Comparing aerobic exercise and leisure activities for adolescents with depression
A Randomised Multicentre Study Comparing Vigorous Group Aerobic Exercise vs. Group Leisure Activities for Mild to Moderate Depression in Adolescents
This study tests whether group aerobic exercise helps teenagers with mild to moderate depression feel better compared to doing leisure activities over 13 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | Lund University Hospital Academic / other |
| Locations | 4 sites (Halmstad and 3 other locations) |
| Trial ID | NCT05076214 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of aerobic group exercise compared to leisure group activities in adolescents diagnosed with mild to moderate depression. The primary outcome is measured using the Children's Depression Rating Scale - Revised (CDRS-R) after a 13-week intervention period. Secondary outcomes include various clinician and self-reported measures of depression, physical fitness assessments, and biological markers related to neuroprotection and neuroinflammation. The study also aims to gather qualitative data on adolescents' experiences and conduct a cost-effectiveness analysis.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 with mild to moderate depression who have not responded adequately to initial psychosocial interventions.
Not a fit: Patients with severe depression, eating disorders, or those at high risk for suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological intervention option that effectively reduces depressive symptoms in adolescents.
How similar studies have performed: Previous studies have shown promising results for aerobic exercise in treating depression in adolescents, but this study aims to address gaps in methodology and control groups.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * DSM-5 mild to moderate depression * who have received evaluation and basic psychosocial interventions for 4-8 weeks (minimum three visits) without response, i.e. not achieved improvement by at least 50 % as assessed from clinical records Exclusion Criteria: * Severe depression * Eating disorder * High risk for suicide * Intellectual disability * Actual physical activity the last four weeks meeting the level for sustained health by American College of Sports Medicine, i.e. at least 150 min per week of moderate intensity or 75 min per week of high intensity38 * Adjustment of antidepressant medication within the last four weeks or stimulants the last two weeks * Chronic somatic illness precluding exercise * In need of interpreter * Social circumstances interfering with a regular exercise schedule * Concomitant psychotherapy
Where this trial is running
Halmstad and 3 other locations
- Region Halland — Halmstad, Sweden (Recruiting)
- Prima Barn och vuxenpsykiatri AB (Stockholm-Handen) — Stockholm, Sweden (Recruiting)
- PRIMA Barn och vuxenpsykiatri AB (Stockholm-Järva) — Stockholm, Sweden (Recruiting)
- Region Halland — Varberg, Sweden (Recruiting)
Study contacts
- Study coordinator: Håkan Jarbin, MD, PhD
- Email: hakan.jarbin@regionhalland.se
- Phone: +46706778006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.