Feasibility study for RCT of ACT for children with CFS/ME
Research type
Research Study
Full title
ExFACTR-Exploring the Feasibility of ACT for Children and young people with CFS/ME who have been receiving Treatment for more than 12 months or 12 sessions, in preparation for an RCT.
IRAS ID
283010
Contact name
Esther Crawley
Contact email
Sponsor organisation
University Of Bristol
Duration of Study in the UK
1 years, 0 months, 18 days
Research summary
This study forms pre-trial work for a randomised control trial of Acceptance and Commitment Therapy (ACT) for children and young people with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) who are still symptomatic after 12 months of or 12 sessions of either Activity Management (AM), Graded Exercise Therapy (GET) or Cognitive Behavioural Therapy for fatigue (CBT-f); at least 15% of patients do not recover after these treatments. This study aims to find out whether Acceptance and Commitment Therapy (ACT) is an acceptable and feasible treatment approach for this population.
Whilst there are no published randomised controlled trials (RCTs) investigating ACT for paediatric CFS/ME to date, there are suggestions that ACT is acceptable and feasible, and likely to be effective in adults with CSF/ME. Recent qualitative work (yet to be published, IRAS ID: 272229) undertaken by a member of our CFS/ME research team has shown that ACT would in theory be an acceptable treatment for children/young people with CSF/ME. Using these findings, this observational cohort feasibility study is the next step in pre-trial work to determine if ACT is indeed acceptable and feasible in practice and inform planning an RCT.
Patients at the Royal United Hospitals (RUH) Bath NHS Foundation Trust specialist paediatric CFS/ME service that have received more than 12 months or 12 sessions of treatment will be offered ACT.
Feasibility to recruit and retain will be assessed from the number of eligible patients recruited and retention rates. Acceptance of the intervention will be measured using post session questionnaires, semi-structured interview with participants and parents, and focus groups with healthcare professionals. Appropriate outcome measures will be assessed using data from qualitative interviews and an assessment of Patient Reported Outcome Measure completion rates in the cohort.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0392
Date of REC Opinion
4 Nov 2020
REC opinion
Favourable Opinion