CClinicalTrials.gg
CompletedNCT01146730AWaCUpdated Jul 11, 2018

At Work and Coping - Effect Study of Workcoping for Patients With Anxiety and Depression

An interventional study of Workcoping and IPS and Ordinary care by GP or NAV in Anxiety and Depression, sponsored by NORCE Norwegian Research Centre AS. Completed at 1 site in Norway. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-11.

Sponsored by NORCE Norwegian Research Centre AS · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,202
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety
  • Depression

Keywords

  • Anxiety
  • Depression
  • Vocational Rehabilitation
  • Common Mental Disorders
  • Mental Health Problems
  • Work Related Therapy
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 1,202 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

NORCE Norwegian Research Centre AS is the lead sponsor of 23 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Other reasons as primary cause of work problems
  • Serous psychiatric disorders
  • Suicide risk
  • Pregnancy
  • Ongoing psychological treatment (therapy)
  • Ongoing substance abuse
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,202 participants (actual)

Study arms

  • Experimental
    Workcoping and IPS

    CBT based counseling and supported employment

    Behavioral: Workcoping and IPS

  • Active comparator
    Ordinary care by GP or NAV

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

    Behavioral: Ordinary care by GP or NAV

Interventions

  • BehavioralWorkcoping and IPS

    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

  • BehavioralOrdinary care by GP or NAV

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

    Also known as: Treatment as usual

06

What researchers measure

Primary outcomes

  1. Sick leave data

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

    Time frame: One year

Secondary outcomes

  1. Psychopathology

    Secondary outcomes are reductions in psychopathology measured through validated questionnaires (e.g. HADS).

    Time frame: 6 and 12 months of follow up

07

Study locations

1 site
  • Uni Reserach
    Bergen, 5015, Norway
08

References and documents

Publications

  • 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. PubMed 23595310 ↗
  • 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. PubMed 24589824 ↗
  • 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. PubMed 26251065 ↗
  • 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. PubMed 29736442 ↗
  • 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. PubMed 25451074 ↗
  • 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. PubMed 30032103 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01146730
Lead sponsor
NORCE Norwegian Research Centre AS
Collaborators
Norwegian Labour and Welfare Administration
Responsible party
Sponsor
First posted
Jun 17, 2010
Start date
Jun 2010
Primary completion
Mar 2016
Completion
May 2018
Last update
Jul 11, 2018

Study contacts

Silje E Reme, PhD
principal investigator · NORCE Norwegian Research Centre AS

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion