withdrawal	Injury, poisoning and procedural complications	—	—
Severe migraine headache	General disorders	—	—
Respiratory distress	Respiratory, thoracic and mediastinal disorders	—	—
Chest pain	Respiratory, thoracic and mediastinal disorders	—	—
Injury to finger	Injury, poisoning and procedural complications	—	—
Hypertrophy adnoids	Ear and labyrinth disorders	—	—
Neck swelling	General disorders	—	—
Cyst underarm	Infections and infestations	—	—

Most-reported serious reactions: Suicidal Ideation, Severe Staph Infection, Surgical procedure, Pneumonia, Motor Vehicle Accident complications, Medical Stabilization, COPD, Abnormally high blood pressure.

Data from ClinicalTrials.gov NCT00333801 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other VA Office of Research and Development trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00333801 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 20 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00333801.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing