Recruiting

Aerobic Versus Leisure Group for Adolescents With Depression

ClinicalTrials.gov IDNCT05076214

PhaseNA

Enrollment122

SponsorLund University Hospital

Age13 Years

SexALL

I'm interested View official listing

Conditions studied

Depressive Disorder, Major

About this study

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.

Interventions

Behavioral: Aerobic exercise in group — The goal with every new week should be making every workout a little bit harder than the week before. Strength sessions Week 1- 6: 12-18 repetitions (reps) x 2 set per exercise and muscle 30 seconds (s) rest between exercise Week 7-12: 10-12 reps x 3 set per exercise and muscle 20 s rest between exercises Adding weight with gym equipment or changing body position in the exercises to succeed with the rep scheme and making it harder as the group develop their physical and mental ability. Conditioning sessions Week 1- 6: 75 seconds work time x 1 set per exercise 30 seconds of rest between exercises Week 7-12: 50 seconds work time x 2 set per exercise 20 seconds of rest between exercises Mixed sessions Week 1- 6: 35 s work time per exercise 25 s rest between exercises x 2 rounds Week 7-12: 45 s work time per exercise 15 s rest between exercises x 2 rounds
Behavioral: Leisure activities in group — The control group will receive leisure activity in a group setting for one hour three times a week for 12 weeks. The sessions will be held at the same weekdays and about the same hours as the exercise group sessions. The same group leaders as in the exercise sessions will participate in leisure sessions and will support the adolescents through reminders and reassurance before and during the sessions to enhance adherence. The sessions will start with a check in on feelings, recent events and difficulties (i.e. supportive listening but not any interventions) followed by non heart rate increasing activities, such as playing games or cards together

Primary outcomes

Change in Children's Depression Rating Scale- Revised (CDRS-R) (After intervention (at 13 weeks = primary endpoint) but also at 26 weeks (still blinded)and at follow-up (at 52 weeks, non-blinded))

Eligibility information

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

Study locations

Region Halland, Halmstad, 30290 Sweden
Prima Barn och vuxenpsykiatri AB (Stockholm-Handen), Stockholm, 11846 Sweden
PRIMA Barn och vuxenpsykiatri AB (Stockholm-Järva), Stockholm, 11846 Sweden
Region Halland, Varberg, 43343 Sweden

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.