NCT03317132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2015

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 23, 2020

Status Verified

March 1, 2020

Enrollment Period

5 years

First QC Date

May 22, 2015

Last Update Submit

July 21, 2020

Conditions

Keywords

Vocational, First-episode psychosis

Outcome Measures

Primary Outcomes (1)

  • Employment attainment

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

    1 year

Secondary Outcomes (3)

  • Self-reported Client Service Usage

    1 year

  • Cost related to client service usage

    1 year

  • Number of days worked

    1 year

Study Arms (2)

Individual Placement and Support

EXPERIMENTAL

One year of IPS Support

Behavioral: IPS

Treatment as usual

NO INTERVENTION

Treatment as usual

Interventions

IPSBEHAVIORAL

One year of IPS Support

Individual Placement and Support

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No interest in seeking employment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fraser Health: Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • David H Erickson, PhD

    Fraser North Early Psychosis Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2015

First Posted

October 23, 2017

Study Start

March 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

July 23, 2020

Record last verified: 2020-03

Locations