Aerobic Versus Leisure Group for Adolescents With Depression

Summary

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

• Depressive Disorder, Major

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

Sponsors & Collaborators

• Region Halland

  collaborator OTHER

• Halmstad University

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• The Rydberg Laboratory for Applied Sciences, Halmstad, Sweden

  collaborator UNKNOWN

• Region Skane

  collaborator OTHER

• PRIMA Barn- och Vuxenpsykiatri AB

  collaborator UNKNOWN

• Lund University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-28

Primary Completion

2025-06-10

Completion

2026-03-10

Countries

• Sweden

Study Locations