Severe Mental DisorderIPSBODONCT04179877
A Naturalistic Controlled Trial of Individual Placement and Control in Bodø
A study testing IPS in people with Severe Mental Disorder, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
The investigators aim to test the effectiveness of Individual Placement and Support (IPS) on 1. employment, 2. welfare dependency, and 3. public-sector health care utilization. This is a naturalistic controlled trial, where one municipality (Bodø in Norway) with about 50000 inhabitants get access to IPS services in… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Severe Mental Disorder
- What is being tested?
- IPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2013to 31 Dec 2022
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Severe mental illness
- Work assessment allowance
Who cannot join
- Disability benefit
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to test the effectiveness of Individual Placement and Support (IPS) on
- employment,
- welfare dependency, and
- public-sector health care utilization.
Read more
This is a naturalistic controlled trial, where one municipality (Bodø in Norway) with about 50000 inhabitants get access to IPS services in public sector mental health services during the period 2013-2016. The target group for the intervention is patients with severe mental illness (SMI) in the age group 18-40 at time of treatment. Patients already receiving lifelong disability benefits will be excluded.
The control group will be an average of 10 municipalities in Norway without IPS services.
Data for outcomes will be based on public registries available for research.
Read the detailed description
The investigators aim test the hypotheses that Individual Placement and Support (IPS) is effective in
- increasing employment,
- reducing welfare dependency, and
- reducing public-sector health care utilization.
This is a naturalistic controlled trial, where one municipality (Bodø in Norway) with about 50000 inhabitants get access to IPS services in public sector mental health services during the period 2013-2016. The follow-up period will last until 2022. The target group for the intervention is patients with severe mental illness (SMI) in the age group 18-40 at time of treatment, with an ambition of 200 received IPS services. The investigators aim to study the effectiveness on the societal (not individual) level, assuming spill-over effects within Bodø municipality as a result of system changes in the treatment municipality (Bodø). Patients already receiving lifelong disability benefits will be excluded. The control group will be 10 similar municipalities in Norway without IPS services and will be chosen on the basis of similarities in economy, demography and geography and collected from publicly available information. Approximately 77000 subjects will be enrolled in this study; 7000 subjects from Bodø municipality and 70000 from the other 10 municipalities (the control group).
Data for outcomes will be based on public registries available for research. Outcome operationalizations are:
- Employment will be based on registry data from tax records with information both on employment (yes/no and period) and taxable income (NOK).
- Welfare dependency will be based on registry data including rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits. These will be analysed separate and combined, and the main hypothesis will be based on the latter.
- Health care utilization will be based on data from the Norwegian Patient Register. Data for in-patient and out-patients treatments for mental illness and other (separate analyses) will be used. These will be analysed separate and combined, and the main hypothesis will be based on the first.
The data will be analyzed in two rounds; first in 2019, and a follow-up analysis in 2022. A difference-in-difference approach will be used to measure the effects.
- Conditions
- Severe Mental Disorder
- Being tested
- IPS
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPSBehavioural
Occupational rehabilitation and support Integrated with clinical treatment
| Study group | Role | What they receive |
|---|---|---|
| Individual placement and support | Experimental | Group of patients receiving IPS to increase workforce participation. Receives: Behavioral: IPS |
| Control | No intervention | Group of patients receiving treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term welfare dependency
Rates of welfare dependency (rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits) in Bodø (intervention municipality) will be compared to rates of welfare dependency in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities) using Norwegian registry data.
Measured: 15 years after implementation of IPS-services in Bodø (intervention municipality)
Secondary outcomes (6)
Employment rate
Rates of employment in Bodø (intervention municipality) will be compared to employment rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). The measurement tool will be Norwegian registry data from tax records with information both on employment (yes/no and time period) and taxable income (NOK).
Measured: 3 years after implementation of IPS-services in Bodø, Norway
Employment rate
Rates of employment in Bodø (intervention municipality) will be compared to employment rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). The measurement tool will be Norwegian registry data from tax records with information both on employment (yes/no and time period) and taxable income (NOK).
Measured: 7 years after implementation of IPS-services in Bodø, Norway (intervention municipality)
Welfare dependency rate
Welfare dependency rates (rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits) in Bodø (intervention group/municipality) will be compared to 10 similar municipalities without IPS-services (control groups/municipalities).
Measured: 3 years after implementation of IPS-services in Bodø (intervention municipality)
Welfare dependency rate
Rates of welfare dependency (rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits) in Bodø (intervention municipality) will be compared to rates of welfare dependency in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities) using Norwegian registry data.
Measured: 7 years after implementation of IPS-services in Bodø (intervention municipality)
Rates of treatments for mental illness
Rates of health care utilization in Bodø (intervention municipality) will be compared to health care utilization rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). Health care utilization will be based on data from the Norwegian Patient Register. We will use data for in-patient and out-patients treatments for mental illness and other (separate analyses), collected from the Norwegian Patient Register as a measurement tool. These will be analysed separate and combined, and the main hypothesis will be based on the first.
Measured: 3 years after implementation of IPS-services in Bodø (intervention municipality)
Rates of treatments for mental illness
Rates of health care utilization in Bodø (intervention municipality) will be compared to health care utilization rates in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities). Health care utilization will be based on data from the Norwegian Patient Register. We will use data for in-patient and out-patients treatments for mental illness and other (separate analyses), collected from the Norwegian Patient Register as a measurement tool. These will be analysed separate and combined, and the main hypothesis will be based on the first.
