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Supported Employment in a Swedish Context

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ClinicalTrials.gov Identifier: NCT00960024
Recruitment Status : Unknown
Verified August 2009 by Vardalinstitutet The Swedish Institute for Health Sciences.
Recruitment status was:  Active, not recruiting
First Posted : August 17, 2009
Last Update Posted : August 17, 2009
Sponsor:
Information provided by:
Vardalinstitutet The Swedish Institute for Health Sciences

Tracking Information
First Submitted Date  ICMJE August 14, 2009
First Posted Date  ICMJE August 17, 2009
Last Update Posted Date August 17, 2009
Study Start Date  ICMJE April 2008
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supported Employment in a Swedish Context
Official Title  ICMJE Supported Employment for People With Severe Mental Illness in a Swedish Context- A Randomised Controlled Trial
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Psychosis
Intervention  ICMJE
  • Behavioral: Individual Placement and Support-vocational rehabilitation
    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.
  • Behavioral: Vocational rehabilitation available
    The participants are offered vocational rehabilitation available at site
Study Arms  ICMJE
  • Experimental: Individual Placement and Support-vocational rehabilitation
    Intervention: Behavioral: Individual Placement and Support-vocational rehabilitation
  • Active Comparator: Vocational rehabilitation available at study site
    Intervention: Behavioral: Vocational rehabilitation available
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 14, 2009)
120
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00960024
Other Study ID Numbers  ICMJE ulrika
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ulrika Bejerholm, the Vardal Institute, Medical Faculty, Lund University
Study Sponsor  ICMJE Vardalinstitutet The Swedish Institute for Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Staffan Johansson, Assoc Prof Vardalinstitutet The Swedish Institute for Health Sciences
PRS Account Vardalinstitutet The Swedish Institute for Health Sciences
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP