Mental Health IssueCognitive SymptomPrimary Health Care
Investigational drug(s) / intervention(s)
Cognitive Testing
Cognitive Testing: Digital Cognitive Testing performed at home.
Study summary
The PrimeCog study aims to describe the symptomatology and pathophysiology of stress-induced exhaustion disorder (SED) and major depressive disorder (MDD) compared to healthy controls (HC). The participants will be recruited at primary care centers, and samples of blood, saliva, and hair will be collected. Digital questionnaires covering psychosocial variables and screening instruments for the detection of depression, anxiety, etc., along with a digital cognitive test battery, will be performed at home. Subsequently, an MRI of the brain will be performed, and analysis of biomarkers for stress, inflammation, and neurodegeneration will be conducted. These procedures will be repeated after twelve and twenty-four months. The study will investigate differences in the biomarkers, neuroimaging findings, and cognitive abilities between patients with SED, MDD, and controls over time. Associations between the symptom severity of MDD/SED and psychosocial variables, cognition, MRI, and the biomarkers will also be examined. The aim is to provide new diagnostic tools for differentiation between MDD and SED and guide individualized treatment based on underlying pathophysiology and cognitive function. All necessary competences for conducting this extensive study are represented within the research group. The PrimeCog study is unique in its comprehensive design, addressing knowledge gaps, and directly comparing these diagnoses over time in primary care, where patients are typically treated.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. adults 18 to 65 years old;
2. fluent in Swedish;
3. corrected to normal vision and hearing;
4. (for cases), newly diagnosed with MDD or SED (i.e., received as new diagnosis at the visit to the physician) according to the diagnostic criteria from DSM-V (MDD) and the Swedish Board of Health and Welfare (SED)
Exclusion Criteria:
1. already ongoing treatment for MDD/SED or previous diagnosis of MDD/SED within the last year;
2. history of serious mental illness (defined as mental illness that has required psychiatric in-patient care);
3. acute cerebrovascular event or severe head trauma in the last 6 months;
4. known cognitive impairment;
5. substance dependence, ongoing or past;
6. motor disability or impairment affecting interaction with the digital tests;
7. photosensitive epilepsy or -migraines.
For the MRI subgroup, any contraindication to MRI is an exclusion criterion.
Primary outcome measure(s)
Cognitive Test Results regarding attention and processing speed — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding attention and processing speed measured by TMT-A vary between individuals with MDD/SED and HC?
Cognitive Test Results regarding attention and processing speed — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding attention and processing speed measured by TMT-B vary between individuals with MDD/SED and HC?
Cognitive Test Results regarding attention and processing speed — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding attention and processing speed measured by SDPTvary between individuals with MDD/SED and HC?
Cognitive Test Results regarding attention and processing speed — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding attention and processing speed measured by Reaction Time Test Simple vary between individuals with MDD/SED and HC?
Cognitive Test Results regarding memory — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding memory, measured by Corsi Span forward and backward, vary between individuals with MDD/SED and HC?
Cognitive Test Results regarding memory — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding memory, measured by RAVLT Learning and Recall vary between individuals with MDD/SED and HC?
Cognitive Test Results regarding executive function — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding executive functions, measured by TMT-B, vary between individuals with MDD/SED and HC?
Cognitive Test Results regarding executive function — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding executive functions, measured by Reaction Time Test Complex (or CPT) vary between individuals with MDD/SED and HC?
Cognitive Test Results regarding executive function — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding executive functions, measured by Stroop Test vary between individuals with MDD/SED and HC?
Cognitive Test Results regarding language — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding language, measured by FAS vary between individuals with MDD/SED and HC?
Cognitive Test Results regarding language — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding language, measured by Boston Naming Test vary between individuals with MDD/SED and HC?
Cognitive Test Results regarding visuospatial capacity — At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline) How do cognitive test results regarding visuospatial capacity measured by: Cube Copying Test, vary between individuals with MDD/SED and HC?
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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