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

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Workcoping and IPS
Ordinary care by GP or NAV
Sponsored by
NORCE Norwegian Research Centre AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Depression, Vocational Rehabilitation, Common Mental Disorders, Mental Health Problems, Work Related Therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Uni Reserach

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Workcoping and IPS

Ordinary care by GP or NAV

Arm Description

CBT based counseling and supported employment

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2010
Last Updated
July 9, 2018
Sponsor
NORCE Norwegian Research Centre AS
Collaborators
Norwegian Labour and Welfare Administration
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1. Study Identification

Unique Protocol Identification Number
NCT01146730
Brief Title
At Work and Coping - Effect Study of Workcoping for Patients With Anxiety and Depression
Acronym
AWaC
Official Title
At Work and Coping - Effect Evaluation of Center for Workcoping for Patients With Anxiety and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS
Collaborators
Norwegian Labour and Welfare Administration

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
Anxiety, Depression, Vocational Rehabilitation, Common Mental Disorders, Mental Health Problems, Work Related Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Workcoping and IPS
Arm Type
Experimental
Arm Description
CBT based counseling and supported employment
Arm Title
Ordinary care by GP or NAV
Arm Type
Active Comparator
Arm Description
Ordinary care by GP or The Norwegian Labour and Welfare Administration (NAV)
Intervention Type
Behavioral
Intervention Name(s)
Workcoping and IPS
Other Intervention Name(s)
Cognitive behavior therapy, Cognitive Counseling
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Ordinary care by GP or NAV
Other Intervention Name(s)
Treatment as usual
Intervention Description
Ordinary care by the participants physician or the local Labour and Welfare Administration
Primary Outcome Measure Information:
Title
Sick leave data
Description
The primary outcome of the study is return to work measured through register data.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Psychopathology
Description
Secondary outcomes are reductions in psychopathology measured through validated questionnaires (e.g. HADS).
Time Frame
6 and 12 months of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silje E Reme, PhD
Organizational Affiliation
NORCE Norwegian Research Centre AS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uni Reserach
City
Bergen
ZIP/Postal Code
5015
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23595310
Citation
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.
Results Reference
result
PubMed Identifier
24589824
Citation
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.
Results Reference
result
PubMed Identifier
26251065
Citation
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.
Results Reference
result
PubMed Identifier
29736442
Citation
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.
Results Reference
result
PubMed Identifier
25451074
Citation
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.
Results Reference
result
PubMed Identifier
30032103
Citation
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.
Results Reference
derived
Links:
URL
http://uni.no/nb/uni-helse/stress-helse-og-rehabilitering/effektevaluering-av-senter-for-jobbmestring/
Description
Study website

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

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