Actively Recruiting

Phase Not Applicable
Age: 13Years - 17Years
All Genders
ID05076214

A Randomised Multicentre Study Comparing Vigorous Group Aerobic Exercise vs. Group Leisure Activities for Mild to Moderate Depression in Adolescents

Led by Lund University Hospital · Updated on 2025-03-26

122

Participants Needed

4

Research Sites

39 weeks

Total Duration

On this page

Sponsors

L

Lund University Hospital

Lead Sponsor

R

Region Halland

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the effects of aerobic group exercise compared to leisure group activities in adolescents aged 13 to 17 with mild to moderate depression. The study aims to measure improvements in depression symptoms using the Children's Depression Rating Scale - Revised (CDRS-R) at 13 weeks after starting the interventions. Additional goals include assessing changes in clinical severity, self-reported depressive symptoms, physical fitness, biological markers related to neuroprotection and inflammation, cost-effectiveness, and understanding participants' experiences through interviews. Participants will be randomly assigned to one of two groups: an aerobic exercise group or a leisure activities group. The aerobic exercise group will engage in 60-minute supervised sessions three times a week for 12 weeks, including aerobic, strength, and mixed training with gradually increased intensity. The leisure group will participate in non-heart rate increasing group activities, such as games and supportive discussions, at the same frequency and schedule. After 26 weeks, those in the leisure group will have the opportunity to join aerobic exercise sessions. During the study, participants will complete assessments at baseline, 13 weeks, 26 weeks, and one year, including video evaluations of depression and functioning, physical fitness tests, body composition analysis, blood sampling for biological markers, and questionnaires on depressive symptoms, quality of life, and costs. Self-reported measures will be collected regularly during the intervention and follow-up periods. Safety monitoring will track adverse events related to depression and exercise. The entire trial spans one year of follow-up after the interventions, with ongoing data collection and evaluation.

CONDITIONS

Brief Title

Aerobic Versus Leisure Group for Adolescents With Depression

Who Can Participate

Age: 13Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with mild to moderate depression according to DSM-5
  • Have received evaluation and basic psychosocial interventions for 4-8 weeks (minimum three visits) without at least 50% improvement
  • Aged between 13 and 17 years
Not Eligible

You will not qualify if you...

  • Severe depression
  • Eating disorder
  • High risk for suicide
  • Intellectual disability
  • Engaged in physical activity at recommended health levels in the last 4 weeks (at least 150 min moderate or 75 min high intensity per week)
  • Recent adjustment of antidepressant medication within 4 weeks or stimulants within 2 weeks
  • Chronic physical illness preventing exercise
  • Need for interpreter
  • Social circumstances interfering with regular exercise schedule
  • Receiving concurrent psychotherapy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Treatment

Duration - 12 weeks

Participants receive 12 weeks of either aerobic group exercise or group leisure activities, attending sessions three times a week for 60 minutes each under supervision.

Three sessions per week (in-person)

Follow-up

Duration - Up to 40 weeks after treatment (to complete one year total)

Participants are monitored for changes in depression symptoms, quality of life, physical measures, and biological markers through regular assessments up to one year after treatment.

Video call assessments at 13, 26, and 52 weeks; self-reported questionnaires every two weeks during treatment and monthly during follow-up

Trial Site Locations

Total: 4 locations

1

Region Halland

Halmstad, Sweden, 30290

Actively Recruiting

2

Prima Barn och vuxenpsykiatri AB (Stockholm-Handen)

Stockholm, Sweden, 11846

Actively Recruiting

3

PRIMA Barn och vuxenpsykiatri AB (Stockholm-Järva)

Stockholm, Sweden, 11846

Actively Recruiting

4

Region Halland

Varberg, Sweden, 43343

Actively Recruiting

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Research Team

H

Håkan Jarbin, MD, PhD

R

Rebecca Mortazavi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Moderate-to-vigorous group aerobic exercise versus group leisure activities for mild-to-moderate depression in adolescents: study protocol for a multicentre randomised controlled trial.

Rebecca Mortazavi, Maria Lalouni, Rebecca Grudin...

https://pubmed.ncbi.nlm.nih.gov/35820753

Aerobic exercise for adolescent outpatients with persistent major depression: Feasibility and acceptability of moderate to vigorous group exercise in a clinically referred sample.

Håkan Jarbin, Kristina Höglund, Gudmundur Skarphedinsson...

https://pubmed.ncbi.nlm.nih.gov/33858215

Empowered and engaged: Group exercise for adolescent depression - perspectives from adolescents, parents and healthcare professionals.

Rebecca Mortazavi, Rebecca Andersson, Håkan Jarbin...

https://pubmed.ncbi.nlm.nih.gov/38313468