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The Effect of Exercise on Preventing Depression in Young People

Primary Purpose

Subthreshold Depression, Exercise, Major Depression

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aerobic exercise intervention
Psycho-education
Sponsored by
Guangzhou Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subthreshold Depression focused on measuring Subthreshold depression, aerobic exercise, Major depression, Intervention

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • There are two or more Diagnostic and Statistical Manual of Mental Disorder (DSM)-5 depressive symptoms, including at least one core symptom.
  • Any of the core symptoms of subclinical depressive syndrome lasts at least one week, with symptom manifestation ≥50% of the time.
  • CES-DC ≥16 points, Altman Self-Rated Mania Scale (ASRM) < 13 points.
  • 10~17 years old.

Exclusion Criteria:

  • Current or past DSM-5 criteria for major depressive disorder,Bipolar disorder, Schizophrenia.
  • With moderate or above suicide risk determined by Columbia-Suicide Severity Rating Scale (C-SSRS) (who will be referred to psychologist and/or psychiatrist for follow-up intervention)
  • Musculoskeletal problems such as arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising
  • A history of organic brain disease or brain trauma
  • Alcohol, drug or other psychoactive substance abuse or dependence
  • Currently enrolled in another exercise study
  • Any condition that would make exercise unsafe or unwise
  • Taking medication that interferes with heart rate response to exercise such as beta blockers

Sites / Locations

  • The first Huaiji middle schoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aerobic Exercise

Psycho-education

Arm Description

The whole exercise lasts for 12 months, consisted of 6-month supervised exercise and 6-month maintenance period. It is moderate -intensity exercise (60-80% Maximum heart rate), each time last for 30 mins (plus 10-minutes for warm-up and cool-down), 3-4 times a week, for the first six months, which will be supervised in person by physical educators and/or physical professionals. In the maintenance period, participants are asked to exercise at the same intensity and frequency, but will not be supervised in person by physical educators/professionals. They will receive reminder on a weekly basis and their physical activities be recorded by accelerometer. Types of exercise will be chosen according to individual school's facility and feasibility, including jogging, fast walking, badminton, running, football etc.

It consists of 6 sections of psycho-education, with topics covering mood regulations and mental well-being. Approximately 1 section in every two months.

Outcomes

Primary Outcome Measures

Onset of Major depressive Disorder (MDD)
Kiddie-Sads-Present and Lifetime Version (K-SADS-PL)
Changes from baseline in CES-DC at month 6
Center for Epidemiological Studies Depression Scale for Children (CES-DC) is a self rating scale and has been shown to be effective in groups aged 6-23. CES-DC is used to measure the depressive severity；its measured time range is within the past week. In this study, version of 20-items is used. The higher the score indicates the more severe the depression symptoms, the scale author recommends 15 points as the screening demarcation value.

Secondary Outcome Measures

Change in Cognitive function from baseline
Cognitive function is measured by THINC-it tool, a tool for cognitive assessment.
Levels of inflammatory biomarkers from baseline
inflammatory biomarkers (IL-6, CRP etc) will be analyzed using ELISA
Brain structural and functional changes over time
Multimodal 3T MRI will be used
Occurrence of Non-suicidal self-injury and suicidal behavior
Physical activity level
The International Physical Activity Questionnaire - Short Form (IPAQ - SF) will be used to assess physical activity level
Electroencephalograph (EEG) scalp signal changes over time
Brain activity will be measured by the EEG

Full Information

First Posted
March 23, 2021
Last Updated
March 24, 2022
Sponsor
Guangzhou Psychiatric Hospital
Collaborators
Shanghai Mental Health Center, King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT04816617
Brief Title
The Effect of Exercise on Preventing Depression in Young People
Official Title
A Multi-center， 12-month，Parallel-group, Randomised Controlled Exercise Trial in Young People With Subthreshold Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
December 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Psychiatric Hospital
Collaborators
Shanghai Mental Health Center, King's College London

4. Oversight

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

5. Study Description

Brief Summary
It is estimated that approximately 30% of child and adolescents manifest subthreshold depression, which can further develop into major depression with as high as 25%-50% within one year. The main aim of this trial is to investigate the effect of long-term exercise on preventing major depression and depressive symptoms in young people (aged 10-17 years old). Other aims include the underlying mechanisms of how aerobic exercise works and predictors for treatment response.
Detailed Description
This is multi-center, psycho-education randomized controlled trial, consisting of two periods with each of 6 months (i.e supervised and maintenance period). In the exercise intervention arm, during the first 6 months, participants will be asked to do moderate-intensity aerobic exercise 3-4 times a week, which will be supervised in person by physical educators/professionals. In the next 6-month maintenance period, participants will be asked to continue doing aerobic exercise at the same intensity and frequency, which will not be supervised in person by educators/professionals, but they will be sent reminders and report adherence weekly. All of the physical activity will be recorded by accelerometer at scheduled time points (e.g. the first week, 6 week, 3 month, 6 month, 9 month, 12 month). Psycho-education group will be given 6 sections of general psycho-education onsite and/or virtually dependent on the surroundings with regards to the impact of the COVID-19 pandemic. The main aim of this trial is to investigate the effect of long-term aerobic exercise on prevention depression in young people with subthreshold depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subthreshold Depression, Exercise, Major Depression
Keywords
Subthreshold depression, aerobic exercise, Major depression, Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
The whole exercise lasts for 12 months, consisted of 6-month supervised exercise and 6-month maintenance period. It is moderate -intensity exercise (60-80% Maximum heart rate), each time last for 30 mins (plus 10-minutes for warm-up and cool-down), 3-4 times a week, for the first six months, which will be supervised in person by physical educators and/or physical professionals. In the maintenance period, participants are asked to exercise at the same intensity and frequency, but will not be supervised in person by physical educators/professionals. They will receive reminder on a weekly basis and their physical activities be recorded by accelerometer. Types of exercise will be chosen according to individual school's facility and feasibility, including jogging, fast walking, badminton, running, football etc.
Arm Title
Psycho-education
Arm Type
Placebo Comparator
Arm Description
It consists of 6 sections of psycho-education, with topics covering mood regulations and mental well-being. Approximately 1 section in every two months.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise intervention
Intervention Description
The whole exercise lasts for 12 months, consisted of 6-month supervised exercise and 6-month maintenance period. It is moderate -intensity exercise (60-80% Maximum heart rate), each time last for 30 mins (plus 10-minutes for warm-up and cool-down), 3-4 times a week, for the first six months, which will be supervised in person by physical educators and/or physical professionals. In the maintenance period, participants are asked to exercise at the same intensity and frequency, but will not be supervised in person by physical educators/professionals. They will receive reminder on a weekly basis and their physical activities be recorded by accelerometer. Types of exercise will be chosen according to individual school's facility and feasibility, including jogging, fast walking, badminton, running, football etc.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-education
Intervention Description
It consists of 6 sections of psycho-education, with topics covering mood regulations and mental well-being. Approximately 1 section in every two months.
Primary Outcome Measure Information:
Title
Onset of Major depressive Disorder (MDD)
Description
Kiddie-Sads-Present and Lifetime Version (K-SADS-PL)
Time Frame
month 6 and month 12
Title
Changes from baseline in CES-DC at month 6
Description
Center for Epidemiological Studies Depression Scale for Children (CES-DC) is a self rating scale and has been shown to be effective in groups aged 6-23. CES-DC is used to measure the depressive severity；its measured time range is within the past week. In this study, version of 20-items is used. The higher the score indicates the more severe the depression symptoms, the scale author recommends 15 points as the screening demarcation value.
Time Frame
month 6 and month 12
Secondary Outcome Measure Information:
Title
Change in Cognitive function from baseline
Description
Cognitive function is measured by THINC-it tool, a tool for cognitive assessment.
Time Frame
Month 3,6 and month 12
Title
Levels of inflammatory biomarkers from baseline
Description
inflammatory biomarkers (IL-6, CRP etc) will be analyzed using ELISA
Time Frame
Month 3, 6 and month 12
Title
Brain structural and functional changes over time
Description
Multimodal 3T MRI will be used
Time Frame
month 3,6, or 12
Title
Occurrence of Non-suicidal self-injury and suicidal behavior
Time Frame
Month 6 and month 12
Title
Physical activity level
Description
The International Physical Activity Questionnaire - Short Form (IPAQ - SF) will be used to assess physical activity level
Time Frame
Month 6, 9 and 12
Title
Electroencephalograph (EEG) scalp signal changes over time
Description
Brain activity will be measured by the EEG
Time Frame
Month 3, 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: There are two or more Diagnostic and Statistical Manual of Mental Disorder (DSM)-5 depressive symptoms, including at least one core symptom. Any of the core symptoms of subclinical depressive syndrome lasts at least one week, with symptom manifestation ≥50% of the time. CES-DC ≥16 points, Altman Self-Rated Mania Scale (ASRM) < 13 points. 10~17 years old. Exclusion Criteria: Current or past DSM-5 criteria for major depressive disorder,Bipolar disorder, Schizophrenia. With moderate or above suicide risk determined by Columbia-Suicide Severity Rating Scale (C-SSRS) (who will be referred to psychologist and/or psychiatrist for follow-up intervention) Musculoskeletal problems such as arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising A history of organic brain disease or brain trauma Alcohol, drug or other psychoactive substance abuse or dependence Currently enrolled in another exercise study Any condition that would make exercise unsafe or unwise Taking medication that interferes with heart rate response to exercise such as beta blockers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kangguang Lin, MD,PhD
Phone
86-02081268189
Email
linkangguang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kangguang Lin, MD,PhD
Organizational Affiliation
The Affiliated Brain Hospital of Guangzhou Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tifei Yuan, PhD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwok-Fai So, PhD
Organizational Affiliation
Jinan University
Official's Role
Study Chair
Facility Information:
Facility Name
The first Huaiji middle school
City
Shaoxing
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kangguang Lin, MD, Ph.D
Phone
8613560360144
Email
klin@gzhmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of Exercise on Preventing Depression in Young People

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