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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Physical exercise as described before.
Relaxation therapy as described before.
Department of Psychiatry, University hospital Örebro
Örebro, Sweden
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: Change of the score from the baseline to the score at 1 year.
Cognitive function: Trail Making Test Part A&B
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year from baseline.