Physical Exercise for Treatment of Depression and Anxiety - RCT

Depression Clinical Trial

— FYPO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04714528
• Other study ID #: 273723
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 87
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Other:
• Physical Exercise
Physical exercise as described before.
• Relaxation Therapy
Relaxation therapy as described before.

Locations

Country	Name	City	State
Sweden	Department of Psychiatry, University hospital Örebro	Örebro

Sponsors (4)

Lead Sponsor	Collaborator
Region Örebro County	Karolinska Institutet, Örebro University, Sweden, Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Bjorngrim S, van den Hurk W, Betancort M, Machado A, Lindau M. Comparing Traditional and Digitized Cognitive Tests Used in Standard Clinical Evaluation - A Study of the Digital Application Minnemera. Front Psychol. 2019 Oct 18;10:2327. doi: 10.3389/fpsyg.2019.02327. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in gut microbiomes	The fecal samples will be analyzed for microbial composition using 16S microbiome analysis, metabolomics and Next Generation Sequencing.	Up to 1 year from baseline.
Other	Investigation of inflammatory biomarkers profile	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.	Up to 1 year from baseline.
Other	Investigation of fatty acid profiles	A fatty acid profile in the serum or plasma will be analyzed using gas chromatography coupled to mass spectrometry.	Up to 1 year from baseline.
Primary	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.	Change of the score from the baseline to the score at 12 weeks.
Primary	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.	Change of the score from the baseline to the score at 1 year.
Primary	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.	Change of the score from the baseline to the score at 12 weeks.
Primary	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.	Change of the score from the baseline to the score at 1 year.
Primary	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.	Change of the score from the baseline to the score at 12 weeks.
Primary	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.	Change of the score from the baseline to the score at 1 year.
Secondary	Cognitive function: Trail Making Test Part A&B	Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.	Comparison of results between baseline and week 12.
Secondary	Cognitive function: Trail Making Test Part A&B	Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.	Comparison of results between baseline and year 1.
Secondary	Cognitive function: Symbol Digit Modalities Test	Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.	Comparison of results between baseline and week 12.
Secondary	Cognitive function: Symbol Digit Modalities Test	Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.	Comparison of results between baseline and year 1.
Secondary	Cognitive function: Corsi Block-Tapping Test forward	Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.	Comparison of results between baseline and week 12.
Secondary	Cognitive function: Corsi Block-Tapping Test forward	Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.	Comparison of results between baseline and year 1.
Secondary	Cognitive function: Rey Auditory Verbal Learning Test	Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.	Comparison of results between baseline and week 12.
Secondary	Cognitive function: Rey Auditory Verbal Learning Test	Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.	Comparison of results between baseline and year 1.
Secondary	Cognitive function: Stroop test	Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.	Comparison of results between baseline and week 12.
Secondary	Cognitive function: Stroop test	Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.	Comparison of results between baseline and year 1.
Secondary	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.	Up to 1 year from baseline.
Secondary	Posttraumatic Stress Disorder Checklist (PCL-5)	Measures symptoms in posttraumatic stress disorder. Total points 0-80, higher point indicates worse outcome.	Up to 1 year from baseline.
Secondary	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.	Up to 1 year from baseline.
Secondary	Perceived Stress Scale (PSS-14)	Measures perceived stress. Minimum 0 point to maximum 56 points. Higher point indicates worse outcome.	Up to 1 year from baseline.
Secondary	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.	Up to 1 year from baseline.