Physical Exercise for Treatment of Depression and Anxiety - RCT

Study Overview
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Brief Summary
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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.

Official Title
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Physical Activity as Treatment for Depression and Anxiety Towards Affordable Preventive Healthcare - a Randomised Controlled Study (RCT)

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Other: Physical Exercise
* Other: Relaxation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Score ≥12 on MADRS or score ≥16 on BAI Inhabitant i Örebro County, Sweden BMI ≥18 kg/m^2 Exclusion Criteria: Diagnosis of chronic psychotic disease or ongoing psychotic episode. Ongoing manic state of bipolar disorder Severe somatic disease or condition where high intensity exercise is contraindicated Difficulty with reading, hearing or understanding the Swedish language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical Exercise Group<br>45 minutes of aerobic, high intensity group training, three times per week during a 12-week period. | Other: Physical Exercise<br>* Physical exercise as described before.<br>|
| Other: Relaxation Group<br>45 minutes of relaxation therapy once per week for 12 weeks. | Other: Relaxation Therapy<br>* Relaxation therapy as described before.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 
| Investigation of gut biomarkers | The fecal samples will be analyzed for biomarkers of microbial composition, inflammation and gut barrier function using 16S microbiota analysis, metabolomics and Next Generation Sequencing. | Up to 1 year from baseline. | 
| Investigation of inflammatory biomarkers | The inflammatory biomarkers will be analyzed using ELISA and Luminex. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Traumatic Stress Disorder, Attention Deficit Hyperactivity Disorder, Exercise, Bipolar disorder, Cognitive functions, Biomarkers, Fatty acids, Cytokines, Neurotrophins, Accelerometer, Microbiota, Metabolomics, Lipidomics