- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01964092
Effect Evaluation of Individual Placement and Support (IPS)
May 4, 2020 updated by: NORCE Norwegian Research Centre AS
Roughly one third of disability pensions issued in Norway are classified as mental and behavioral disorders.
The proposed study aims to evaluate the effect of an innovative intervention for returning people with moderate to severe mental health disorders to work: Individual Placement and Support (IPS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The current employment schemes offered to this diagnostic group are primarily based on a train-and-place principle with assisted or sheltered employment.
Building on a place-and-train principle, rather, the IPS model of supported employment in real-life competitive work settings has proven largely successful in previous studies, but has never been tested in this group in the Norwegian context.
Study Type
Interventional
Enrollment (Actual)
410
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bergen, Norway, 5014
- Uni Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must be undergoing treatment for moderate to severe mental health problems.
- Participants must have an expressed desire to work.
- Participants must have sufficient Norwegian reading and writing skills.
Exclusion Criteria:
- Participants are not undergoing treatment for moderate to severe mental health problems.
- Participants do not have an expressed desire to work.
- Participants do not have sufficient Norwegian reading and writing skills.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Individual Placement and Support
Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need.
IPS actively facilitates job acquisition and provides ongoing support once the client is employed.
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ACTIVE_COMPARATOR: Ordinary employment schemes
The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Labor Market Participation in Ordinary Paid Employment, or Education.
Time Frame: 1 year (2016)
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Labor market participation is operationalized as being registered in the Norwegian Labour and Welfare Administrations (NAV) State Register of Employers and Employees, and not as a recipient of unemployment or sickness benefits, not receiving work assessment allowance or disability pension with a higher degree of disability than by study inclusion, and registered yearly income.
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1 year (2016)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Silje E Reme, PhD, NORCE Norwegian Research Centre AS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Fyhn T, Ludvigsen K, Reme SE, Schaafsma F. A structured mixed method process evaluation of a randomized controlled trial of Individual Placement and Support (IPS). Implement Sci Commun. 2020 Oct 30;1:95. doi: 10.1186/s43058-020-00083-9. eCollection 2020.
- Reme SE, Monstad K, Fyhn T, Sveinsdottir V, Lovvik C, Lie SA, Overland S. A randomized controlled multicenter trial of individual placement and support for patients with moderate-to-severe mental illness. Scand J Work Environ Health. 2019 Jan 1;45(1):33-41. doi: 10.5271/sjweh.3753. Epub 2018 Aug 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
December 1, 2018
Study Registration Dates
First Submitted
July 17, 2013
First Submitted That Met QC Criteria
October 16, 2013
First Posted (ESTIMATE)
October 17, 2013
Study Record Updates
Last Update Posted (ACTUAL)
May 14, 2020
Last Update Submitted That Met QC Criteria
May 4, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPS-NAV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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