PsychosisNCT03317132
Occupational Recovery After First Episode Psychosis
A study testing IPS in people with Psychosis, run by Fraser Health at 1 site in Canada.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Individual Placement and Support | Experimental | One year of IPS Support Receives: Behavioral: IPS |
| Treatment as usual | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employment attainment
Whether employed (defined as having at least worked one day at a paid job)
Measured: 1 year
Secondary outcomes (3)
Self-reported Client Service Usage
Change in health service utilization as measured through a Client Service Receipt Inventory
Measured: 1 year
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
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.
- First posted23 Oct 2017
- Study startMar 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Social Development and Poverty Reduction, British Columbia, Canadian Mental Health Association
- Responsible party
- Sponsor
- Investigators
- David H Erickson, PhD, Principal investigator, Fraser North Early Psychosis Program
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Recovery After First Episode Psychosis
- ClinicalTrials.gov ID
- NCT03317132
- Acronym / sponsor ID
- 2014-119
- Conditions
- Psychosis
- Keywords
- Vocational, First-episode psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- Ministry of Social Development and Poverty Reduction, British Columbia, Canadian Mental Health Association
- Study start
- Mar 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Placement and Support | Experimental | Behavioral: IPSOne year of IPS Support |
| Treatment as usual | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No interest in seeking employment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPSOne year of IPS Support | Behavioural | Individual Placement and Support |
Primary outcome
Employment attainment
Time frame: 1 year
Whether employed (defined as having at least worked one day at a paid job)
3 secondary outcomes
Self-reported Client Service Usage
Time frame: 1 year
Cost related to client service usage
Time frame: 1 year
Number of days worked
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H Erickson, PhD principal investigator
Fraser North Early Psychosis Program
1 site in 1 country: see every site and its status.
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.