Occupational Recovery After First Episode Psychosis
Primary Purpose
Psychosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
IPS
Sponsored by
About this trial
This is an interventional supportive care trial for Psychosis focused on measuring Vocational, First-episode psychosis
Eligibility Criteria
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
Sites / Locations
- Fraser Health: Royal Columbian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Individual Placement and Support
Treatment as usual
Arm Description
One year of IPS Support
Treatment as usual
Outcomes
Primary Outcome Measures
Employment attainment
Whether employed (defined as having at least worked one day at a paid job)
Secondary Outcome Measures
Self-reported Client Service Usage
Change in health service utilization as measured through a Client Service Receipt Inventory
Cost related to client service usage
A cost analysis of client service usage data (see outcome 2) will be conducted by a health economist
Number of days worked
Number of days in paid employment
Full Information
NCT ID
NCT03317132
First Posted
May 22, 2015
Last Updated
July 21, 2020
Sponsor
Fraser Health
Collaborators
Ministry of Social Development and Poverty Reduction, British Columbia, Canadian Mental Health Association
1. Study Identification
Unique Protocol Identification Number
NCT03317132
Brief Title
Occupational Recovery After First Episode Psychosis
Official Title
Occupational Recovery After First Episode Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fraser Health
Collaborators
Ministry of Social Development and Poverty Reduction, British Columbia, Canadian Mental Health Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: To improve employment prospects for people in the chronic stages of mental illness, the gold standard is a program called Individual Placement and Support (IPS). Little research on IPS has been done with clients in the early stages of mental illness. This project aims to assess the incremental effectiveness of the IPS model of employment support over treatment-as-usual in a representative sample of early-psychosis clients . Method: One hundred consenting clients from the Fraser Health Early Psychosis Intervention (EPI) program will be recruited and randomly assigned to receive either one year of IPS support or treatment as usual (i.e., no IPS support but no constraints on the clients to seek other employment or related support themselves). Our primary hypothesis is that the early-psychosis clients receiving the IPS intervention will obtain and maintain more paid employment compared to the TAU (treatment as usual) group. Secondary hypotheses pertain to employment success as a function of both fixed and dynamic factors and assessing the cost-effectiveness of IPS.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Vocational, First-episode psychosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individual Placement and Support
Arm Type
Experimental
Arm Description
One year of IPS Support
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
IPS
Intervention Description
One year of IPS Support
Primary Outcome Measure Information:
Title
Employment attainment
Description
Whether employed (defined as having at least worked one day at a paid job)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Self-reported Client Service Usage
Description
Change in health service utilization as measured through a Client Service Receipt Inventory
Time Frame
1 year
Title
Cost related to client service usage
Description
A cost analysis of client service usage data (see outcome 2) will be conducted by a health economist
Time Frame
1 year
Title
Number of days worked
Description
Number of days in paid employment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Erickson, PhD
Organizational Affiliation
Fraser North Early Psychosis Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fraser Health: Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
12. IPD Sharing Statement
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Occupational Recovery After First Episode Psychosis
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