A Naturalistic Controlled Trial of Individual Placement and Control in Bodø

NCT04179877 | Unknown

• 1 other identifier: IPSBODO
• Study Type: interventional
• Target: 77,000
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to test the effectiveness of Individual Placement and Support (IPS) on

1. 1.employment,
2. 2.welfare dependency, and
3. 3.public-sector health care utilization.

Conditions

Severe Mental Disorder

Outcome Measures

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.

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

Secondary Outcomes (6)

• Employment rate

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

• Employment rate

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

• Welfare dependency rate

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

• Welfare dependency rate

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

• Rates of treatments for mental illness

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

Study Arms (2)

Individual placement and support

EXPERIMENTAL

Group of patients receiving IPS to increase workforce participation.

Behavioral: IPS

Control

NO INTERVENTION

Group of patients receiving treatment as usual.

Interventions

IPS BEHAVIORAL

Occupational rehabilitation and support Integrated with clinical treatment

Individual placement and support

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Severe mental illness
• Work assessment allowance

You may not qualify if:

• Disability benefit

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• Nordlandssykehuset HF: collaborator
• University of Tromso: collaborator
• London School of Economics and Political Science: collaborator
• University of Melbourne: collaborator
• St George's Healthcare NHS Trust: collaborator
• The University of New South Wales: collaborator

Study Sites (1)

Nordland Hospital Trust

Bodø, Nordland, 8092, Norway

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Arnstein Mykletun, Prof PsyD

  Norwegian IPH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The control municipalities are unaware of this project, and are thus masked to the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: November 27, 2019
• Study Start: January 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2022
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)