Aerobic Versus Leisure Group for Adolescents With Depression

The aim is to evaluate aerobic group exercise versus leisure group activities in adolescents with mild to moderate depression. Primary outcome is Children's Depression Rating Scale - Revised (CDRS-R). Secondary outcomes are Clinical Global Impressions - Severity and Improvement scales (CGI), self-reported Quick Inventory of Depression Symptomatology (QIDS- A17-SR), the self-reported Outcome Rating Scale (ORS), clinician rated Children Global Assessment Scale (C-GAS), aerobic capacity (VO2max), muscular strength, body, Body Mass Index (BMI), presence or activity of selected biological markers of neuroprotection and neuroinflammation in blood samples and a cost evaluation rated by parents with Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (Tic-P) and the Child Health Utility (CHU9D) to facilitate estimation of Quality Adjusted Life Years. Further objectives are qualitative interviews to explore adolescents' experiences of the intervention as well as how their health and lifestyle are influenced and a validation of QIDS- A17-C and QIDS- A17-SR versus CDRS-R will be performed.

NCT Number	NCT05076214
Lead Sponsor	Lund University Hospital Collaborators: Region Halland, Halmstad University, Karolinska University Hospital, The Rydberg Laboratory for Applied Sciences, Halmstad, Sweden, Region Skane, PRIMA Barn- och Vuxenpsykiatri AB
Conditions	Depressive Disorder, Major
Enrollment	122 participants
Start Date	2022-02-28
Primary Completion	2025-06-10 (estimated)
Study Completion	2026-03-10 (estimated)
Updated on ClinicalTrials.gov	2025-03-26