PsychosisPhase 2NCT00960024
Supported Employment in a Swedish Context
A Phase 2 study testing Individual Placement and Support-vocational rehabilitation and Vocational rehabilitation available in people with Psychosis, run by Vardalinstitutet The Swedish Institute for Health Sciences at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Individual Placement and Support-vocational rehabilitation and Vocational rehabilitation available
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2008to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Additional organic or physical disability to having psychosis
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Vardal Institute, Medical Faculty, Lund University
Lund, 221 00
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- Individual Placement and Support-vocational rehabilitation, Vocational rehabilitation available
- Keywords
- Vocational rehabilitation, Severe mental illness, Psychosis, Mental Health
- Medical subject headings
- Psychotic Disorders, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Placement and Support-vocational rehabilitationBehavioural
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.
Vocational rehabilitation availableBehavioural
The participants are offered vocational rehabilitation available at site
| Study group | Role | What they receive |
|---|---|---|
| Individual Placement and Support-vocational rehabilitation | Experimental | Not described Receives: Behavioral: Individual Placement and Support-vocational rehabilitation |
| Vocational rehabilitation available at study site | Active comparator | Not described Receives: Behavioral: Vocational rehabilitation available |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months, 18 months, and 24 months (6 months after end of intervention)
Secondary outcomes (1)
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
Measured: 6 months, 18 months, and 24 months (6 months after end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startApr 2008
- Primary completionFeb 2011 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Staffan Johansson, Assoc Prof, Study director, Vardalinstitutet The Swedish Institute for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960024
- Sponsor's protocol ID
- ulrika
- Status last verified
- Aug 2009
- First submitted
- 14 Aug 2009
- Last updated
- 17 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24983382Hasson 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.
PubMed 20815872
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supported Employment for People With Severe Mental Illness in a Swedish Context- A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00960024
- Acronym / sponsor ID
- ulrika
- Conditions
- Psychosis
- Keywords
- Vocational rehabilitation, Severe mental illness, Psychosis, Mental Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health SciencesUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Placement and Support-vocational rehabilitation | Experimental | Behavioral: Individual Placement and Support-vocational rehabilitation |
| Vocational rehabilitation available at study site | Active comparator | Behavioral: Vocational rehabilitation available |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Additional organic or physical disability to having psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Placement and Support-vocational rehabilitationIndividual 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. | Behavioural | Individual Placement and Support-vocational rehabilitation |
| Vocational rehabilitation availableThe participants are offered vocational rehabilitation available at site | Behavioural | Vocational rehabilitation available at study site |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2009.
- Derived from this study: PubMed 24983382Bejerholm 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.
- Derived from this study: PubMed 20815872Hasson 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.
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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.
Staffan Johansson, Assoc Prof study director
Vardalinstitutet The Swedish Institute for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Individual Placement and Support-vocational rehabilitation and Vocational rehabilitation available in people with Psychosis, run by Vardalinstitutet The Swedish Institute for Health Sciences at 1 site in Sweden.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
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)). 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 NCT00960024, which also lists 2 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 17 Aug 2009.