Aerobic Versus Leisure Group for Adolescents With Depression
Recruiting · NCT05076214 · Interventional (participants receive a specific treatment) · Lead sponsor: Lund University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
4 locations listed.
- Region Halland - Halmstad, Sweden
- Prima Barn och vuxenpsykiatri AB (Stockholm-Handen) - Stockholm, Sweden
- PRIMA Barn och vuxenpsykiatri AB (Stockholm-Järva) - Stockholm, Sweden
- Region Halland - Varberg, Sweden