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Trial record 7 of 4502 for:    Recruiting, Not yet recruiting, Available Studies | "Psychotic Disorders"

Occupational Recovery After First Episode Psychosis

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ClinicalTrials.gov Identifier: NCT03317132
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : October 23, 2017
BC Ministry of Social Development and Social Innovation
Canadian Mental Health Association
Information provided by (Responsible Party):
Fraser Health

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.

Condition or disease Intervention/treatment
Psychosis Behavioral: 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:

  1. 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;
  2. assess changes in health service utilization and related costs as a consequence of improved occupational functioning; and
  3. 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
Allocation: Randomized
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 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Individual Placement and Support
One year of IPS Support
Behavioral: IPS
One year of IPS Support
No Intervention: Treatment as usual
Treatment as usual

Primary Outcome Measures :
  1. Employment attainment [ Time Frame: 1 year ]
    Whether employed (defined as having at least worked one day at a paid job)

Secondary Outcome Measures :
  1. Self-reported Client Service Usage [ Time Frame: 1 year ]
    Change in health service utilization as measured through a Client Service Receipt Inventory

  2. 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

  3. Number of days worked [ Time Frame: 1 year ]
    Number of days in paid employment

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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

Contact: David H Erickson, PhD 6045204663 david.erickson@fraserhealth.ca

Canada, British Columbia
Fraser Health: Royal Columbian Hospital Recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Sponsors and Collaborators
Fraser Health
BC Ministry of Social Development and Social Innovation
Canadian Mental Health Association
Principal Investigator: David H Erickson, PhD Fraser North Early Psychosis Program

Responsible Party: Fraser Health
ClinicalTrials.gov Identifier: NCT03317132     History of Changes
Other Study ID Numbers: 2014-119
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017

Keywords provided by Fraser Health:
Vocational, First-episode psychosis

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders