At Work and Coping - Effect Study of Workcoping for Patients With Anxiety and Depression (AWaC)
|ClinicalTrials.gov Identifier: NCT01146730|
Recruitment Status : Active, not recruiting
First Posted : June 17, 2010
Last Update Posted : February 23, 2017
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||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||At Work and Coping - Effect Evaluation of Center for Workcoping for Patients With Anxiety and Depression|
|Study Start Date :||June 2010|
|Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||August 2017|
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)
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
- Sick leave data [ Time Frame: One year ]The primary outcome of the study is return to work measured through register data.
- Psychopathology [ Time Frame: 6 and 12 months of follow up ]Secondary outcomes are reductions in psychopathology measured through validated questionnaires (e.g. HADS).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146730
|Bergen, Norway, 5015|
|Principal Investigator:||Silje E Reme, PhD||Uni Research|