Psychiatric DisorderNCT04083404
Investigating Psychosocial Predictors & Employment Outcomes of Enhanced IPS Intervention
An observational study of Psychiatric Disorder, run by Queen Margaret University.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Disorder
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 5 Sep 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Complex mental health problems; unemployed
Who may be able to join
- self-referred to vocational rehabilitation service
- goal of open paid employment or education
- supported by community mental health teams
- capacity to consent
Who cannot join
- Lack capacity for informed consent.
- Refusal or withdrawal of informed consent
- Incomplete initial assessment data
- Withdrawal from participation in service prior to intervention
About this study
Official title: Investigating Psychosocial Predictors & Employment Outcomes of Enhanced IPS Intervention A Prospective Cohort Study
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.
- Conditions
- Psychiatric Disorder
- Keywords
- Complex mental health, employment, Enhanced Individual Placement & Support, Model of Human Occupation, Worker Role Interview
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Attainment of Employment or Education
successful attainment of open employment or educational opportunity / unsuccessful
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Jan 2015
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Principal investigator, Susan Prior, Queen Margaret University
- Investigators
- Kirsty Forsyth, PhD, Study director, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083404
- Sponsor's protocol ID
- TS0001
- Status last verified
- Dec 2019
- First submitted
- 5 Sep 2019
- Last updated
- 9 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all IPD that underlie results in a publication
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 24030739Bond 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 22660842Forsyth 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 17006008Prior 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 at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Psychosocial Predictors & Employment Outcomes of Enhanced IPS Intervention A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04083404
- Acronym / sponsor ID
- TS0001
- Conditions
- Psychiatric Disorder
- Keywords
- Complex mental health, employment, Enhanced Individual Placement & Support, Model of Human Occupation, Worker Role Interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Posted 9 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Complex mental health problems; unemployed
Key inclusion criteria (4 listed)
- self-referred to vocational rehabilitation service
- goal of open paid employment or education
- supported by community mental health teams
- capacity to consent
Key exclusion criteria (4 listed)
- Lack capacity for informed consent.
- Refusal or withdrawal of informed consent
- Incomplete initial assessment data
- Withdrawal from participation in service prior to intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Attainment of Employment or Education
Time frame: 1day
successful attainment of open employment or educational opportunity / unsuccessful
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24030739Kinoshita 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.
- Background: PubMed 22660842Bond 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.
- Background: PubMed 17006008Forsyth 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.
- Derived from this study: PubMed 32641009Prior 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.
- Individual participant dataSharing planned: No. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty Forsyth, PhD study director
Queen Margaret University
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder, run by Queen Margaret University.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attainment of Employment or Education (time frame: 1day). 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 NCT04083404, 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 9 Jan 2020.