search
Back to results

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

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical Exercise
Relaxation Therapy
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Post Traumatic Stress Disorder, Attention Deficit Hyperactivity Disorder, Exercise, Bipolar disorder, Cognitive functions, Biomarkers, Fatty acids, Cytokines, Neurotrophins, Accelerometer, Microbiota, Metabolomics, Lipidomics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, University hospital ÖrebroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Physical Exercise Group

Relaxation Group

Arm Description

45 minutes of aerobic, high intensity group training, three times per week during a 12-week period.

45 minutes of relaxation therapy once per week for 12 weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Cognitive function: Trail Making Test Part A&B
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Trail Making Test Part A&B
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Symbol Digit Modalities Test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Symbol Digit Modalities Test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Corsi Block-Tapping Test forward
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Corsi Block-Tapping Test forward
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Rey Auditory Verbal Learning Test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Rey Auditory Verbal Learning Test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Stroop test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Cognitive function: Stroop test
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Investigation of gut biomarkers
The fecal samples will be analyzed for biomarkers of microbial composition, inflammation and gut barrier function using 16S microbiota analysis, metabolomics and Next Generation Sequencing.
Investigation of inflammatory biomarkers
The inflammatory biomarkers will be analyzed using ELISA and Luminex.
Investigation of fatty acid profiles
A fatty acid profile in the serum or plasma will be analyzed using gas chromatography coupled to mass spectrometry.

Full Information

First Posted
November 6, 2020
Last Updated
January 15, 2021
Sponsor
Region Örebro County
Collaborators
Örebro University, Sweden, Uppsala University, Karolinska Institutet
search

1. Study Identification

Unique Protocol Identification Number
NCT04714528
Brief Title
Physical Exercise for Treatment of Depression and Anxiety - RCT
Acronym
FYPO
Official Title
Physical Activity as Treatment for Depression and Anxiety Towards Affordable Preventive Healthcare - a Randomised Controlled Study (RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Örebro County
Collaborators
Örebro University, Sweden, Uppsala University, Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Post Traumatic Stress Disorder, Attention Deficit Hyperactivity Disorder, Exercise, Bipolar disorder, Cognitive functions, Biomarkers, Fatty acids, Cytokines, Neurotrophins, Accelerometer, Microbiota, Metabolomics, Lipidomics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Exercise Group
Arm Type
Active Comparator
Arm Description
45 minutes of aerobic, high intensity group training, three times per week during a 12-week period.
Arm Title
Relaxation Group
Arm Type
Other
Arm Description
45 minutes of relaxation therapy once per week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Intervention Description
Physical exercise as described before.
Intervention Type
Other
Intervention Name(s)
Relaxation Therapy
Intervention Description
Relaxation therapy as described before.
Primary Outcome Measure Information:
Title
Symptom improvement in depression
Description
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.
Time Frame
Change of the score from the baseline to the score at 12 weeks.
Title
Symptom improvement in depression
Description
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.
Time Frame
Change of the score from the baseline to the score at 1 year.
Title
Symptom improvement in anxiety
Description
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.
Time Frame
Change of the score from the baseline to the score at 12 weeks.
Title
Symptom improvement in anxiety
Description
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.
Time Frame
Change of the score from the baseline to the score at 1 year.
Title
Subjective symptom improvement in depression
Description
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.
Time Frame
Change of the score from the baseline to the score at 12 weeks.
Title
Subjective symptom improvement in depression
Description
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.
Time Frame
Change of the score from the baseline to the score at 1 year.
Secondary Outcome Measure Information:
Title
Cognitive function: Trail Making Test Part A&B
Description
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time Frame
Comparison of results between baseline and week 12.
Title
Cognitive function: Trail Making Test Part A&B
Description
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time Frame
Comparison of results between baseline and year 1.
Title
Cognitive function: Symbol Digit Modalities Test
Description
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time Frame
Comparison of results between baseline and week 12.
Title
Cognitive function: Symbol Digit Modalities Test
Description
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time Frame
Comparison of results between baseline and year 1.
Title
Cognitive function: Corsi Block-Tapping Test forward
Description
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time Frame
Comparison of results between baseline and week 12.
Title
Cognitive function: Corsi Block-Tapping Test forward
Description
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time Frame
Comparison of results between baseline and year 1.
Title
Cognitive function: Rey Auditory Verbal Learning Test
Description
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time Frame
Comparison of results between baseline and week 12.
Title
Cognitive function: Rey Auditory Verbal Learning Test
Description
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time Frame
Comparison of results between baseline and year 1.
Title
Cognitive function: Stroop test
Description
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time Frame
Comparison of results between baseline and week 12.
Title
Cognitive function: Stroop test
Description
Cognitive functions are measured using digitized cognitive tests selected for depression in cooperation with Mindmore.
Time Frame
Comparison of results between baseline and year 1.
Title
Investigation of gut biomarkers
Description
The fecal samples will be analyzed for biomarkers of microbial composition, inflammation and gut barrier function using 16S microbiota analysis, metabolomics and Next Generation Sequencing.
Time Frame
Up to 1 year from baseline.
Title
Investigation of inflammatory biomarkers
Description
The inflammatory biomarkers will be analyzed using ELISA and Luminex.
Time Frame
Up to 1 year from baseline.
Title
Investigation of fatty acid profiles
Description
A fatty acid profile in the serum or plasma will be analyzed using gas chromatography coupled to mass spectrometry.
Time Frame
Up to 1 year from baseline.
Other Pre-specified Outcome Measures:
Title
Clinical Global Impression (CGI) severity scale
Description
Clinician's impression of total severity of the mental illness. Scale between 0 and 7, higher point indicates worse outcome.
Time Frame
Up to 1 year from baseline.
Title
Posttraumatic Stress Disorder Checklist (PCL-5)
Description
Measures symptoms in posttraumatic stress disorder. Total points 0-80, higher point indicates worse outcome.
Time Frame
Up to 1 year from baseline.
Title
Adult ADHD Self-Report Scale (ASRS)
Description
Measures symptoms in attention deficiency and hyperactivity disorder (ADHD). Higher point indicates worse outcome.
Time Frame
Up to 1 year from baseline.
Title
Perceived Stress Scale (PSS-14)
Description
Measures perceived stress. Higher point indicates worse outcome.
Time Frame
Up to 1 year from baseline.
Title
EuroQol-Health-Related Quality of Life (EQ-5D-5L)
Description
Assesses the current overall health related to wellbeing and function experienced by the patient.
Time Frame
Up to 1 year from baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne Freund-Levi, MD, PhD
Phone
+46 736841130
Email
yvonne.freund@oru.se
First Name & Middle Initial & Last Name or Official Title & Degree
Qiwei Zhai, MD
Phone
+46 790631305
Email
qiwei.zhai@regionorebrolan.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Freund-Levi, MD, PhD
Organizational Affiliation
Region Örebro County/Örebro University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University hospital Örebro
City
Örebro
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Freund-Levi, MD, PhD
Phone
+46 736841130
Email
yvonne.freund@oru.se
First Name & Middle Initial & Last Name & Degree
Qiwei Zhai, MD
Phone
+46 790631305
Email
qiwei.zhai@regionorebrolan.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31681117
Citation
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.
Results Reference
background

Learn more about this trial

Physical Exercise for Treatment of Depression and Anxiety - RCT

We'll reach out to this number within 24 hrs