- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07349550
AtWork: The Relation Between Cognitive Functioning, Common Mental Disorders and Work Functioning (AtWork)
Study Overview
Status
Conditions
Detailed Description
The study is a naturalistic study exploring cognitive functioning of patients with common mental disorders (CMD) treated with metacognitive therapy and work focused interventions, and changes over time.
Sick leave is common for patients with CMD, also after having completed treatment for CMD. Why patients remain on sick leave after having completed treatment is underexplored. Potential reasons may be that work and sick leave is not addressed during therapy, there could be issues related to the work place, also there may be characteristics related to the patients functioning that is underexplored. In the latter context, little knowledge regarding the relations between cognitive functioning, symptoms of CMD and work functioning. Previous studies have investigated neuropsychological functions in relation to work related stress and stress-related exhaustion, and found worse performance on cognitive tasks compared to healthy controls. Although stress-related exhaustion can be considered a phenomenon related to CMD, there are no studies the investigators are aware of that investigate neuropsychological predictors specifically related to CMD and work functioning. A review from 2022 specifically aimed to identify neuropsychological predictors of vocational rehabilitation outcomes in individuals with MDD specifically, and found no studies. This clearly demonstrates a knowledge gap that this project would fill. E.g., lower cognitive functioning after successful treatment of CMD is related to increased risk of additional sick leave. With this in mind, increasing our knowledge of these variables can help clinicians identify patients at risk for additional sick leave, even after successful treatment. A previous study at the same clinic has identified three subgroups in a sample of patients with CMD at risk of sick leave. The first group was never on sick leave. The second group returned to work after sick leave during or shortly after treatment. In the third group half of the patients remained on sick leave or disability. To better understand characteristics of such subgroups it is relevant to explore standard clinical information given in the patient's journal. This project is mainly, but not exclusively a PhD-project. The time schedule for the project will go beyond the time for the PhD, especially long-time follow-up.
The main aims of the project are the following:
To explore how descriptive variables, CMD symptoms, and cognitive functioning are associated with work functioning (sick leave or risk for sick leave) before treatment. And what is the interplay between symptoms, cognitive profiles and sick leave.
To explore whether cognitive functioning can predict outcomes of both symptoms of CMD and degree of sick leave, and if cognitive functioning changes through MCT and work focused interventions.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Odin Hjemdal, PhD
- Phone Number: +4773597889
- Email: odin.hjemdal@ntnu.no
Study Locations
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Oslo, Norway
- Recruiting
- Diakonhjemmet Hospital
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Contact:
- Odin Hjemdal, PhD
- Phone Number: +4773597889
- Email: odin.hjemdal@ntnu.no
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- diagnosis of depression and/or anxiety,
- at risk of sick leave
Exclusion Criteria:
- personality disorders cluster A or B,
- ongoing substance abuse,
- symptoms of psychosis,
- acute suicidality,
- serious somatic disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients referred with depression and/or anxiety and at risk of sick leave
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up
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Measure of depressive symptoms (PHQ-9) range 0-27 higher scores indicate higher degree of depressive symptoms
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Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up
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Generalized Anxiety Disorder (GAD-7)
Time Frame: Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up
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Anxiety symptoms (GAD-7) range 0-21 higher scores indicating higher degree of anxiety symptoms
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Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up
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Changes in sick leave
Time Frame: Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up
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Sick leave is collected from national register data measured in number of days of sick leave.
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Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AtWork
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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