Depression Clinical Trial
— AWaCOfficial title:
At Work and Coping - Effect Evaluation of Center for Workcoping for Patients With Anxiety and Depression
| NCT number | NCT01146730 |
| Other study ID # | Workcoping2010 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 2010 |
| Est. completion date | May 2018 |
| Verified date | July 2018 |
| Source | Uni Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1202 |
| Est. completion date | May 2018 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Uni Reserach | Bergen |
| Lead Sponsor | Collaborator |
|---|---|
| Uni Research | Norwegian Labour and Welfare Administration |
Norway,
Løvvik C, Øverland 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. — View Citation
Løvvik 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: 10.1 — View Citation
Olsen IB, Øverland S, Reme SE, Løvvik 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. — View Citation
Øverland 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. — View Citation
Reme SE, Grasdal AL, Løvvik C, Lie SA, Øverland 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(1 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sick leave data | The primary outcome of the study is return to work measured through register data. | One year | |
| Secondary | Psychopathology | Secondary outcomes are reductions in psychopathology measured through validated questionnaires (e.g. HADS). | 6 and 12 months of follow up |
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