NCT01964092

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 14, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

3.6 years

First QC Date

July 17, 2013

Results QC Date

September 28, 2019

Last Update Submit

May 4, 2020

Conditions

Keywords

DisabilityIndividual placement and supportMental healthQuality of lifeRandomized controlled trialRehabilitationReturn to workSupported employment

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Individual Placement and Support

EXPERIMENTAL

Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed.

Behavioral: Individual Placement and Support

Ordinary employment schemes

ACTIVE COMPARATOR

The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.

Behavioral: Ordinary employment schemes

Interventions

Individual Placement and Support
Ordinary employment schemes

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uni Research

Bergen, 5014, Norway

Location

Related Publications (3)

  • Sveinsdottir V, Lovvik C, Fyhn T, Monstad K, Ludvigsen K, Overland 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.

    PMID: 25403470BACKGROUND
  • Fyhn T, Ludvigsen K, Reme SE, Schaafsma F. A structured mixed method process evaluation of a randomized controlled trial of Individual Placement and Support (IPS). Implement Sci Commun. 2020 Oct 30;1:95. doi: 10.1186/s43058-020-00083-9. eCollection 2020.

  • Reme SE, Monstad K, Fyhn T, Sveinsdottir V, Lovvik C, Lie SA, Overland S. A randomized controlled multicenter trial of individual placement and support for patients with moderate-to-severe mental illness. Scand J Work Environ Health. 2019 Jan 1;45(1):33-41. doi: 10.5271/sjweh.3753. Epub 2018 Aug 2.

Related Links

MeSH Terms

Conditions

Psychotic DisordersSubstance-Related DisordersDepressionAnxiety DisordersPsychological Well-Being

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersChemically-Induced DisordersBehavioral SymptomsBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Silje Endresen Reme
Organization
University of Oslo

Study Officials

  • Silje E Reme, PhD

    NORCE Norwegian Research Centre AS

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

October 17, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

May 14, 2020

Results First Posted

May 14, 2020

Record last verified: 2020-05

Locations