- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03317132
Occupational Recovery After First Episode Psychosis
Study Overview
Detailed Description
This primary objective of this project is to assess, in early psychosis clients, the IPS vocational support model that is the "gold standard" for patients with chronic illness. Specifically, the investigators aim to maximize the chances of employment after recovery from the first acute episode, and provide work experience that will help prevent development of the "chronic mental patient" role. Our primary objective is to assess the degree to which EPI clients randomized to the IPS model will procure competitive work more quickly, and work more days during one year of IPS support, compared to control group patients who continue to receive "treatment-as-usual" vocational services.
There are also several secondary objectives:
- understand fixed and dynamic predictors of vocational success, which may help tailor the IPS model to subpopulations. Predictors that are fixed, but may help in client selection or IPS implementation, include premorbid IQ (intelligence quotient) and previous schooling or employment (respectively). More malleable predictors, where IPS might be offered in conjunction with other interventions, include various neurocognitive abilities and recreational alcohol/drug use;
- assess changes in health service utilization and related costs as a consequence of improved occupational functioning; and
- lay the groundwork for a later project that would assess the longer-term durability of employment and related benefits.
As part of routine clinical care, EPI staff (i.e. case manager or psychiatrist) often query readiness to return to or seek work. For this project, those staff will also query openness to employment support. If the client so wishes, the staff will describe the project, provide a blank copy of the consent form, and gain consent for the RA to contact them after 1-3 days. Since the clients are already well-engaged with our program, the investigators expect substantial success in recruitment and low attrition rates. As noted in the IPS principles, there are minimal restrictions: all clients assigned to the IPS group who interested in working will have access, regardless of job-readiness factors, substance use, symptom severity, cognitive impairments, treatment (non)adherence, or personal presentation.
The measurement strategy includes three sets of assessment interviews from both IPS and TAU clients. The Master's-level RA (research assistant), who will have clinical experience, will collect all data in the first two years. In the third year, a new RA with health economics skills will collect the utilization and social/recreational data, while an unpaid practicum student in Clinical Psychology completes the clinical interviews. Data collection will be blinded, i.e. the RA's will not know whether the client is in the IPS or vocational-service-as-usual group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
New Westminster, British Columbia, Canada, V3L 3W7
- Fraser Health: Royal Columbian Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be a client in the Fraser Health EPI Program,
- want to return to work,
- currently be on a stable therapeutic dose of anti-psychotic medication, and
- have mastery of the English language
Exclusion Criteria:
- No interest in seeking employment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Treatment as usual
|
|
Experimental: Individual Placement and Support
One year of IPS Support
|
One year of IPS Support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Employment attainment
Time Frame: 1 year
|
Whether employed (defined as having at least worked one day at a paid job)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported Client Service Usage
Time Frame: 1 year
|
Change in health service utilization as measured through a Client Service Receipt Inventory
|
1 year
|
Cost related to client service usage
Time Frame: 1 year
|
A cost analysis of client service usage data (see outcome 2) will be conducted by a health economist
|
1 year
|
Number of days worked
Time Frame: 1 year
|
Number of days in paid employment
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David H Erickson, PhD, Fraser North Early Psychosis Program
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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