Measured: 7 years after implementation of IPS-services in Bodø (intervention municipality)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Jan 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Naturalistic controlled trial with one municipality (Bodø) as treatment group and 10 similar municipalities without IPS services as controls.
- Masking
- None (open label)
- Enrolment
- 77,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Nordlandssykehuset HF, University of Tromso, London School of Economics and Political Science, University of Melbourne, St George's Healthcare NHS Trust, The University of New South Wales
- Responsible party
- Sponsor
- Investigators
- Arnstein Mykletun, Prof PsyD, Principal investigator, Norwegian IPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179877
- Sponsor's protocol ID
- IPSBODO
- Acronym
- IPSBODO
- Status last verified
- Nov 2019
- First submitted
- 30 Nov 2018
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Naturalistic Controlled Trial of Individual Placement and Control in Bodø
- ClinicalTrials.gov ID
- NCT04179877
- Acronym / sponsor ID
- IPSBODO / IPSBODO
- Conditions
- Severe Mental Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77,000 participants (estimated)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Nordlandssykehuset HF, University of Tromso, London School of Economics and Political Science, University of Melbourne, St George's Healthcare NHS Trust, The University of New South Wales
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Nov 2019 (actual)
- 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.
The investigators aim to test the effectiveness of Individual Placement and Support (IPS) on
- employment,
- welfare dependency, and
- public-sector health care utilization.
This is a naturalistic controlled trial, where one municipality (Bodø in Norway) with about 50000 inhabitants get access to IPS services in public sector mental health services during the period 2013-2016. The target group for the intervention is patients with severe mental illness (SMI) in the age group 18-40 at time of treatment. Patients already receiving lifelong disability benefits will be excluded.
The control group will be an average of 10 municipalities in Norway without IPS services.
Data for outcomes will be based on public registries available for research.
Detailed description
The investigators aim test the hypotheses that Individual Placement and Support (IPS) is effective in
- increasing employment,
- reducing welfare dependency, and
- reducing public-sector health care utilization.
This is a naturalistic controlled trial, where one municipality (Bodø in Norway) with about 50000 inhabitants get access to IPS services in public sector mental health services during the period 2013-2016. The follow-up period will last until 2022. The target group for the intervention is patients with severe mental illness (SMI) in the age group 18-40 at time of treatment, with an ambition of 200 received IPS services. The investigators aim to study the effectiveness on the societal (not individual) level, assuming spill-over effects within Bodø municipality as a result of system changes in the treatment municipality (Bodø). Patients already receiving lifelong disability benefits will be excluded. The control group will be 10 similar municipalities in Norway without IPS services and will be chosen on the basis of similarities in economy, demography and geography and collected from publicly available information. Approximately 77000 subjects will be enrolled in this study; 7000 subjects from Bodø municipality and 70000 from the other 10 municipalities (the control group).
Data for outcomes will be based on public registries available for research. Outcome operationalizations are:
- Employment will be based on registry data from tax records with information both on employment (yes/no and period) and taxable income (NOK).
- Welfare dependency will be based on registry data including rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits. These will be analysed separate and combined, and the main hypothesis will be based on the latter.
- Health care utilization will be based on data from the Norwegian Patient Register. Data for in-patient and out-patients treatments for mental illness and other (separate analyses) will be used. These will be analysed separate and combined, and the main hypothesis will be based on the first.
The data will be analyzed in two rounds; first in 2019, and a follow-up analysis in 2022. A difference-in-difference approach will be used to measure the effects.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Naturalistic controlled trial with one municipality (Bodø) as treatment group and 10 similar municipalities without IPS services as controls.
| Arm | Type | Receives |
|---|---|---|
| Individual placement and support | Experimental | Behavioral: IPSGroup of patients receiving IPS to increase workforce participation. |
| Control | No intervention | –Group of patients receiving treatment as usual. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Severe mental illness
- Work assessment allowance
Key exclusion criteria (1 listed)
- Disability benefit
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 |
|---|---|---|
| IPSOccupational rehabilitation and support Integrated with clinical treatment | Behavioural | Individual placement and support |
Primary outcome
Long-term welfare dependency
Time frame: 15 years after implementation of IPS-services in Bodø (intervention municipality)
Rates of welfare dependency (rehabilitation benefits, disability benefits, sickness absence, unemployment benefits, and social benefits) in Bodø (intervention municipality) will be compared to rates of welfare dependency in 10 resembling municipalities (Kongsberg, Lier, Røyken, Horten, Tønsberg, Larvik, Færder, Porsgrunn, Grimstad og Steinkjer) without IPS-services (control municipalities) using Norwegian registry data.
6 secondary outcomes
Employment rate
Time frame: 3 years after implementation of IPS-services in Bodø, Norway
Employment rate
Time frame: 7 years after implementation of IPS-services in Bodø, Norway (intervention municipality)
Welfare dependency rate
Time frame: 3 years after implementation of IPS-services in Bodø (intervention municipality)
Welfare dependency rate
Time frame: 7 years after implementation of IPS-services in Bodø (intervention municipality)
Rates of treatments for mental illness
Time frame: 3 years after implementation of IPS-services in Bodø (intervention municipality)
Rates of treatments for mental illness
Time frame: 7 years after implementation of IPS-services in Bodø (intervention municipality)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Arnstein Mykletun, Prof PsyD principal investigator
Norwegian IPH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPS in people with Severe Mental Disorder, run by Norwegian Institute of Public Health 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 2 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 27 Nov 2019. 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?
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?
Long-term welfare dependency (time frame: 15 years after implementation of IPS-services in Bodø (intervention municipality)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2019.