Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jan 10, 2020
Date Accepted: May 14, 2020
Testing the feasibility of recruiting adolescents with CFS/ME to Internet-delivered therapy: Internal pilot within a randomised controlled trial (the ‘FITNET-NHS’ trial)
ABSTRACT
Background:
Chronic fatigue syndrome (CFS/ME) in adolescents is common and disabling. UK teenagers are more likely to recover if they access specialist care, but most do not have access to a local specialist CFS/ME service. Delivering treatment remotely via the internet could improve access to treatment.
Objective:
To assess: i) the feasibility of recruitment and retention into a trial of internet-delivered specialist treatment for adolescent CFS/ME ii) the acceptability of trial processes and the two online treatments (to inform continuation to full trial).
Methods:
Design: Internal pilot for the initial 12 months of a full randomised controlled trial, with integrated qualitative methods (analysis of recruitment consultations and participant and clinician interviews). Setting: Remotely-delivered recruitment and treatment from a specialist paediatric CFS/ME treatment service within a south-west UK hospital. Participants: Adolescents (aged 11-17 years) from across the UK with a diagnosis of CFS/ME and no access to local specialist treatment were referred by their GP to the treatment centre. Eligibility assessment and recruitment were conducted via remote methods (telephone and online) and participants were randomised to one of two online treatments. Interventions: FITNET-NHS, an online modular CFS/ME-specific Cognitive Behaviour Therapy program (designed to be used by young people and their parents) supported by individualised clinical psychologist e-consultations. The comparison, Skype-delivered Activity Management with a CFS/ME clinician (mainly physiotherapist/occupational therapist). Both treatments were intended to last up to 6 months. Primary outcomes: Number of participants recruited (per out-of-area referrals received between 1 November 2016 to 31 October 2017), and proportion providing 6-month outcome data; qualitative outcomes indicating acceptability of trial processes and treatments.
Results:
89 young people (59% of 150 potentially eligible referrals) and their parents/carers were recruited and 75 (84% of 89) provided 6-month outcome data. Overall, online treatment was felt to be acceptable, however, participants and clinicians described both the advantages and disadvantages of remote methods.
Conclusions:
Recruiting young people (and parents/carers) into a randomised controlled trial of online treatment via remote methods is feasible and acceptable. Specialist treatment delivered at home via the Internet is feasible and acceptable, though some families prefer to travel across the UK for face-to-face treatment. Clinical Trial: International Standard Randomized Controlled Trial Number (ISRCTN) registered, 4 August, 2016: ISRCTN18020851
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.