The Effect of Exercise on Preventing Depression in Young People

Sponsor
Guangzhou Psychiatric Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04816617
Collaborator
Shanghai Mental Health Center (Other), King's College London (Other)
370
1
2
25.5
14.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aerobic exercise intervention
  • Behavioral: Psycho-education
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
370 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Multi-center, 12-month,Parallel-group, Randomised Controlled Exercise Trial in Young People With Subthreshold Depression
Actual Study Start Date :
Oct 21, 2021
Anticipated Primary Completion Date :
May 20, 2023
Anticipated Study Completion Date :
Dec 6, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Onset of Major depressive Disorder (MDD) [month 6 and month 12]

    Kiddie-Sads-Present and Lifetime Version (K-SADS-PL)

  2. Changes from baseline in CES-DC at month 6 [month 6 and month 12]

    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

  1. Change in Cognitive function from baseline [Month 3,6 and month 12]

    Cognitive function is measured by THINC-it tool, a tool for cognitive assessment.

  2. Levels of inflammatory biomarkers from baseline [Month 3, 6 and month 12]

    inflammatory biomarkers (IL-6, CRP etc) will be analyzed using ELISA

  3. Brain structural and functional changes over time [month 3,6, or 12]

    Multimodal 3T MRI will be used

  4. Occurrence of Non-suicidal self-injury and suicidal behavior [Month 6 and month 12]

  5. Physical activity level [Month 6, 9 and 12]

    The International Physical Activity Questionnaire - Short Form (IPAQ - SF) will be used to assess physical activity level

  6. Electroencephalograph (EEG) scalp signal changes over time [Month 3, 6 and 12]

    Brain activity will be measured by the EEG

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The first Huaiji middle school Shaoxing Guangdong China

Sponsors and Collaborators

  • Guangzhou Psychiatric Hospital
  • Shanghai Mental Health Center
  • King's College London

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kangguang Lin, MD.PhD, Guangzhou Psychiatric Hospital
ClinicalTrials.gov Identifier:
NCT04816617
Other Study ID Numbers:
  • Exercise and MDD prevention
First Posted:
Mar 25, 2021
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kangguang Lin, MD.PhD, Guangzhou Psychiatric Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022