An interventional study of Aerobic exercise intervention and Psycho-education in Subthreshold Depression, Exercise and Clinically-well, sponsored by Guangzhou Psychiatric Hospital. Completed at 1 site in China. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Guangzhou Psychiatric Hospital · Not applicable, Interventional, and Prevention
It is estimated that approximately 30% of child and adolescents manifest subthreshold depression (including other specified depressive disorder and unspecified depressive disorder), which can further develop into major depression with as high as 25%-50% within one year. The cognitive development of adolescents is a critical area of research, given its significant implications for academic performance, mental health, and overall well-being. During adolescence, the brain undergoes substantial structural and functional changes, particularly in regions associated with executive function, memory, and processing speed. These changes provide a unique opportunity to explore interventions that can support and enhance cognitive development. One such promising intervention is physical exercise. Adolescence is characterized by rapid cognitive growth, including improvements in executive functions such as planning, decision-making, and inhibitory control. These cognitive abilities are essential for academic success and social interactions. However, this period also presents risks for cognitive and emotional disturbances, making it vital to identify effective strategies to promote healthy cognitive development. Despite the promising evidence, there is a need for more rigorous research, particularly long-term randomized controlled trials (RCTs), to establish the causal relationship between exercise and cognitive function in adolescents, including those with sub-threshold depression. Most existing studies have focused on short-term interventions or specific cognitive tasks, leaving a gap in our understanding of the sustained effects of exercise over an extended period. Additionally, the transition from supervised to unsupervised exercise and its impact on adherence and cognitive outcomes is underexplored. There is also a need to evaluate the potential of exercise as a preventive strategy against the development of major depressive disorder in this vulnerable population. Additionally, evidence suggests that participants with lower baseline levels of physical activity may experience more significant cognitive improvements from exercise interventions than those with higher baseline activity levels. This highlights the importance of considering baseline physical activity levels when assessing the effectiveness of exercise on cognitive outcomes.
This study will particularly focus on the cognitive domains of attention, memory, and processing speed. These domains are critical for academic success and daily functioning and are often impacted in adolescents with sub-threshold depression. Previous research has shown that these domains are particularly responsive to physical exercise interventions.
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 monthly. 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 cognition and prevention depression in young people with or without subthreshold depression.
Exclusion Criteria:
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
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
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.
Changes from baseline in Attention measure by Choice Reaction Time task (CRT) incorporated into THINC-it®
Attention will be measured by the Choice Reaction Time task (CRT).
Time frame: month 12
The rate of occurrence of MDD
Kiddie-Sads-Present and Lifetime Version (K-SADS-PL)
Time frame: Month 6 and month 12
Levels of inflammatory biomarkers from baseline
inflammatory biomarkers (IL-6, CRP etc) will be analyzed using ELISA
Time frame: Month 6 and month 12
Occurrence of Non-suicidal self-injury and suicidal behavior
Time frame: 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
Time frame: Month 6 and 12
P Wave changes over time
Brain activity will be detected by Electroencephalograph (EEG)
Time frame: Month 6 and 12
New onset of subthreshold depression in healthy volunteers
subthreshold depression is defined by DSM-5 Other specified Depressive Disorder and Unspecified Depressive Disorder
Time frame: Month 6 and 12
Changes from baseline in memory measured N-back memory task (N-BACK)
N-back memory task (N-BACK) was used to measure short-term memory.
Time frame: month 6 and month 12
Changes from baseline in subjective cognition measured by Perceived Deficits Questionnaire 5 (PDQ-5)
Perceived Deficits Questionnaire 5 (PDQ-5) is a subjective measure, which broadly evaluates attention/concentration, planning/organisation, as well as retrospective and prospective memory.
Time frame: Month 6 and 12
Changes from baseline in Processing Speed.
Digit Symbol Substitution Test (DSST) was used to measure Processing Speed.
Time frame: Month 6 and 12
Changes from baseline in executive function.
Trail Making Test-B (TMT-B) was used to measure Executive function.
Time frame: Month 6 and 12
Changes from baseline in Attention measure by Choice Reaction Time task (CRT)
Attention measure by Choice Reaction Time task (CRT)
Time frame: month 6
Plan to share: Undecided
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Guangzhou Psychiatric Hospital