NCT04083404

Brief Summary

The purpose of this cohort study, using an existing database, is to seek to describe the relationship between psychosocial factors (independent variables) and employment outcomes (dependent variables) in a population of people with complex mental health problems receiving evidence-based supported employment (EBSE) augmented with theory-driven occupational therapy interventions. The intention is to understand the predictive nature of psychosocial factors on the positive outcome of success in achieving paid employment. The Worker role interview (WRI) is routinely used in the research site; an National health Service (NHS) occupational therapy led vocational rehabilitation delivering EBSE service for people with complex mental health problems. An existing database of initial assessments and employment outcomes is available for investigation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

January 9, 2020

Completed
Last Updated

January 9, 2020

Status Verified

December 1, 2019

Enrollment Period

3.7 years

First QC Date

September 5, 2019

Results QC Date

September 19, 2019

Last Update Submit

December 18, 2019

Conditions

Keywords

Complex mental healthemploymentEnhanced Individual Placement & SupportModel of Human OccupationWorker Role Interview

Outcome Measures

Primary Outcomes (1)

  • Attainment of Employment or Education

    successful attainment of open employment or educational opportunity / unsuccessful

    1day

Other Outcomes (1)

  • Time to Attainment of Employment or Education

    1day-69months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Complex mental health problems; unemployed

You may qualify if:

  • self-referred to vocational rehabilitation service
  • goal of open paid employment or education
  • supported by community mental health teams
  • capacity to consent

You may not qualify if:

  • Lack capacity for informed consent.
  • Refusal or withdrawal of informed consent
  • Incomplete initial assessment data
  • Withdrawal from participation in service prior to intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Kinoshita Y, Furukawa TA, Kinoshita K, Honyashiki M, Omori IM, Marshall M, Bond GR, Huxley P, Amano N, Kingdon D. Supported employment for adults with severe mental illness. Cochrane Database Syst Rev. 2013 Sep 13;2013(9):CD008297. doi: 10.1002/14651858.CD008297.pub2.

    PMID: 24030739BACKGROUND
  • Bond GR, Peterson AE, Becker DR, Drake RE. Validation of the Revised Individual Placement and Support Fidelity Scale (IPS-25). Psychiatr Serv. 2012 Aug;63(8):758-63. doi: 10.1176/appi.ps.201100476.

    PMID: 22660842BACKGROUND
  • Forsyth K, Braveman B, Kielhofner G, Ekbladh E, Haglund L, Fenger K, Keller J. Psychometric properties of the Worker Role Interview. Work. 2006;27(3):313-8.

    PMID: 17006008BACKGROUND
  • Prior S, Maciver D, Aas RW, Kirsh B, Lexen A, van Niekerk L, Irvine Fitzpatrick L, Forsyth K. An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation (MOHO); a prospective cohort study. BMC Psychiatry. 2020 Jul 8;20(1):361. doi: 10.1186/s12888-020-02745-3.

MeSH Terms

Conditions

Mental Disorders

Results Point of Contact

Title
Dr Susan Prior
Organization
Queen Margaret University

Study Officials

  • Kirsty Forsyth, PhD

    Queen Margaret University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 10, 2019

Study Start

January 1, 2015

Primary Completion

September 5, 2018

Study Completion

September 5, 2018

Last Updated

January 9, 2020

Results First Posted

January 9, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

all IPD that underlie results in a publication