Project

A Randomised controlled trial of energetic activity for depression in young people – The READY Trial - MH07

Feasibility study: open for recruitment

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Summary

The READY Trial is a randomised controlled trial (RCT) of exercise in young people aged 13 – 17 years living with depression or low mood.

Background

Depression in young people is a serious problem that can lead to lifelong poor mental health and stigma. Depression is reported in around 20% of under 18s, and over half continue to be depressed into adulthood. Problems include difficulties at home and school, maintaining friendships and taking part in social activities, including exercise. Young people with depression often delay seeking psychological support. Antidepressants can help, but they have negative side effects.

Research shows that adults with depression benefit from exercise, but it is not known whether exercise is helpful for young people who are depressed. In addition,  the level of exercise required for a positive effect is not known and this information is important when deciding on treatment.

There is a need for high quality trials in this area to advise the design of exercise programmes to reduce depressive symptoms in young people, and to assess the effect of exercise intensity.

Project aims

The overall aim of this study is to find out whether exercise is an effective treatment for young people with depression and whether it is good value for money for the NHS.

We are currently testing the feasibility of the study design and aim to recruit 81 young people from Hertfordshire, Bedfordshire, Norfolk to test the recruitment of young people, attendance and exercise achieved, completion of questionnaires and the experience of participation in exercise and the research process. This will help us improve the study design.

Project activity

Young people assessed as suitable for exercise will continue to receive their usual health care and will be allocated randomly (e.g. throwing a dice) to one of 3 groups:

1. High-intensity exercise, through vigorous activities (e.g. football, dance)

2. Low-intensity exercise, through moderate activities (e.g. walking football/netball)

3. A control of social non-exercise based activities (playing games, watching films)

Participants will attend two 60-minute sessions per week for 12 weeks. All groups will receive behaviour change education and support. Sessions will be delivered by Registered Exercise Professionals (REPs) supported by Mental Health Support Workers (MHSWs).

Impact

We expect to add valuable knowledge about the clinical and cost-effectiveness of exercise as a treatment for depression in young people and its ‘real world’ application in the NHS and other services, along with a comparison between low intensity and high intensity exercise.

We expect to provide evidence for NHS policy makers, commissioners and clinicians, who are looking for evidence-based and cost-effective treatments for this specific group of young people, to offer as routine NHS care. This research will also add important knowledge about successful partnership working across the NHS and local community organisations, such as sports facilities, to improve mental health support for young people.

Papers and resources associated with this study 

Study website https://readytrial.co.uk/

Howlett et al. A randomised controlled trial of energetic activity for depression in young people (READY): a multi-site feasibility trial protocol.  Pilot and Feasibility Studies (2021) 7:6  https://rdcu.be/cc40m

Next steps

The READY trial is part of a 5-year project to be conducted in three phases over 56 months.

The feasibility study is currently underway.  Once this is completed, a pilot study will be conducted over 8 months in 8 locations with 150 young people in total. This phase will test whether the intervention and study design are working as intended.

The main trial will be completed over 30 months, in 8 locations, with 130 young people in each location (N=1044) to test effectiveness and cost-effectiveness.

Disclaimer

Funded by National Institute for Health Research.  The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Who is involved?

PI

Dr Daksha Trivedi, University of Hertfordshire

Dr David Wellsted, University of Hertfordshire

Collaborators

University of Hertfordshire:

Dr Lindsay Bottoms, exercise physiologist

Dr Lee David, academic GP & visiting fellow

Dr Julia Jones, Patient & Public Involvement

Dr Silvana Mengoni, Process evaluation

Dr Neil Howlett, exercise, behaviour change, psychology

Dr Shivani Sharma, Health inequalities

Ms Solange Wyatt, Clinical Trials Support Network

Hertfordshire Partnership University NHS Foundation Trust

Dr Mirza Kah, Consultant Psychiatrist

University of Bedfordshire

Dr Angel Chater, Behaviour change, psychology, exercise

Norfolk & Suffolk Foundation Trust:

Dr Jonathan Wilson, Consultant psychiatrist

Dr Tim Clarke, Research clinical psychologist

 

University of East Anglia

Dr Allan Clark, Norwich Clinical Trials Unit

Prof Andrew Jones, Public health, exercise

Dr Jamie Murdoch, Process evaluation

Dr Erika Sims, Norwich Clinical Trials Unit

Prof Ann Marie Swart, Director Norwich Clinical Trials Unit

David Turner, Health Economics

 

Community sports providers

Matt Corder, Active Luton, Bedfordshire

Andrew Garlick, Watford Football Club’s Community Sports and Education Trust

Stevie Bramble, Norwich City Community Sports Foundation  

Site Leads

Dr Tim Clarke

Norfolk and Suffolk NHS Foundation Trust

 

Dr Ella Beeson

Hertfordshire Partnership University NHS Foundation Trust

Hertfordshire Community NHS Trust

 

Dr Wendy O’Neill

East London NHS Foundation Trust 

Contact:

Dr Daksha Trivedi, University of Hertfordshire

d.trivedi@herts.ac.uk

Dr David Wellsted, University of Hertfordshire

d.m.wellsted@herts.ac.uk