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Status unknownNCT04179877IPSBODOUpdated Nov 27, 2019

A Naturalistic Controlled Trial of Individual Placement and Control in Bodø

An interventional study of IPS in Severe Mental Disorder, sponsored by Norwegian Institute of Public Health. Status unknown at 1 site in Norway. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-11-27.

Sponsored by Norwegian Institute of Public Health · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 5 years 10 months after the study started (first participant enrolled Jan 2013, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
77,000
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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

  1. increasing employment,
  2. reducing welfare dependency, and
  3. 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:

  1. Employment will be based on registry data from tax records with information both on employment (yes/no and period) and taxable income (NOK).
  2. 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.
  3. 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.

02

Conditions studied

  • Severe Mental Disorder

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03

In context

Mental Disorders

2,148 studies on the registry are indexed under Mental Disorders; 425 are open to participants now.

This study's planned enrollment of 77,000 is above the median of 96 across 1,607 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Norwegian Institute of Public Health is the lead sponsor of 51 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Severe mental illness
  • Work assessment allowance

Exclusion criteria

Exclusion Criteria:

  • Disability benefit
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
77,000 participants (estimated)

Study arms

  • Experimental
    Individual placement and support

    Group of patients receiving IPS to increase workforce participation.

    Behavioral: IPS

  • No intervention
    Control

    Group of patients receiving treatment as usual.

Interventions

  • BehavioralIPS

    Occupational rehabilitation and support Integrated with clinical treatment

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 years after implementation of IPS-services in Bodø (intervention municipality)

Secondary outcomes

  1. 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).

    Time frame: 3 years after implementation of IPS-services in Bodø, Norway

  2. 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).

    Time frame: 7 years after implementation of IPS-services in Bodø, Norway (intervention municipality)

  3. 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).

    Time frame: 3 years after implementation of IPS-services in Bodø (intervention municipality)

  4. 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.

    Time frame: 7 years after implementation of IPS-services in Bodø (intervention municipality)

  5. 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.

    Time frame: 3 years after implementation of IPS-services in Bodø (intervention municipality)

  6. 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.

    Time frame: 7 years after implementation of IPS-services in Bodø (intervention municipality)

07

Study locations

1 site
  • Nordland Hospital Trust
    Bodø, Nordland 8092, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04179877
Lead sponsor
Norwegian Institute of Public Health
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
First posted
Nov 27, 2019
Start date
Jan 1, 2013
Primary completion
Dec 31, 2016
Completion
Dec 31, 2022 (estimated)
Last update
Nov 27, 2019

Study contacts

Arnstein Mykletun, Prof PsyD
principal investigator · Norwegian IPH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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