Depression - Major Depressive DisorderAtWorkNCT07349550
AtWork: The Relation Between Cognitive Functioning, Common Mental Disorders and Work Functioning
An observational study of Depression - Major Depressive Disorder and Anxiety, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Depression and anxiety affects levels of function across different levels like work, increasing levels of sick leave and as well as cognitive functioning. In the current study patients at risk of sick leave with depression and anxiety receive metacognitive therapy and work focus in an ordinary outpatient clinic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Anxiety
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2024to 1 Aug 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred with depression and/or anxiety disorders at risk of sick leave.
Who may be able to join
- diagnosis of depression and/or anxiety,
- at risk of sick leave
Who cannot join
- personality disorders cluster A or B,
- ongoing substance abuse,
- symptoms of psychosis,
- acute suicidality,
- serious somatic disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Diakonhjemmet hospital
Oslo
Odin Hjemdal, PhD, +4773597889, odin.hjemdal@ntnu.no
About this study
Depression and anxiety affects levels of function across different levels like work, increasing levels of sick leave and as well as cognitive functioning. In the current study patients at risk of sick leave with depression and anxiety receive metacognitive therapy and work focus in an ordinary outpatient clinic. Impaired cognitive functioning may also be of importance in the return to work process and degree of sick leave. It is important to get a better understanding of how cognitive functioning is related to sick leave and if it predicts return to work, and if cognitive functioning is changed due to psychological treatment.
Read the 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.
- Conditions
- Depression - Major Depressive Disorder, Anxiety
- Keywords
- Metacognitive therapy, Work focus, Depression, Anxiety, Sick leave
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients referred with depression and/or anxiety and at risk of sick leave | Patients referred with depression and/or anxiety and at risk of sick leave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Measure of depressive symptoms (PHQ-9) range 0-27 higher scores indicate higher degree of depressive symptoms
Measured: Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up
Generalized Anxiety Disorder (GAD-7)
Anxiety symptoms (GAD-7) range 0-21 higher scores indicating higher degree of anxiety symptoms
Measured: Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up
Changes in sick leave
Sick leave is collected from national register data measured in number of days of sick leave.
Measured: Measured at pre-treatment and at therapy completion, an average of 10 weekly sessions, and at 6, 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2024
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Diakonhjemmet Hospital, The Research Council of Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349550
- Sponsor's protocol ID
- AtWork
- Acronym
- AtWork
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical considerations as this is a clinical study that includes patients with depression and/or anxiety at risk of sick leave, information will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AtWork: The Relation Between Cognitive Functioning, Common Mental Disorders and Work Functioning
- ClinicalTrials.gov ID
- NCT07349550
- Acronym / sponsor ID
- AtWork / AtWork
- Conditions
- Depression - Major Depressive Disorder, Anxiety
- Keywords
- Metacognitive therapy, Work focus, Depression, Anxiety, Sick leave
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Diakonhjemmet Hospital, The Research Council of Norway
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2032 (estimated)
- First posted
- 20 Jan 2026 (actual)
- 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.
Depression and anxiety affects levels of function across different levels like work, increasing levels of sick leave and as well as cognitive functioning. In the current study patients at risk of sick leave with depression and anxiety receive metacognitive therapy and work focus in an ordinary outpatient clinic. Impaired cognitive functioning may also be of importance in the return to work process and degree of sick leave. It is important to get a better understanding of how cognitive functioning is related to sick leave and if it predicts return to work, and if cognitive functioning is changed due to psychological treatment.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred with depression and/or anxiety and at risk of sick leave | – | –Patients referred with depression and/or anxiety and at risk of sick leave |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred with depression and/or anxiety disorders at risk of sick leave.
Key inclusion criteria (2 listed)
- diagnosis of depression and/or anxiety,
- at risk of sick leave
Key exclusion criteria (5 listed)
- personality disorders cluster A or B,
- ongoing substance abuse,
- symptoms of psychosis,
- acute suicidality,
- serious somatic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Measure of depressive symptoms (PHQ-9) range 0-27 higher scores indicate higher degree of depressive symptoms
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
Anxiety symptoms (GAD-7) range 0-21 higher scores indicating higher degree of anxiety symptoms
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
Sick leave is collected from national register data measured in number of days of sick leave.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. Due to ethical considerations as this is a clinical study that includes patients with depression and/or anxiety at risk of sick leave, information will not be shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder and Anxiety, run by Norwegian University of Science and Technology 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 5 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Odin Hjemdal, PhD (+4773597889, odin.hjemdal@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.