Actively Recruiting

Phase Not Applicable
Age: 13Years - 17Years
All Genders
NCT05076214

Aerobic Versus Leisure Group for Adolescents With Depression

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

122

Participants Needed

4

Research Sites

210 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

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.

CONDITIONS

Official 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...

  • Adolescents aged 13 to 17 years
  • 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 as recorded clinically
Not Eligible

You will not qualify if you...

  • Severe depression
  • Eating disorder
  • High risk for suicide
  • Intellectual disability
  • Engaged in physical activity in the last four weeks meeting recommended health levels (150 min/week moderate or 75 min/week high intensity)
  • Adjusted antidepressant medication within the last four weeks or stimulants within the last two weeks
  • Chronic physical illness preventing exercise
  • Need for an interpreter
  • Social circumstances that interfere with a regular exercise schedule
  • Receiving psychotherapy

AI-Screening

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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

CONTACT

R

Rebecca Mortazavi, MD

CONTACT

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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Aerobic Versus Leisure Group for Adolescents With Depression | DecenTrialz