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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03748004
Other study ID # H18-02740
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 14, 2018
Est. completion date May 1, 2020

Study information

Verified date June 2019
Source University of British Columbia
Contact Skye Barbic, PhD
Phone 778 846 6134
Email skye.barbic@ubc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Individual placement support (IPS) is an evidence-based supported employment model for people with severe mental illness, designed to achieve employment in mainstream competitive jobs, either part-time or full-time. The aim of this study is to assess the (i) effectiveness of embedding the (IPS)/Peer Support intervention as part of the primary care centre in securing employment of adults living in the downtown eastside in comparison to the usual treatment WorkBC (control group). (ii) effectiveness of IPS/Peer Support versus the usual treatment (WorkBC) in improving mental illness, quality of life and personal recovery through participation in employment.


Description:

This 18-month mixed methods study consists of an effectiveness multi-site randomized controlled trial of the IPS/peer support intervention plus an embedded qualitative exploration of participants' experiences. All clients receiving primary care services from one DTES clinical site who are employment ready and are not receiving mental health services will be randomly assigned to IPS & Peer Support (experimental group) or WorkBC (control group). Clients are required to participate in the intervention for 16 weeks and will be assessed at baseline, 1-, 3-, and 6-months post study intervention start-date for both groups. Assessments will include the 5 questionnaires administered at baseline which cover the following: Employment Quality, Employment Sustainability, Education Quality and Quantity, Quality of Life, Community Engagement and Clinical significant levels of depression and anxiety.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date May 1, 2020
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Adults, age 19 and over, accessing primary care services at the primary care centre listed in this study (CH Pender Community Health Centre)

- At least one visit to VCH Pender Community Health Centre

- Currently unemployed and not in school or post-secondary training.

- Able to provide informed consent and fluent in English (intervention is currently offered in English only).

- Not hospitalized at the time of recruitment.

Exclusion Criteria:

• Adults, age 19 and over who have access to mental health services

Study Design


Intervention

Behavioral:
IPS/SP
The 72 recruited clients receiving primary care services from one DTES clinical site who are employment ready will be randomly assigned to IPS and Peer Support (experimental group) or WorkBC control group
WorkBC
36 out of the 72 participants who live in the DTES will be randomly assigned to the control group (WorkBC). Participants will be provided with WorkBC employment services.

Locations

Country Name City State
Canada Downtown Community Health Center Vancouver British Columbia
Canada Heatley Community Health Clinic Vancouver British Columbia
Canada Pender Community Health Clinic Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Ministry of Social Development and Poverty Reduction, British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Bond GR, Drake RE. Making the case for IPS supported employment. Adm Policy Ment Health. 2014 Jan;41(1):69-73. doi: 10.1007/s10488-012-0444-6. — View Citation

Campbell K, Bond GR, Drake RE. Who benefits from supported employment: a meta-analytic study. Schizophr Bull. 2011 Mar;37(2):370-80. doi: 10.1093/schbul/sbp066. Epub 2009 Aug 6. — View Citation

Latimer E, Lecomte T. [Individual Placement Support (IPS) for people with severe mental disorders : An approach to favor in Québec?]. Sante Ment Que. 2002;27(1):241-67. French. — View Citation

Sveinsdottir V, Løvvik C, Fyhn T, Monstad K, Ludvigsen K, Øverland S, Reme SE. Protocol for the effect evaluation of Individual Placement and Support (IPS): a randomized controlled multicenter trial of IPS versus treatment as usual for patients with moderate to severe mental illness in Norway. BMC Psychiatry. 2014 Nov 18;14:307. doi: 10.1186/s12888-014-0307-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Securing employment RC will follow-up with all recruited clients who get employed through the IPS/Peer Support intervention and the WorkBC control group. 18 months
Secondary "PHQ-9" Questionnaire to measures level of depression Participants will answer the questions on this questionnaire using a likert scale. A scoring system will calculate the final total number and we will assess mean change from the baseline. The minimum score is 0/27 and the maximum score is 27 18 months
Secondary "GAD7" questionnaire to measure general anxiety disorder Participants will answer the questions on this questionnaire using a likert scale. A scoring system will calculate the final total number and we will assess mean change from the baseline. The minimum score is 0/21. The maximum score is 21. 18 months
Secondary "C-PROM" questionnaire to measure Personal Recovery Participants will answer the questions on this questionnaire using a likert scale. A scoring system will calculate the final total number and we will assess mean change from the baseline. Minimum score is 0/120. Maximum score is 120 18 months
Secondary "REQOL" questionnaire measures Recovery Quality of Life Participants will answer the questions on this questionnaire using a likert scale. A scoring system will calculate the final total number and we will assess mean change from the baseline. Minimum score is 0/64. Maximum score 64. 18 months
Secondary "SWL" questionnaire measures satisfaction with life Participants will answer the questions on this questionnaire using a likert scale. A scoring system will calculate the final total number and we will assess mean change from the baseline. Minimum score is 5/35. Maximum score is 35. 18 months
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