Occupational Recovery After First Episode Psychosis
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|ClinicalTrials.gov Identifier: NCT03317132|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2017
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psychosis||Behavioral: IPS||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Occupational Recovery After First Episode Psychosis|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Individual Placement and Support
One year of IPS Support
One year of IPS Support
No Intervention: Treatment as usual
Treatment as usual
- Employment attainment [ Time Frame: 1 year ]Whether employed (defined as having at least worked one day at a paid job)
- Self-reported Client Service Usage [ Time Frame: 1 year ]Change in health service utilization as measured through a Client Service Receipt Inventory
- 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
- Number of days worked [ Time Frame: 1 year ]Number of days in paid employment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317132
|Canada, British Columbia|
|Fraser Health: Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Principal Investigator:||David H Erickson, PhD||Fraser North Early Psychosis Program|