Aerobic Versus Leisure Group for Adolescents With Depression
ConditionDepressive Disorder, Major
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Aerobic exercise in group
BehavioralThe 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
Leisure activities in group
BehavioralThe 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
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: Aerobic exercise in groupExperimental treatment 1 intervention
Group B: Leisure activities in groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Children's Depression Rating Scale- Revised (CDRS-R)
Clinician administered interview about symptoms of depression, range 17 (best) - 113 (worst)
Time frame
After intervention (at 13 weeks = primary endpoint) but also at 26 weeks (still blinded)and at follow-up (at 52 weeks, non-blinded)Secondary outcomes
1
Change in Quick Inventory of Depressive Symptomatology - Adolescent version, Self Report (QIDS-A17-SR)
Self report form about symptoms of depression, range 0 (best) - 27 (worst)
Time frame
Every two weeks during the 12 week intervention and monthly during the following year.2
Clinical Global Impression - Severity
Clinician determined overall measure of severity pf psychopathology, values ranging from 1 (normal and best) to 7 (among the most extremely ill patients and worst)
Time frame
After intervention (at 13 weeks), at 26 weeks and at follow-up (at 52 weeks)3
Clinical Global Impression - Improvement
Clinician determined overall measure of change from initiation of treatment, values ranging from 1 (very much improved and best) to 7 (very much worse and worst)
Time frame
After intervention (at 13 weeks), at 26 weeks and at follow-up (at 52 weeks)4
Change in Children Global Assessment Scale (C-GAS)
Clinician administered interview about psychosocial function, 1(worst) - 100 (best
Time frame
After intervention (at 13 weeks), at 26 weeks and at follow-up (at 52 weeks)]Sponsors and contacts
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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
Source ClinicalTrials.gov