The Effect of Exercise on Preventing Depression in Young People

A Multi-center， 12-month，Parallel-group, Randomised Controlled Exercise Trial in Young People With Subthreshold Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Major Depression; Subthreshold Depression
• Intervention / Treatment: Behavioral: Aerobic exercise intervention; Behavioral: Psycho-education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 370
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kangguang Lin, MD,PhD; Phone Number: 86-02081268189; Email: linkangguang@163.com

Study Locations

• China
  • Guangdong
    • Shaoxing, Guangdong, China
      • Recruiting
      • The first Huaiji middle school
      • Contact: Kangguang Lin, MD, Ph.D; Phone Number: 8613560360144; Email: klin@gzhmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic Exercise; 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.	Behavioral: Aerobic exercise intervention; 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.
Placebo Comparator: Psycho-education; It consists of 6 sections of psycho-education, with topics covering mood regulations and mental well-being. Approximately 1 section in every two months.	Behavioral: Psycho-education; It consists of 6 sections of psycho-education, with topics covering mood regulations and mental well-being. Approximately 1 section in every two months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of Major depressive Disorder (MDD)	Kiddie-Sads-Present and Lifetime Version (K-SADS-PL)	month 6 and month 12
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.	month 6 and month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive function from baseline	Cognitive function is measured by THINC-it tool, a tool for cognitive assessment.	Month 3,6 and month 12
Levels of inflammatory biomarkers from baseline	inflammatory biomarkers (IL-6, CRP etc) will be analyzed using ELISA	Month 3, 6 and month 12
Brain structural and functional changes over time	Multimodal 3T MRI will be used	month 3,6, or 12
Occurrence of Non-suicidal self-injury and suicidal behavior		Month 6 and month 12
Physical activity level	The International Physical Activity Questionnaire - Short Form (IPAQ - SF) will be used to assess physical activity level	Month 6, 9 and 12
Electroencephalograph (EEG) scalp signal changes over time	Brain activity will be measured by the EEG	Month 3, 6 and 12

Collaborators and Investigators

• Sponsor: Guangzhou Psychiatric Hospital
• Collaborators: King's College London; Shanghai Mental Health Center
• Investigators: Study Director: Kangguang Lin, MD,PhD, The Affiliated Brain Hospital of Guangzhou Medical University; Principal Investigator: Tifei Yuan, PhD, Shanghai Mental Health Center; Study Chair: Kwok-Fai So, PhD, Jinan University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Anticipated): May 20, 2023
• Study Completion (Anticipated): December 6, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Subthreshold depression, aerobic exercise, Major depression, Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: Exercise and MDD prevention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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