- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00960024
Supported Employment in a Swedish Context
August 14, 2009 updated by: Vardalinstitutet The Swedish Institute for Health Sciences
Supported Employment for People With Severe Mental Illness in a Swedish Context- A Randomised Controlled Trial
This project aims at generating evidence of a work-rehabilitation strategy that benefits the people with severe mental illness (SMI) who want to work, increase their sense of well-being and integration in society, decrease their financial dependence and experiences of stigma and discrimination.
The project is likely to help form the basis of how to implement the evidence based supported employment (SE)-model, Individual Placement and Support model (IPS), in a Swedish work-rehabilitation context.
In the long run, evidence of SE in a Swedish context could help to decrease the period of sick-leave and increase fulfilling and productive lifestyles among people with severe mental illness.
In all, the effectiveness of SE can improve the quality of life for the target group, the quality in mental health care rehabilitation and decrease the costs of treatment and care.
Study Overview
Status
Unknown
Conditions
Detailed Description
Evidence-based mental health treatment and scientific support has gained increased attention in Sweden.
The Swedish National Board of Health and Welfare emphasizes the importance of Supported Employment.
Especially since there are no study in Sweden that has an RCT-design, and that fully take on the responsibility of implementing a SE- intervention in concordance with the evidence based version of SE in mental health care, the Individual Placement and Support model, IPS.
Internationally, SE according to IPS is an evidence-based approach to help people with SMI find and keep employment.
RCT and quasi-experimental studies showed that IPS (Place-Then-Train), is more effective than the traditional stepwise vocational rehabilitation model(Train-Then-Place.
However, there is no research evidence if the SE/IPS will function in relation to a Swedish benefit and health system and work-rehabilitation context.
This intervention project will therefore not only study the effects of vocational and health-related outcomes and experiences, but also study the implementation of SE/IPS, its feasibility and level of fidelity in a Swedish context.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
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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Lund, Sweden, 221 00
- The Vardal Institute, Medical Faculty, Lund University
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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
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- People with Severe mental illness, which mostly means having a diagnosis of psychosis
- Communicate in Swedish
- Express interest in working in the near future
- Have professional care or support from psychiatric clinic
- Attend to a SE-introductory meeting
Exclusion Criteria:
- Additional organic or physical disability to having psychosis
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Individual Placement and Support-vocational rehabilitation
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Individual contact with an employment specialist, who works according to 7 core principles according to SE/IPS. 1) competitive employment as primary goal, 2) rapid job search, 3) eligibility based on client choice, 4) job search based on to client preferences, 5) integration with the mental health care team, 6) availability of time unlimited support at work 7) benefits counseling.
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Active Comparator: Vocational rehabilitation available at study site
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The participants are offered vocational rehabilitation available at site
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To determine the effectiveness of SE/IPS in terms of vocational outcomes, such as employment rate, monthly income, job-tenure and working hours compared to stepwise rehabilitation available, for people with SMI in a Swedish context
Time Frame: 6 months, 18 months, and 24 months (6 months after end of intervention)
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6 months, 18 months, and 24 months (6 months after end of intervention)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To determine the effectiveness of a SE in terms health-related and functional outcomes, such as symptoms, perceived discrimination, empowerment, work-readiness, self-image, level of social and community participation, and quality of life
Time Frame: 6 months, 18 months, and 24 months (6 months after end of intervention)
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6 months, 18 months, and 24 months (6 months after end of intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Staffan Johansson, Assoc Prof, Vardalinstitutet The Swedish Institute for Health Sciences
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
- Bejerholm U, Areberg C, Hofgren C, Sandlund M, Rinaldi M. Individual placement and support in Sweden - a randomized controlled trial. Nord J Psychiatry. 2015 Jan;69(1):57-66. doi: 10.3109/08039488.2014.929739. Epub 2014 Jul 1.
- Hasson H. Systematic evaluation of implementation fidelity of complex interventions in health and social care. Implement Sci. 2010 Sep 3;5:67. doi: 10.1186/1748-5908-5-67.
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
April 1, 2008
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
August 14, 2009
First Submitted That Met QC Criteria
August 14, 2009
First Posted (Estimate)
August 17, 2009
Study Record Updates
Last Update Posted (Estimate)
August 17, 2009
Last Update Submitted That Met QC Criteria
August 14, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ulrika
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