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Recruiting NCT07349550

AtWork: The Relation Between Cognitive Functioning, Common Mental Disorders and Work Functioning

Observational Depression - Major Depressive Disorder Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder, Anxiety. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Norway · 1 center
  • Diakonhjemmet hospital — Oslo

Identifiers

NCT: NCT07349550 · AtWork

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