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Active, Not Recruiting

NCT Number: NCT04714528

Physical Exercise for Treatment of Depression and Anxiety - RCT

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depression Anxiety Anxiety Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Motor Activity Neurodevelopmental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, University hospital Örebro

Örebro, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

Other

Physical exercise as described before.

relaxation therapy

Other

Relaxation therapy as described before.

Primary outcomes

  1. Symptom improvement in depression

    Time frame: 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.

  2. 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.

  3. Symptom improvement in anxiety

    Time frame: 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.

  4. 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.

  5. Subjective symptom improvement in depression

    Time frame: 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.

  6. 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

  1. Cognitive function: Trail Making Test Part A&B

    Time frame: Comparison of results between baseline and week 12.

    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  2. Cognitive function: Trail Making Test Part A&B

    Time frame: Comparison of results between baseline and year 1.

    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  3. Cognitive function: Symbol Digit Modalities Test

    Time frame: Comparison of results between baseline and week 12.

    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  4. Cognitive function: Symbol Digit Modalities Test

    Time frame: Comparison of results between baseline and year 1.

    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  5. Cognitive function: Corsi Block-Tapping Test forward

    Time frame: Comparison of results between baseline and week 12.

    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  6. Cognitive function: Corsi Block-Tapping Test forward

    Time frame: Comparison of results between baseline and year 1.

    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  7. Cognitive function: Rey Auditory Verbal Learning Test

    Time frame: Comparison of results between baseline and week 12.

    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  8. Cognitive function: Rey Auditory Verbal Learning Test

    Time frame: Comparison of results between baseline and year 1.

    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  9. Cognitive function: Stroop test

    Time frame: Comparison of results between baseline and week 12.

    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  10. Cognitive function: Stroop test

    Time frame: Comparison of results between baseline and year 1.

    Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.

  11. Clinical Global Impression (CGI) severity scale

    Time frame: 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.

  12. Posttraumatic Stress Disorder Checklist (PCL-5)

    Time frame: Up to 1 year from baseline.

    Measures symptoms in posttraumatic stress disorder. Total points 0-80, higher point indicates worse outcome.

  13. Adult ADHD Self-Report Scale (ASRS)

    Time frame: 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.

  14. Perceived Stress Scale (PSS-14)

    Time frame: Up to 1 year from baseline.

    Measures perceived stress. Minimum 0 point to maximum 56 points. Higher point indicates worse outcome.

  15. EuroQol-Health-Related Quality of Life (EQ-5D-5L)

    Time frame: 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.

Other outcomes

  1. Changes in gut microbiomes

    Time frame: Up to 1 year from baseline.

    The fecal samples will be analyzed for microbial composition using 16S microbiome analysis, metabolomics and Next Generation Sequencing.

  2. Investigation of inflammatory biomarkers profile

    Time frame: 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.

  3. Investigation of fatty acid profiles

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Karolinska Institutet
  • Uppsala University
  • Örebro University, Sweden

Registry information

Official study title

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

Acronym: FYPO

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Jan 19, 2021
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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