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

July 9, 2018 updated by: NORCE Norwegian Research Centre AS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5015
        • Uni Reserach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Workcoping and IPS
CBT based counseling and supported employment
Behavioral: Workcoping 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)
Other Names:
  • Cognitive behavior therapy
  • Cognitive Counseling
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
Ordinary care by the participants physician or the local Labour and Welfare Administration
Other Names:
  • Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sick leave data
Time Frame: One year
The primary outcome of the study is return to work measured through register data.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychopathology
Time Frame: 6 and 12 months of follow up
Secondary outcomes are reductions in psychopathology measured through validated questionnaires (e.g. HADS).
6 and 12 months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NORCE Norwegian Research Centre AS

Collaborators

Norwegian Labour and Welfare Administration

Investigators

  • Principal Investigator: Silje E Reme, PhD, NORCE Norwegian Research Centre AS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

June 1, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Workcoping2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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