A Randomised Multicentre Study Comparing Vigorous Group Aerobic Exercise vs. Group Leisure Activities for Mild to Moderate Depression in Adolescents
Led by Lund University Hospital · Updated on 2025-03-26
122
Participants Needed
4
Research Sites
39 weeks
Total Duration
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AI-Summary
Brief Title
Who Can Participate
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Your Study Journey
Trial Site Locations
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Frequently Asked Questions
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Sponsors
L
Lund University Hospital
Lead Sponsor
R
Region Halland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of aerobic group exercise compared to leisure group activities in adolescents aged 13 to 17 with mild to moderate depression. The study aims to measure improvements in depression symptoms using the Children's Depression Rating Scale - Revised (CDRS-R) at 13 weeks after starting the interventions. Additional goals include assessing changes in clinical severity, self-reported depressive symptoms, physical fitness, biological markers related to neuroprotection and inflammation, cost-effectiveness, and understanding participants' experiences through interviews.
Participants will be randomly assigned to one of two groups: an aerobic exercise group or a leisure activities group. The aerobic exercise group will engage in 60-minute supervised sessions three times a week for 12 weeks, including aerobic, strength, and mixed training with gradually increased intensity. The leisure group will participate in non-heart rate increasing group activities, such as games and supportive discussions, at the same frequency and schedule. After 26 weeks, those in the leisure group will have the opportunity to join aerobic exercise sessions.
During the study, participants will complete assessments at baseline, 13 weeks, 26 weeks, and one year, including video evaluations of depression and functioning, physical fitness tests, body composition analysis, blood sampling for biological markers, and questionnaires on depressive symptoms, quality of life, and costs. Self-reported measures will be collected regularly during the intervention and follow-up periods. Safety monitoring will track adverse events related to depression and exercise. The entire trial spans one year of follow-up after the interventions, with ongoing data collection and evaluation.
CONDITIONS
Brief Title
Aerobic Versus Leisure Group for Adolescents With Depression
Who Can Participate
Age: 13Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
Diagnosed with mild to moderate depression according to DSM-5
Have received evaluation and basic psychosocial interventions for 4-8 weeks (minimum three visits) without at least 50% improvement
Aged between 13 and 17 years
You will not qualify if you...
Severe depression
Eating disorder
High risk for suicide
Intellectual disability
Engaged in physical activity at recommended health levels in the last 4 weeks (at least 150 min moderate or 75 min high intensity per week)
Recent adjustment of antidepressant medication within 4 weeks or stimulants within 2 weeks
Chronic physical illness preventing exercise
Need for interpreter
Social circumstances interfering with regular exercise schedule
Receiving concurrent psychotherapy
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Treatment
Duration - 12 weeks
Participants receive 12 weeks of either aerobic group exercise or group leisure activities, attending sessions three times a week for 60 minutes each under supervision.
Three sessions per week (in-person)
Follow-up
Duration - Up to 40 weeks after treatment (to complete one year total)
Participants are monitored for changes in depression symptoms, quality of life, physical measures, and biological markers through regular assessments up to one year after treatment.
Video call assessments at 13, 26, and 52 weeks; self-reported questionnaires every two weeks during treatment and monthly during follow-up
Trial Site Locations
Total: 4 locations
1
Region Halland
Halmstad, Sweden, 30290
Actively Recruiting
2
Prima Barn och vuxenpsykiatri AB (Stockholm-Handen)
Stockholm, Sweden, 11846
Actively Recruiting
3
PRIMA Barn och vuxenpsykiatri AB (Stockholm-Järva)
Moderate-to-vigorous group aerobic exercise versus group leisure activities for mild-to-moderate depression in adolescents: study protocol for a multicentre randomised controlled trial.
Rebecca Mortazavi, Maria Lalouni, Rebecca Grudin...
Aerobic exercise for adolescent outpatients with persistent major depression: Feasibility and acceptability of moderate to vigorous group exercise in a clinically referred sample.