NCT01146730

Brief Summary

Mental disorders, mainly various anxiety and depressive disorders, are an increasing reason for sick leave and disability pension. Cognitive behaviour therapy (CBT) has been shown to have an effect on anxiety and depression, but the investigators know little about this in relation to employment. Close follow-up in ordinary employment increase employment participation for serious mental illness, but this is not yet investigated to the same degree for lighter mental disorders. Center for Work-Coping (No: "Senter for Jobbmestring" - SJM) combines Cognitive behaviour therapy (CBT) and individual placement and support (IPS) and facilitation of work for people with anxiety and depression who are in danger of falling out of work. The purpose of this project is to evaluate the effectiveness of the model in SJM. The effect will be evaluated through a randomized controlled trial (RCT) in which participants will be randomized to SJM or regular follow-up by The Norwegian Labour and Welfare Administration (NAV) or by their regular general practitioners (GP) and self-help resources. The main outcome measures are work participation with changes in mental health as a secondary outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,202

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable anxiety

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

First Submitted

Initial submission to the registry

June 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

5.8 years

First QC Date

June 1, 2010

Last Update Submit

July 9, 2018

Conditions

Keywords

AnxietyDepressionVocational RehabilitationCommon Mental DisordersMental Health ProblemsWork Related Therapy

Outcome Measures

Primary Outcomes (1)

  • Sick leave data

    The primary outcome of the study is return to work measured through register data.

    One year

Secondary Outcomes (1)

  • Psychopathology

    6 and 12 months of follow up

Study Arms (2)

Workcoping and IPS

EXPERIMENTAL

CBT based counseling and supported employment

Behavioral: Workcoping and IPS

Ordinary care by GP or NAV

ACTIVE COMPARATOR

Ordinary care by GP or The Norwegian Labour and Welfare Administration (NAV)

Behavioral: Ordinary care by GP or NAV

Interventions

Maximum 15 sessions of CBT-based counseling with workcoping as primary focus in addition to work support according to the IPS-model (individual placement and support)

Also known as: Cognitive behavior therapy, Cognitive Counseling
Workcoping and IPS

Ordinary care by the participants physician or the local Labour and Welfare Administration

Also known as: Treatment as usual
Ordinary care by GP or NAV

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Problems coping with work due to psychological illness (anxiety and depression)
  • Reasonable closeness to work (possible to return within a year)

You may not qualify if:

  • Other reasons as primary cause of work problems
  • Serous psychiatric disorders
  • Suicide risk
  • Pregnancy
  • Ongoing psychological treatment (therapy)
  • Ongoing substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uni Reserach

Bergen, 5015, Norway

Location

Related Publications (6)

  • Lovvik C, Overland S, Hysing M, Broadbent E, Reme SE. Association between illness perceptions and return-to-work expectations in workers with common mental health symptoms. J Occup Rehabil. 2014 Mar;24(1):160-70. doi: 10.1007/s10926-013-9439-8.

  • Lovvik C, Shaw W, Overland S, Reme SE. Expectations and illness perceptions as predictors of benefit recipiency among workers with common mental disorders: secondary analysis from a randomised controlled trial. BMJ Open. 2014 Mar 3;4(3):e004321. doi: 10.1136/bmjopen-2013-004321.

  • Reme SE, Grasdal AL, Lovvik C, Lie SA, Overland S. Work-focused cognitive-behavioural therapy and individual job support to increase work participation in common mental disorders: a randomised controlled multicentre trial. Occup Environ Med. 2015 Oct;72(10):745-52. doi: 10.1136/oemed-2014-102700. Epub 2015 Aug 6.

  • Overland S, Grasdal A, Reme SE. Trial participant representativeness compared to ordinary service users in a work rehabilitation setting. Contemp Clin Trials Commun. 2015 Dec 17;2:12-15. doi: 10.1016/j.conctc.2015.12.005. eCollection 2016 Apr 15.

  • Olsen IB, Overland S, Reme SE, Lovvik C. Exploring Work-Related Causal Attributions of Common Mental Disorders. J Occup Rehabil. 2015 Sep;25(3):493-505. doi: 10.1007/s10926-014-9556-z.

  • Overland S, Grasdal AL, Reme SE. Long-term effects on income and sickness benefits after work-focused cognitive-behavioural therapy and individual job support: a pragmatic, multicentre, randomised controlled trial. Occup Environ Med. 2018 Oct;75(10):703-708. doi: 10.1136/oemed-2018-105137. Epub 2018 Jul 21.

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Myo-Inositol-1-Phosphate SynthaseCognitive Behavioral TherapyTherapeutics

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Intramolecular LyasesIsomerasesEnzymesEnzymes and CoenzymesBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Silje E Reme, PhD

    NORCE Norwegian Research Centre AS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 17, 2010

Study Start

June 1, 2010

Primary Completion

March 1, 2016

Study Completion

May 1, 2018

Last Updated

July 11, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations