About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Severe depression
Eating disorder
High risk for suicide
Intellectual disability
Trial design
Treatments tested in this trial
- Aerobic exercise in group
- Leisure activities in group
Treatment groups
Sponsors and collaborators
Lund University Hospital
Lead sponsor
Region Halland
Collaborator
Halmstad University
Collaborator
Karolinska University Hospital
Collaborator
The Rydberg Laboratory for Applied Sciences, Halmstad, Sweden
Collaborator
Region Skane
Collaborator
PRIMA Barn- och Vuxenpsykiatri AB
Collaborator