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A Naturalistic Controlled Trial of Individual Placement and Control in Bodø

A Naturalistic Controlled Trial of Individual Placement and Control in Bodø

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04179877
Acronym
IPSBODO
Enrollment
77000
Registered
2019-11-27
Start date
2013-01-01
Completion date
2022-12-31
Last updated
2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Mental Disorder

Brief 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.

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.

Interventions

BEHAVIORALIPS

Occupational rehabilitation and support Integrated with clinical treatment

Sponsors

Nordlandssykehuset HF
CollaboratorOTHER
University of Tromso
CollaboratorOTHER
London School of Economics and Political Science
CollaboratorOTHER
University of Melbourne
CollaboratorOTHER
St George's Healthcare NHS Trust
CollaboratorOTHER
The University of New South Wales
CollaboratorOTHER
Norwegian Institute of Public Health
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

The control municipalities are unaware of this project, and are thus masked to the study.

Intervention model description

Naturalistic controlled trial with one municipality (Bodø) as treatment group and 10 similar municipalities without IPS services as controls.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Severe mental illness * Work assessment allowance

Exclusion criteria

* Disability benefit

Design outcomes

Primary

MeasureTime frameDescription
Long-term welfare dependency15 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.

Secondary

MeasureTime frameDescription
Rates of treatments for mental illness3 years after implementation of IPS-services in Bodø (intervention municipality)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.
Employment rate3 years after implementation of IPS-services in Bodø, NorwayRates 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).
Welfare dependency rate3 years after implementation of IPS-services in Bodø (intervention municipality)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).

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026