The aim of the feasibility study is to ascertain whether a full-scale definitive study is feasible. The objectives are to:
- Finalise development of the intervention and control, including the Education Component (with Behaviour Change Techniques) and the intervention manual.
- Finalise development of intervention training programmes for staff
- Examine the feasibility of delivering the intervention across 3 sites
- Establish the potential adherence and engagement to the intervention by young people
- Establish potential reach and representativeness
- Examine the feasibility of delivering a randomised trial at scale
- The findings will be used to refine the intervention and study delivery for the full-scale trial.
Young people, aged 13-17, diagnosed with depression/low mood, from Child & Adolescent Mental Health Services (CAMHS) and GP practices within the catchment area of three study sites in Norfolk (Norfolk and Suffolk NHS Foundation Trust), Hertfordshire (Hertfordshire Partnership University NHS Foundation Trust and Hertfordshire Community NHS Trust covering Watford and Stevenage) and Bedfordshire (East London NHS Foundation Trust covering Luton & Dunstable).
We are currently only able to consider young people via self-referral that are living in the catchment area of the services provided by one of the three NHS Trusts supporting the study. This may change for the main trial.
Due to the COVID-19 pandemic, all group sessions are currently being delivered online to ensure that we meet with current government and medical advice and to protect the health and safety of participants and research staff.
The young people will continue to receive their usual health care and will be allocated randomly to one of three groups:
- High intensity exercise, through vigorous activities (e.g. boxercise, interval training)
- Low intensity exercise, through moderate activities (e.g. chair based exercises, strengthening or pilates exercises)
- An active control of social non-exercise activities (e.g. quizzes, Pictionary)
The young people in groups 1 & 2 will be offered 2 x 60-minute exercise sessions per week for 12 weeks. The young people in group 3 will also meet for 2 x 60-minute sessions each week. All groups will receive additional support on healthy living. All sessions will be delivered by Registered Exercise Professionals (REP). A mental health support worker (MHSW) will also be present at each session to provide support for the young people.
Taking part in the groups may lead to an improvement in low mood or depression. It is hoped that the information from this phase of the study will help to determine if a larger trial is possible. In the long-term, this might show that the READY exercise groups are helpful for young people with depression. This may mean that young people can be offered an exercise group as an alternative to drug treatment or talk therapy for treating depression. It’s difficult for some people to discuss personal things. If participants get upset whilst taking part, the researchers will stay with them until they feel better and make sure they know where to go for support if they need it. The exercises are safe for most young people, but they should not take part if they have been told by a doctor not to exercise. With any exercise programme there is a small risk of minor injuries e.g. pulled muscles or sprains. More serious injuries that can be associated with exercising e.g. fractures or ligament damage, are very rare.
The feasibility study is expected to run October 2020 to May 2021.