Physical Exercise for Treatment of Depression and Anxiety - RCT (FYPO)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Anxiety
• Intervention / Treatment: Other: Physical Exercise; Other: Relaxation Therapy

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden
    • Department of Psychiatry, University hospital Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical Exercise Group; 45 minutes of aerobic, high intensity group training, three times per week during a 12-week period.	Other: Physical Exercise; Physical exercise as described before.
Other: Relaxation Group; 45 minutes of relaxation therapy once per week for 12 weeks.	Other: Relaxation Therapy; Relaxation therapy as described before.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Region Örebro County
• Collaborators: Karolinska Institutet; Uppsala University; Örebro University, Sweden
• Investigators: Principal Investigator: Yvonne Freund-Levi, MD, PhD, Region Örebro County/Örebro University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Microbiota; Metabolomics; Attention Deficit Hyperactivity Disorder; Biomarkers; Cytokines; Neurotrophins; Bipolar disorder; Accelerometer; Lipidomics; Fatty acids; Post Traumatic Stress Disorder; Cognitive functions
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 273723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No