PsychosisNCT01964092
Effect Evaluation of Individual Placement and Support (IPS)
A study testing Individual Placement and Support and Ordinary employment schemes in people with Psychosis and Substance Abuse, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Psychosis, Substance Abuse, Depression
- What is being tested?
- Individual Placement and Support and Ordinary employment schemes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Psychosis, Substance Abuse, Depression, Anxiety
- Being tested
- Individual Placement and Support, Ordinary employment schemes
- Keywords
- Disability, Individual placement and support, Mental health, Quality of life, Randomized controlled trial, Rehabilitation, Return to work, Supported employment
- Medical subject headings
- Psychotic Disorders, Substance-Related Disorders, Depression, Anxiety 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 SupportBehavioural
Ordinary employment schemesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Individual Placement and Support | Experimental | 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. Receives: Behavioral: Individual Placement and Support |
| Ordinary employment schemes | Active comparator | 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. Receives: Behavioral: Ordinary employment schemes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor Market Participation in Ordinary Paid Employment, or Education.
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.
Measured: 1 year (2016)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Responsible party
- Sponsor
- Investigators
- Silje E Reme, PhD, Study director, NORCE Norwegian Research Centre AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964092
- Sponsor's protocol ID
- IPS-NAV
- Status last verified
- May 2020
- First submitted
- 17 Jul 2013
- Last updated
- 14 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 25403470Fyhn 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.
PubMed 33145494Reme 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.
PubMed 30074050
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Evaluation of Individual Placement and Support (IPS)
- ClinicalTrials.gov ID
- NCT01964092
- Acronym / sponsor ID
- IPS-NAV
- Conditions
- Psychosis, Substance Abuse, Depression, Anxiety
- Keywords
- Disability, Individual placement and support, Mental health, Quality of life, Randomized controlled trial, Rehabilitation, Return to work, Supported employment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Study start
- May 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Posted 14 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Placement and Support | Experimental | Behavioral: Individual Placement and SupportIndividual 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. |
| Ordinary employment schemes | Active comparator | Behavioral: Ordinary employment schemesThe 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. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 | Behavioural | Individual Placement and Support |
| Ordinary employment schemes | Behavioural | Ordinary employment schemes |
Primary outcome
Labor Market Participation in Ordinary Paid Employment, or Education.
Time frame: 1 year (2016)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25403470Sveinsdottir 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.
- Derived from this study: PubMed 33145494Fyhn 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.
- Derived from this study: PubMed 30074050Reme 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 websiteLink provided by the sponsor.
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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.
Silje E Reme, PhD study director
NORCE Norwegian Research Centre AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Placement and Support and Ordinary employment schemes in people with Psychosis and Substance Abuse, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 May 2020. 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 Norway. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Labor Market Participation in Ordinary Paid Employment, or Education. (time frame: 1 year (2016)). 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 NCT01964092, which also lists 3 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 14 May 2020.