Depression, Anxiety
Conditions
Keywords
Post Traumatic Stress Disorder, Attention Deficit Hyperactivity Disorder, Exercise, Bipolar disorder, Cognitive functions, Biomarkers, Fatty acids, Cytokines, Neurotrophins, Accelerometer, Microbiota, Metabolomics, Lipidomics
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.
Interventions
OTHERPhysical Exercise
Physical exercise as described before.
OTHERRelaxation Therapy
Relaxation therapy as described before.
Sponsors
Örebro University, Sweden
Uppsala University
Karolinska Institutet
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom improvement in depression | Change of the score from the baseline to the score at 12 weeks. | 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. |
| Symptom improvement in anxiety | Change of the score from the baseline to the score at 12 weeks. | 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. |
| Subjective symptom improvement in depression | Change of the score from the baseline to the score at 12 weeks. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Cognitive function: Trail Making Test Part A&B | Comparison of results between baseline and week 12. | Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore. |
| Cognitive function: Symbol Digit Modalities Test | Comparison of results between baseline and week 12. | 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 week 12. | 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 week 12. | 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 week 12. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Investigation of inflammatory biomarkers profile | 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. |
| Investigation of fatty acid profiles | Up to 1 year from baseline. | A fatty acid profile in the serum or plasma will be analyzed using gas chromatography coupled to mass spectrometry. |
| Changes in gut microbiomes | Up to 1 year from baseline. | The fecal samples will be analyzed for microbial composition using 16S microbiome analysis, metabolomics and Next Generation Sequencing. |
Countries
Sweden
Outcome results
None listed