AnxietyAWaCNCT01146730
At Work and Coping - Effect Study of Workcoping for Patients With Anxiety and Depression
A study testing Workcoping and IPS and Ordinary care by GP or NAV in people with Anxiety and Depression, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Workcoping and IPS and Ordinary care by GP or NAV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,202 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2010to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Problems coping with work due to psychological illness (anxiety and depression)
- Reasonable closeness to work (possible to return within a year)
Who cannot join
- Other reasons as primary cause of work problems
- Serous psychiatric disorders
- Suicide risk
- Pregnancy
- Ongoing psychological treatment (therapy)
- Ongoing substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: At Work and Coping - Effect Evaluation of Center for Workcoping for Patients With Anxiety and Depression
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.
- Conditions
- Anxiety, Depression
- Being tested
- Workcoping and IPS, Ordinary care by GP or NAV
- Keywords
- Anxiety, Depression, Vocational Rehabilitation, Common Mental Disorders, Mental Health Problems, Work Related Therapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workcoping and IPSBehavioural
Also called Cognitive behavior therapy, Cognitive Counseling
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)
Ordinary care by GP or NAVBehavioural
Also called Treatment as usual
Ordinary care by the participants physician or the local Labour and Welfare Administration
| Study group | Role | What they receive |
|---|---|---|
| Workcoping and IPS | Experimental | CBT based counseling and supported employment Receives: Behavioral: Workcoping and IPS |
| Ordinary care by GP or NAV | Active comparator | Ordinary care by GP or The Norwegian Labour and Welfare Administration (NAV) Receives: Behavioral: Ordinary care by GP or NAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sick leave data
The primary outcome of the study is return to work measured through register data.
Measured: One year
Secondary outcomes (1)
Psychopathology
Secondary outcomes are reductions in psychopathology measured through validated questionnaires (e.g. HADS).
Measured: 6 and 12 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,202 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Responsible party
- Sponsor
- Investigators
- Silje E Reme, PhD, Principal investigator, NORCE Norwegian Research Centre AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146730
- Sponsor's protocol ID
- Workcoping2010
- Acronym
- AWaC
- Status last verified
- Jul 2018
- First submitted
- 1 Jun 2010
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23595310Lovvik 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.
PubMed 24589824Reme 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.
PubMed 26251065Overland 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.
PubMed 29736442Olsen 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.
PubMed 25451074Overland 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.
PubMed 30032103
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At Work and Coping - Effect Evaluation of Center for Workcoping for Patients With Anxiety and Depression
- ClinicalTrials.gov ID
- NCT01146730
- Acronym / sponsor ID
- AWaC / Workcoping2010
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety, Depression, Vocational Rehabilitation, Common Mental Disorders, Mental Health Problems, Work Related Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,202 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Study start
- Jun 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workcoping and IPS | Experimental | Behavioral: Workcoping and IPSCBT based counseling and supported employment |
| Ordinary care by GP or NAV | Active comparator | Behavioral: Ordinary care by GP or NAVOrdinary care by GP or The Norwegian Labour and Welfare Administration (NAV) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Problems coping with work due to psychological illness (anxiety and depression)
- Reasonable closeness to work (possible to return within a year)
Key exclusion criteria (6 listed)
- Other reasons as primary cause of work problems
- Serous psychiatric disorders
- Suicide risk
- Pregnancy
- Ongoing psychological treatment (therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workcoping and IPSAlso: Cognitive behavior therapy, Cognitive CounselingMaximum 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) | Behavioural | Workcoping and IPS |
| Ordinary care by GP or NAVAlso: Treatment as usualOrdinary care by the participants physician or the local Labour and Welfare Administration | Behavioural | Ordinary care by GP or NAV |
Primary outcome
Sick leave data
Time frame: One year
The primary outcome of the study is return to work measured through register data.
1 secondary outcome
Psychopathology
Time frame: 6 and 12 months of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Results publication: PubMed 23595310Lovvik 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 publication: PubMed 24589824Lovvik 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 publication: PubMed 26251065Reme 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 publication: PubMed 29736442Overland 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 publication: PubMed 25451074Olsen 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.
- Derived from this study: PubMed 30032103Overland 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Recruiting
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
Generalized Anxiety Disorder
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silje E Reme, PhD principal investigator
NORCE Norwegian Research Centre AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workcoping and IPS and Ordinary care by GP or NAV in people with Anxiety and Depression, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sick leave data (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01146730, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.