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PsychosisNCT03317132

Occupational Recovery After First Episode Psychosis

A study testing IPS in people with Psychosis, run by Fraser Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Psychosis
What is being tested?
IPS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 siteCanada
Study dates
Mar 2015to Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • No interest in seeking employment

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Fraser Health: Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W7

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Psychosis
Being tested
IPS
Keywords
Vocational, First-episode psychosis
Medical subject headings
Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPSBehavioural

    One year of IPS Support

Study groups in NCT03317132
Study groupRoleWhat they receive
Individual Placement and SupportExperimentalOne year of IPS Support
Receives: Behavioral: IPS
Treatment as usualNo interventionTreatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Employment attainment

    Whether employed (defined as having at least worked one day at a paid job)

    Measured: 1 year

Secondary outcomes (3)
  1. Self-reported Client Service Usage

    Change in health service utilization as measured through a Client Service Receipt Inventory

    Measured: 1 year

  2. Cost related to client service usage

    A cost analysis of client service usage data (see outcome 2) will be conducted by a health economist

    Measured: 1 year

  3. Number of days worked

    Number of days in paid employment

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2017
  2. Study startMar 2015
  3. Primary completionMar 2020
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03317132
Sponsor's protocol ID
2014-119
Status last verified
Mar 2020
First submitted
22 May 2015
Last updated
23 Jul 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing IPS in people with Psychosis, run by Fraser Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Employment attainment (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.

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