Depression Mental and Behavioural Disorders
Conditions
Interventions
The young people will continue to receive their usual health care. Those suitable for exercise will be allocated randomly to one of three groups:
1. High-intensity exercise, through vigorous activitie
Sponsors
University of Hertfordshire
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be as inclusive as possible, any young person meeting the inclusion criteria for low mood or depression should be considered for the study. Low mood or depression does not need to be the primary diagnosis and comorbid conditions that do not preclude exercise should not be a barrier to inclusion. 1. Help-seeking adolescents aged 13-17 years with a CDI 2 score between 17 and 36, inclusive (mild to moderate symptoms) 2. Current treatment with antidepressants or other drug, or psychological therapy is allowed 3. Young person understands their role in the trial and is able to complete trial activities 4. Young person consent to participate, with consent from parent/carer for under 16s and consent of parent/carer to provide data 5. Parent/carer/guardian also taking part in the study 6. Young person and parent/carer is able to complete the questionnaires in English 7. Young person able to get to the site where the intervention will be held
Exclusion criteria
Exclusion criteria: 1. Considered unsuitable by the clinician screening for eligibility 2. Current treatment, or co-morbid conditions present contraindications to engaging in RCT or exercise 3. Active psychosis, significant substance abuse, self-harm, or suicidal ideation presenting significant risk (assessed as part of the DAWBA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As a feasibility study, there is no primary outcome. For the future main trial, the primary outcome will be depression measured using the Child Depression Inventory (2nd Edition) score, most likely at 4 months from baseline. For the feasibility study, the outcomes are listed as follows: 1. Referral rate recorded as the number of people referred for screening via any route by the end of recruitment 2. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by the end of recruitment 3. Attrition rate recorded as the number of participants who consent to participate that remain in the study until the end of follow-up at 26 weeks post randomisation 4. Attendance rate at the intervention sessions as a proportion of the total number of sessions by 12 weeks 5. Heart rate as measured using a heart rate monitor at each exercise session up to 12 weeks 6. Physical activity measured using an accelerometer as proportion of time active at baseline, 14 weeks and 26 weeks post randomisation 7. Adherence to the intervention protocol as captured by the intervention logs and rated against the adherence checklist by members of the study team at weekly intervention sessions up to 12 weeks and at 14 and 26 weeks post randomisation 8. Proportion of missing data will be reported as the percentage of recorded outcomes against those expected after account for withdrawal for each outcome separately at the end of follow-up at 26 weeks post randomisation 9. Adverse event rate recorded as the frequency, type (injury or clinical progression of depression) and severity of event by treatment arm at the end of follow-up at 26 weeks post randomisation 10. Estimate of resource use as measured through observation and study-specific questionnaire at the end of the follow-up at 26 weeks post randomisation 11. Reach and representativeness measured by the proportions of patients who are screened for participation and are randomised in comparison to the chara | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactMegan Smith
Outcome results
None listed