A Randomised Multicentre Study Comparing Vigorous Group Aerobic Exercise vs. Group Leisure Activities for Mild to Moderate Depression in Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Lund University Hospital
- Enrollment
- 122
- Locations
- 7
- Primary Endpoint
- Change in Children's Depression Rating Scale- Revised (CDRS-R)
Study Overview
Brief 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.
Detailed Description
Depression is common in adolescence and prevalence is increasing. It is a major cause of disability worldwide and contributes to lower educational achievements, increased risk of substance abuse, suicide and cardiovascular disease. The effect of evidence based treatments with antidepressants or psychotherapy such as cognitive behavioural therapy (CBT) or interpersonal therapy (IPT) are modest. Selective serotonin uptake inhibitors (SSRIs) have shown effect on depression in children and adolescents, but the effect is often insufficient.
Aerobic exercise seems to have effect on depression in adolescents but studies have several shortcomings. Recruitment was mostly in non-clinical or primary care facilities, results are heterogeneous and adequate control groups are lacking. More data on qualitative, cost-effectiveness and biomarker aspects are clearly warranted.
OBJECTIVES:
Primary objective: To evaluate aerobic group exercise versus leisure group activities on clinician rated depression symptoms among adolescents in child and adolescent outpatient care with mild to moderate depressive disorder by measuring changes in Children's Depression Rating Scale- Revised (CDRS-R) after the intervention at 13 weeks from baseline.
Secondary objectives: To evaluate change in CDRS-R also at 26 weeks after baseline, i.e. after a period of no active intervention. Other secondary objectives are at both 13 and 26 weeks clinician rated Clinicial Global Impression - Severity (CGI-S) and Clinical Global Impression - Improvement scale (CGI-I) and function with Children Global Assessment Scale (C-GAS), self-rated symptoms (QIDS-A17-SR) and function with the Outcome Rating Scale (ORS), aerobic capacity measured by a submaximal aerobic capacity test, muscular strength measured by the isometric mid-thigh pull strength test, a hand grip strength test and muscular endurance by the one-leg sit-to-stand test, and body composition with a bioelectrical impedance analysis and presence or activity of selected biological markers of neuroprotection and neuroinflammation in blood samples.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The patient is at the follow-up interview instructed not to disclose any information about mode of treatment. All interviews are recorded.
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in Children's Depression Rating Scale- Revised (CDRS-R)
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)
Clinician administered interview about symptoms of depression, range 17 (best) - 113 (worst)
Secondary Outcomes
- Change in Quick Inventory of Depressive Symptomatology - Adolescent version, Self Report (QIDS-A17-SR)(Every two weeks during the 12 week intervention and monthly during the following year.)
- Change in Kynerunic Acid (KYNA)/3HK75 in blood samples(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Children Global Assessment Scale (C-GAS)(After intervention (at 13 weeks), at 26 weeks and at follow-up (at 52 weeks)])
- Clinical Global Impression - Severity(After intervention (at 13 weeks), at 26 weeks and at follow-up (at 52 weeks))
- Clinical Global Impression - Improvement(After intervention (at 13 weeks), at 26 weeks and at follow-up (at 52 weeks))
- Change in Outcome Rating Scale (ORS)(Every two weeks during the 12 week intervention and monthly during the following year.)
- Change in Aerobic capacity(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in muscular endurance(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in body composition(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in C-reactive Proteins (CRP) in blood samples(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Tumor Necrosis Factor (TNF)-alpha in blood samples(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Brain Derived Neurotrophic Factor (BDNF) in blood samples(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Soluble Interleukin (SIL)-2 receptor in blood samples(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Muscular strength(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in costs with the Treatment Inventory of Costs in Psychiatric Patients (Tic-P)(After intervention (at 13 weeks), at 26 weeks and at follow-up (at 52 weeks))
- Change in quality of life through Child Health Utility 9D (CHU9D)(After intervention (at 13 weeks), at 26 weeks and at follow-up (at 52 weeks))
- Change in Kynerunic Acid (KYN-ACID)75 in blood samples(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Insulin-like Growth Factor (IGF)-1 in blood samples(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Kynerunic Acid (KYNA) / Quinolinic Acid (QUIN)75 in blood samples(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Interleukin (IL)-6 in blood samples(After intervention (at 13 weeks) and at follow-up (at 52 weeks))