Text Size

Effect Study of Workcoping for Patients With Anxiety and Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Norwegian Labour and Welfare Administration
Information provided by (Responsible Party):
Stein Atle Lie, Uni Research
ClinicalTrials.gov Identifier:
NCT01146730
First received: June 1, 2010
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Anxiety
Depression
 Behavioral: Workcoping and IPS
Behavioral: Ordinary care by GP or NAV
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect Evaluation of Center for Workcoping for Patients With Anxiety and Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uni Research:

Primary Outcome Measures:
  • Sick leave data [ Time Frame: One year ] [ Designated as safety issue: No ]
    The primary outcome of the study is return to work measured through register data.


Secondary Outcome Measures:
  • Psychopathology [ Time Frame: 6 and 12 months of follow up ] [ Designated as safety issue: No ]
    Secondary outcomes are reductions in psychopathology measured through validated questionnaires (e.g. HADS).


Enrollment: 1202
Study Start Date: June 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146730

Locations
Norway
Uni Reserach
Bergen, Norway, 5015
Sponsors and Collaborators
Uni Research
The Norwegian Labour and Welfare Administration
Investigators
Principal Investigator: Stein Atle Lie, PhD Uni Research
  More Information

Additional Information:
Project description  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Stein Atle Lie, Professor Stein Atle Lie, Uni Research
ClinicalTrials.gov Identifier: NCT01146730     History of Changes
Other Study ID Numbers: Workcoping2010
Study First Received: June 1, 2010
Last Updated: October 15, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Uni Research:
Anxiety
Depression
Vocational Rehabilitation
 Common Mental Disorders
Mental Health Problems
Work Related Therapy

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
 Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 21, 2013