MAGENTA: Graded Exercise Therapy Vs Activity Management

Full title The feasibility and acceptability of conducting a trial investigating the effectiveness and cost effectiveness of Graded Exercise Therapy compared to Activity Management for paediatric CFS/ME: A feasibility randomised controlled trial
Research type Research study
IRAS ID 176764
Contact Name Esther Crawley
Contact Email esther.crawley@bristol.ac.uk
Sponsor organisation Royal United Hospitals Bath NHS Foundation Trust
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Research summary Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME) in children is relatively common affecting up to 2% of secondary school children. Although national guidance recommends that children with CFS/ME are offered either Cognitive Behavioural Therapy (CBT), Graded Exercise Therapy (GET) or Activity Management, there is no evidence for the effectiveness or cost effectiveness and acceptability of GET for children with CFS/ME. This study will investigate the feasibility and acceptability of conducting a Randomised Controlled Trial (RCT) to investigate the effectiveness and cost-effectiveness of Graded Exercise Therapy compared to Activity Management for the treatment of CFS/ME in children. We will interview participants, their parents, researchers and clinicians to improve the study and the interventions. If MAGENTA is feasible, we will move on to a full study and find out whether GET is effective and cost effective. The study will be conducted in three specialist services: Bath/Bristol, Cambridge and Newcastle. Children will be eligible if they have CFS/ME, are aged 8-17 and are not severely affected, are not referred for CBT at the first assessment and are able to attend follow up appointments. The study is funded by the NIHR.
REC Name South West - Frenchay Research Ethics Committee
REC Reference 15/SW/0124
REC Opinion

Further Information Favourable Opinion

Further Information Favourable Opinion

Date of REC Opinion 3 July 2015