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CompletedNCT04083404Updated Jan 9, 2020Results posted

Investigating Psychosocial Predictors & Employment Outcomes of Enhanced IPS Intervention

An observational study in Psychiatric Disorder, sponsored by Queen Margaret University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-09.

Sponsored by Queen Margaret University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
202
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The cohort study will be undertaken utilising a secondary dataset from an established vocational rehabilitation service (VRS). This service is experienced in providing intervention based on individual placement and support (IPS) with established high fidelity to the model. The team's interventions are also guided by the model of human occupation, (MOHO) and the Worker Role Interview is routinely completed with all patients accessing the service. The Worker Role Interview is a valid reliable measure of psychosocial items measuring of readiness for employment.

The consistency of intervention will be ensured as the service is routinely appraised for fidelity to the IPS by two experts, using a standardised assessment tool the IPS fidelity scale and the team has received ongoing training and regular caseload supervision to integrate evidence-based occupational therapy into practice. The experts appraising the service are independent of both the clinical service and the proposed research.

The established VRS provides an assessment and intervention for people with complex mental health problems. A dataset has been routinely collected over several years which is currently used to evaluate the service.

To address potential limitations of secondary data analysis the researcher has an established relationship with clinicians in the VRS and was involved in the selection of routine measures now used to evaluate the service. It is, therefore, possible to be confident that a consistent and standard dataset is available for analysis. Ongoing training and consultation have been provided by the researcher to the clinical service to ensure the data quality.

Data Collection The data will be managed and transferred by a trained researcher on site at both services.Data will be robustly anonymised prior to transfer. Data will be transferred from NHS secure network to secure network within Queen Margaret University using a secure email service approved by the Department of Health.

The dataset comprises; Research identification (ID) code Gender Age on Admission Ethnicity Marital Status Living situation (alone/shared/supported accommodation) Quintile range of Scottish Index of Multiple Deprivation Educational attainment Previous employment ICD10 Worker role interview items Date of assessment WRI Assesses Abilities \& Limitations WRI Expectation of Success in Work WRI Takes Responsibility WRI Commitment to Work WRI Work-Related Goals WRI Enjoys Work WRI Pursues Interests WRI Appraises Work Expectations WRI Influence of Other Roles WRI Work Habits WRI Daily Routines WRI Adapts Routine to Minimize Difficulties WRI Perception of Physical Work Setting WRI Perception of Family and Peers WRI Perception of Boss and/or Company WRI Perception of Co-workers Employment goal Date of final goal review Outcome of goal (successful/ unsuccessful in attaining employment)

Sample; Based on the guideline of a minimum of 10 events per predictor variable, a sample size of 200 would allow for the robust estimation of 8 variables in the model.

Analysis Plan The collected data will be subject to analysis with the use of multiple logistic regression using the R data analysis software. Multiple logistic regression will allow the construction of models which examine the effects of psychosocial predictors on the probability of a person with complex mental health problems attaining paid employment. Possible confounds which may influence outcomes will be controlled for (e.g. age, gender, educational achievement, history of employment). Interpretation of the analysis will be shared and discussed with clinicians who are expert in their field to ensure that findings are considered from both a statistical significance and clinical significance position.

02

Conditions studied

  • Psychiatric Disorder

Keywords

  • Complex mental health
  • employment
  • Enhanced Individual Placement & Support
  • Model of Human Occupation
  • Worker Role Interview
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 202 is close to the median of 200 across 480 observational studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Queen Margaret University is the lead sponsor of 34 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Complex mental health problems; unemployed

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Lack capacity for informed consent.
  • Refusal or withdrawal of informed consent
  • Incomplete initial assessment data
  • Withdrawal from participation in service prior to intervention
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
202 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Attainment of Employment or Education

    successful attainment of open employment or educational opportunity / unsuccessful

    Time frame: 1day

Other outcomes

  1. Time to Attainment of Employment or Education

    Time to outcome for those successfully attaining employment or education

    Time frame: 1day-69months

07

Results

Posted Jan 9, 2020

Participant flow

Participant flow — Overall Study
MilestoneEnhanced Individual Placement and Support (IPS) Programme
Started202
Completed202
Not completed0

Outcome measures

PrimaryAttainment of Employment or Education

successful attainment of open employment or educational opportunity / unsuccessful

Time frame:
1day
Reported as:
Count of participants · Participants
Attainment of Employment or Education
ParticipantsEnhanced IPS Programme
Attained employment or education128
Did not attain employment or education74
Other pre-specifiedTime to Attainment of Employment or Education

Time to outcome for those successfully attaining employment or education

Time frame:
1day-69months
Reported as:
Median · months
Time to Attainment of Employment or Education
monthsEnhanced IPS Programme
Time to Attainment of Employment or Education8.435 (5.055 to 16.742)

Adverse events

Collected over 1day to 69mths. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enhanced IPS Programme0/202 (0%)0/202 (0%)0/202 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Enhanced IPS Programme
Mean37.4 ± 10.8
Sex: Female, Male
Sex: Female, Male(Participants)Enhanced IPS Programme
Female78
Male124
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Enhanced IPS Programme
Ethnicity — White185
Ethnicity — Other ethnic group17
Marital Status
Marital Status(Participants)Enhanced IPS Programme
Married / de facto relationship33
Single163
missing data6
Social Situation
Social Situation(Participants)Enhanced IPS Programme
living with others97
living alone101
missing data4
Scottish Indices of Multiple Deprivation
Scottish Indices of Multiple Deprivation(Participants)Enhanced IPS Programme
most deprived quintile 138
quintile 235
quintile 333
quintile 432
least deprived quintile 564
Educational Attainment
Educational Attainment(Participants)Enhanced IPS Programme
Did Not Attain School Quals18
Exams from School61
Further Education121
missing data2
Previous Employment
Previous Employment(Participants)Enhanced IPS Programme
Previous employment182
No previous employment20

17 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. PubMed 24030739 ↗
  • 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. PubMed 22660842 ↗
  • 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. PubMed 17006008 ↗
  • 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. PubMed 32641009 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 1, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — all IPD that underlie results in a publication

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04083404
Lead sponsor
Queen Margaret University
Collaborators
NHS Lothian
Responsible party
Susan Prior (Senior Research Fellow, Queen Margaret University) — Principal investigator
First posted
Sep 10, 2019
Start date
Jan 1, 2015
Primary completion
Sep 5, 2018
Completion
Sep 5, 2018
Results posted
Jan 9, 2020
Last update
Jan 9, 2020

Study contacts

Kirsty Forsyth, PhD
study director · Queen Margaret University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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