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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01964092
Other study ID # IPS-NAV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2013
Est. completion date December 2018

Study information

Verified date May 2020
Source NORCE Norwegian Research Centre AS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Roughly one third of disability pensions issued in Norway are classified as mental and behavioral disorders. The proposed study aims to evaluate the effect of an innovative intervention for returning people with moderate to severe mental health disorders to work: Individual Placement and Support (IPS).


Description:

The current employment schemes offered to this diagnostic group are primarily based on a train-and-place principle with assisted or sheltered employment. Building on a place-and-train principle, rather, the IPS model of supported employment in real-life competitive work settings has proven largely successful in previous studies, but has never been tested in this group in the Norwegian context.


Recruitment information / eligibility

Status Completed
Enrollment 410
Est. completion date December 2018
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 67 Years
Eligibility Inclusion Criteria:

- Participants must be undergoing treatment for moderate to severe mental health problems.

- Participants must have an expressed desire to work.

- Participants must have sufficient Norwegian reading and writing skills.

Exclusion Criteria:

- Participants are not undergoing treatment for moderate to severe mental health problems.

- Participants do not have an expressed desire to work.

- Participants do not have sufficient Norwegian reading and writing skills.

Study Design


Intervention

Behavioral:
Individual Placement and Support

Ordinary employment schemes


Locations

Country Name City State
Norway Uni Research Bergen

Sponsors (2)

Lead Sponsor Collaborator
NORCE Norwegian Research Centre AS Norwegian Labour and Welfare Administration

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Sveinsdottir V, Løvvik C, Fyhn T, Monstad K, Ludvigsen K, Øverland S, Reme SE. Protocol for the effect evaluation of Individual Placement and Support (IPS): a randomized controlled multicenter trial of IPS versus treatment as usual for patients with moderate to severe mental illness in Norway. BMC Psychiatry. 2014 Nov 18;14:307. doi: 10.1186/s12888-014-0307-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Labor Market Participation in Ordinary Paid Employment, or Education. Labor market participation is operationalized as being registered in the Norwegian Labour and Welfare Administrations (NAV) State Register of Employers and Employees, and not as a recipient of unemployment or sickness benefits, not receiving work assessment allowance or disability pension with a higher degree of disability than by study inclusion, and registered yearly income. 1 year (2016)
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