Aerobic Versus Leisure Group for Adolescents With Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorLund University Hospital

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

122 Participants
are divided into 2 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