NCT04179877

A Naturalistic Controlled Trial of Individual Placement and Control in Bodø

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 77,000 (estimated)
• Sponsor: Norwegian Institute of Public Health · Other Government
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Mental Disorder

Interventions

Type	Name	Description
BEHAVIORAL	IPS	Occupational rehabilitation and support Integrated with clinical treatment

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-12-31
• Completion: 2022-12-31
• First posted: 2019-11-27
• Last updated: 2019-11-27

Locations

1 site across 1 country: Norway