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

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ClinicalTrials.gov Identifier: NCT01146730
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
Norwegian Labour and Welfare Administration
Information provided by (Responsible Party):
NORCE Norwegian Research Centre AS

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Workcoping and IPS Behavioral: Ordinary care by GP or NAV Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: At Work and Coping - Effect Evaluation of Center for Workcoping for Patients With Anxiety and Depression
Study Start Date : June 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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 Name: Treatment as usual


Outcome Measures
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Primary Outcome Measures :
  1. Sick leave data [ Time Frame: One year ]
    The primary outcome of the study is return to work measured through register data.


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146730


Locations
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Norway
Uni Reserach
Bergen, Norway, 5015
Sponsors and Collaborators
NORCE Norwegian Research Centre AS
Norwegian Labour and Welfare Administration
Investigators
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Principal Investigator: Silje E Reme, PhD NORCE Norwegian Research Centre AS
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NORCE Norwegian Research Centre AS
ClinicalTrials.gov Identifier: NCT01146730    
Other Study ID Numbers: Workcoping2010
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by NORCE Norwegian Research Centre AS:
Anxiety
Depression
Vocational Rehabilitation
 Common Mental Disorders
Mental Health Problems
Work Related Therapy
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
 Behavioral Symptoms
Mood Disorders
Mental Disorders