Physical Activity as Treatment for Depression and Anxiety Towards Affordable Preventive Healthcare - a Randomised Controlled Study (RCT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Region Örebro County
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Symptom improvement in anxiety
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Yvonne Freund-Levi
Associate Professor, M.D., Ph.D
Region Örebro County
Eligibility Criteria
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
Outcomes
Primary Outcomes
Symptom improvement in anxiety
Time Frame: Change of the score from the baseline to the score at 1 year.
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.
Symptom improvement in depression
Time Frame: Change of the score from the baseline to the score at 1 year.
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.
Subjective symptom improvement in depression
Time Frame: Change of the score from the baseline to the score at 1 year.
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.
Secondary Outcomes
- Cognitive function: Trail Making Test Part A&B(Comparison of results between baseline and year 1.)
- Cognitive function: Corsi Block-Tapping Test forward(Comparison of results between baseline and year 1.)
- Cognitive function: Rey Auditory Verbal Learning Test(Comparison of results between baseline and year 1.)
- Cognitive function: Stroop test(Comparison of results between baseline and year 1.)
- Clinical Global Impression (CGI) severity scale(Up to 1 year from baseline.)
- EuroQol-Health-Related Quality of Life (EQ-5D-5L)(Up to 1 year from baseline.)
- Posttraumatic Stress Disorder Checklist (PCL-5)(Up to 1 year from baseline.)
- Adult ADHD Self-Report Scale (ASRS)(Up to 1 year from baseline.)
- Cognitive function: Symbol Digit Modalities Test(Comparison of results between baseline and year 1.)
- Perceived Stress Scale (PSS-14)(Up to 1 year from baseline.)