Physical Exercise for Treatment of Depression and Anxiety - RCT
- Conditions
- AnxietyDepression
- Interventions
- Other: Relaxation TherapyOther: Physical Exercise
- Registration Number
- NCT04714528
- Lead Sponsor
- Region Örebro County
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 87
- Score ≥12 on MADRS or score ≥16 on BAI
- Inhabitant i Örebro County, Sweden
- BMI ≥18 kg/m^2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Relaxation Group Relaxation Therapy 45 minutes of relaxation therapy once per week for 12 weeks. Physical Exercise Group Physical Exercise 45 minutes of aerobic, high intensity group training, three times per week during a 12-week period.
- Primary Outcome Measures
Name Time Method Symptom improvement in anxiety 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 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 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 Outcome Measures
Name Time Method Cognitive function: Trail Making Test Part A&B Comparison of results between baseline and year 1. Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Corsi Block-Tapping Test forward Comparison of results between baseline and year 1. Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Rey Auditory Verbal Learning Test Comparison of results between baseline and year 1. Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Stroop test Comparison of results between baseline and year 1. Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Clinical Global Impression (CGI) severity scale Up to 1 year from baseline. Clinician's impression of total severity of the mental illness. Scale between 0 and 7, higher point indicates worse outcome.
EuroQol-Health-Related Quality of Life (EQ-5D-5L) Up to 1 year from baseline. 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.Posttraumatic Stress Disorder Checklist (PCL-5) Up to 1 year from baseline. Measures symptoms in posttraumatic stress disorder. Total points 0-80, higher point indicates worse outcome.
Adult ADHD Self-Report Scale (ASRS) Up to 1 year from baseline. Measures symptoms in attention deficiency and hyperactivity disorder (ADHD). Minimum 0 point to maximum 72 points. Higher point indicates worse outcome.
Cognitive function: Symbol Digit Modalities Test Comparison of results between baseline and year 1. Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Perceived Stress Scale (PSS-14) Up to 1 year from baseline. Measures perceived stress. Minimum 0 point to maximum 56 points. Higher point indicates worse outcome.
Trial Locations
- Locations (1)
Department of Psychiatry, University hospital Örebro
🇸🇪Örebro, Sweden