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Behavior, AdaptiveNCT03748004

IPS/Peer Support Intervention in the DTES

A study testing IPS/SP and WorkBC in people with Behavior, Adaptive and Mental Illness, run by University of British Columbia at 3 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Behavior, Adaptive, Mental Illness, Substance Use
What is being tested?
IPS/SP and WorkBC
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
3 sitesCanada
Study dates
14 Nov 2018to 1 May 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Skye Barbic, PhD contact

778 846 6134

skye.barbic@ubc.ca

Canada3 sites, 3 recruiting

  • Downtown Community Health Center

    Vancouver, British Columbia, V6A 1G9

    Smadar Levinson

    Recruiting

  • Heatley Community Health Clinic

    Vancouver, British Columbia, V6A 3G3

    Smadar Levinson, 6046199150

    Recruiting

  • Pender Community Health Clinic

    Vancouver, British Columbia, V6B 1R3

    Smadar Levinson, 6046199150

    Recruiting

Other trials in Canada

About this study

Official title: Optimizing the Employment Outcomes for People Living in the Downtown Eastside

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.

Read the detailed 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.

Being tested
IPS/SP, WorkBC
Keywords
Homeless, Employment
Medical subject headings
Behavior, Mental Disorders, Substance-Related Disorders

What participants receive

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

  • IPS/SPBehavioural

    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

  • WorkBCBehavioural

    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.

Study groups in NCT03748004
Study groupRoleWhat they receive
Adults living in the DTESExperimental36 out of the 72 recruited participants who live in the DTES will be randomly assigned to the intervention group (IPS \& Peer Support). The IPS and Peer Support will actively work and support with each of the 36 participants in seeking employment and education for 16 weeks. IPS/SP will help participants identify their employment and educational goals, identify potential employers, help prepare their resumes and for interviews, and provide ongoing support during the 16 weeks. 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.
Receives: Behavioral: IPS/SP
Individuals 19 yrs or older settled in DTESPlacebo comparator36 out of the 72 recruited participants who live in the DTES will be randomly assigned to the intervention group (IPS \& Peer Support). The IPS and Peer Support will actively work and support with each of the 36 participants in seeking employment and education for 16 weeks. IPS/SP will help participants identify their employment and educational goals, identify potential employers, help prepare their resumes and for interviews, and provide ongoing support during the 16 weeks. 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.
Receives: Behavioral: WorkBC

What is being measured

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

  1. Securing employment

    RC will follow-up with all recruited clients who get employed through the IPS/Peer Support intervention and the WorkBC control group.

    Measured: 18 months

Secondary outcomes (5)

  1. "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

    Measured: 18 months

  2. "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.

    Measured: 18 months

  3. "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

    Measured: 18 months

  4. "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.

    Measured: 18 months

  5. "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.

    Measured: 18 months

Timeline

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

  1. First posted20 Nov 2018
  2. Study start14 Nov 2018
  3. Primary completion30 Nov 2019 (estimated)
  4. Study completion1 May 2020 (estimated)

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
72 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).
Masking
Single blind
Who is masked
Investigator
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03748004
Sponsor's protocol ID
H18-02740
Status last verified
Jun 2019
First submitted
11 Oct 2018
Last updated
17 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is a pilot study (early phase)

Publications

  • Sveinsdottir V, Lovvik C, Fyhn T, Monstad K, Ludvigsen K, Overland 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.

    PubMed 25403470

  • 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.

    PubMed 19661196

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

    PubMed 18253627

  • 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.

    PubMed 23161326

Questions about this trial

What is this clinical trial studying?

A study testing IPS/SP and WorkBC in people with Behavior, Adaptive and Mental Illness, run by University of British Columbia at 3 sites 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 5 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: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

Contact Skye Barbic, PhD (778 846 6134, skye.barbic@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Securing employment (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03748004, which also lists 4 linked publications.

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 17 Jun 2019.

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