Supported Employment in a Swedish Context
Primary Purpose
Psychosis
Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Individual Placement and Support-vocational rehabilitation
Vocational rehabilitation available
Sponsored by
About this trial
This is an interventional supportive care trial for Psychosis focused on measuring Vocational rehabilitation, Severe mental illness, Psychosis, Mental Health
Eligibility Criteria
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
Sites / Locations
- The Vardal Institute, Medical Faculty, Lund University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Individual Placement and Support-vocational rehabilitation
Vocational rehabilitation available at study site
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00960024
First Posted
August 14, 2009
Last Updated
August 14, 2009
Sponsor
Vardalinstitutet The Swedish Institute for Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00960024
Brief Title
Supported Employment in a Swedish Context
Official Title
Supported Employment for People With Severe Mental Illness in a Swedish Context- A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Vardalinstitutet The Swedish Institute for Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Vocational rehabilitation, Severe mental illness, Psychosis, Mental Health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individual Placement and Support-vocational rehabilitation
Arm Type
Experimental
Arm Title
Vocational rehabilitation available at study site
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Individual Placement and Support-vocational rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vocational rehabilitation available
Intervention Description
The participants are offered vocational rehabilitation available at site
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Staffan Johansson, Assoc Prof
Organizational Affiliation
Vardalinstitutet The Swedish Institute for Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
The Vardal Institute, Medical Faculty, Lund University
City
Lund
ZIP/Postal Code
221 00
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
24983382
Citation
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.
Results Reference
derived
PubMed Identifier
20815872
Citation
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.
Results Reference
derived
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Supported Employment in a Swedish Context
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