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| Name | Class |
|---|---|
| Örebro University, Sweden | OTHER |
| Uppsala University | OTHER |
| Karolinska Institutet | OTHER |
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In a 12 week randomly controlled open trial 102 participants with symptoms of depression and/or anxiety will be exposed to either aerobic high intensity training (HIT) or relaxation therapy. Cognitive functions, biomarkers, psychiatric symptom scales and physical status will be collected at baseline, after 12 weeks and after a year. Depression and anxiety will be measured twice during the intervention period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Exercise Group | Active Comparator | 45 minutes of aerobic, high intensity group training, three times per week during a 12-week period. |
|
| Relaxation Group | Other | 45 minutes of relaxation therapy once per week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Exercise | Other | Physical exercise as described before. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom improvement in depression | Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale (MADRS). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome. | Change of the score from the baseline to the score at 12 weeks. |
| Symptom improvement in depression | Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale (MADRS). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome. | Change of the score from the baseline to the score at 1 year. |
| Symptom improvement in anxiety | Improvement of symptom severity grade are assessed with Beck Anxiety Inventory (BAI). The minimum and the maximum score is 0 and 63 respectively, and the higher score means a worse outcome. | Change of the score from the baseline to the score at 12 weeks. |
| Symptom improvement in anxiety | Improvement of symptom severity grade are assessed with Beck Anxiety Inventory (BAI). The minimum and the maximum score is 0 and 63 respectively, and the higher score means a worse outcome. | Change of the score from the baseline to the score at 1 year. |
| Subjective symptom improvement in depression | Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale Self-Rating Version (MADRS-S). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome. | Change of the score from the baseline to the score at 12 weeks. |
| Subjective symptom improvement in depression |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function: Trail Making Test Part A&B | Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. | Comparison of results between baseline and week 12. |
| Cognitive function: Trail Making Test Part A&B |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gut microbiomes | The fecal samples will be analyzed for microbial composition using 16S microbiome analysis, metabolomics and Next Generation Sequencing. | Up to 1 year from baseline. |
| Investigation of inflammatory biomarkers profile |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Freund-Levi, MD, PhD | Region Örebro County/Örebro University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, University hospital Örebro | Örebro | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31681117 | Background | Bjorngrim S, van den Hurk W, Betancort M, Machado A, Lindau M. Comparing Traditional and Digitized Cognitive Tests Used in Standard Clinical Evaluation - A Study of the Digital Application Minnemera. Front Psychol. 2019 Oct 18;10:2327. doi: 10.3389/fpsyg.2019.02327. eCollection 2019. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D009043 | Motor Activity |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Relaxation Therapy |
| Other |
Relaxation therapy as described before. |
|
Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale Self-Rating Version (MADRS-S). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome. |
| Change of the score from the baseline to the score at 1 year. |
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. |
| Comparison of results between baseline and year 1. |
| Cognitive function: Symbol Digit Modalities Test | Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. | Comparison of results between baseline and week 12. |
| Cognitive function: Symbol Digit Modalities Test | Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. | Comparison of results between baseline and year 1. |
| Cognitive function: Corsi Block-Tapping Test forward | Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. | Comparison of results between baseline and week 12. |
| Cognitive function: Corsi Block-Tapping Test forward | Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. | Comparison of results between baseline and year 1. |
| Cognitive function: Rey Auditory Verbal Learning Test | Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. | Comparison of results between baseline and week 12. |
| Cognitive function: Rey Auditory Verbal Learning Test | Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. | Comparison of results between baseline and year 1. |
| Cognitive function: Stroop test | Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. | Comparison of results between baseline and week 12. |
| Cognitive function: Stroop test | Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. | Comparison of results between baseline and year 1. |
| Clinical Global Impression (CGI) severity scale | Clinician's impression of total severity of the mental illness. Scale between 0 and 7, higher point indicates worse outcome. | Up to 1 year from baseline. |
| Posttraumatic Stress Disorder Checklist (PCL-5) | Measures symptoms in posttraumatic stress disorder. Total points 0-80, higher point indicates worse outcome. | Up to 1 year from baseline. |
| Adult ADHD Self-Report Scale (ASRS) | Measures symptoms in attention deficiency and hyperactivity disorder (ADHD). Minimum 0 point to maximum 72 points. Higher point indicates worse outcome. | Up to 1 year from baseline. |
| Perceived Stress Scale (PSS-14) | Measures perceived stress. Minimum 0 point to maximum 56 points. Higher point indicates worse outcome. | Up to 1 year from baseline. |
| EuroQol-Health-Related Quality of Life (EQ-5D-5L) | Assesses the current overall health related to wellbeing and function experienced by the patient. The questionnaire consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ visual analogue scale (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' between 0 and 100. The higher point indicates better outcome. | Up to 1 year from baseline. |
Plasma and serum samples derived from the participants will be submitted for proteomics analyses to identify one or more plasma/serum proteins whose concentration over the course of the study varies in relation to the treatment response.
| Up to 1 year from baseline. |
| Investigation of fatty acid profiles | A fatty acid profile in the serum or plasma will be analyzed using gas chromatography coupled to mass spectrometry. | Up to 1 year from baseline. |
| D000068099 |
| Trauma and Stressor Related Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |