OHC-TTP version 1.0
Research type
Research Study
Full title
A single-centre, non-blinded, randomised controlled trial comparing the tailored treatment programme (OHC-TTP), comprising nutritional therapy, psychoeducation, neurolingistic programming, and emotional freedom technique interventions, with Cognitive Behavioural Therapy (CBT) for the management of Chronic Fatigue Syndrome (CFS): A feasibility study.
IRAS ID
213427
Contact name
Basant Puri
Contact email
Sponsor organisation
Cambridge Advanced Research Alliance
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Chronic Fatigue Syndrome (CFS) is a complex disorder characterised by periods of extreme fatigue and ‘flu-like symptoms. It is currently estimated to affect 0.2-0.5% of the UK population. Patients have reported the use of complementary and alternative medicine (CAMs) helpful in the management of their symptoms. However, research into the benefit of CAMs is currently lacking. This study is a single-centre, non-blinded, randomised controlled trial (RCT) which aims to determine the feasibility and acceptability of a CAMs treatment to patients for the management of symptoms associated with CFS. This study will compare the use of a CAMs tailored treatment programme known as the Optimum Health Clinic's tailored treatment programme (OHC-TTP) - with Cognitive Behavioural Therapy (CBT). The OHC-TTP comprises nutritional therapy, psychoeducation, neuro-linguistic programming (NLP), and emotional freedom technique (EFT) interventions. The programme is delivered over 12-months using face-to-face 3-day workshop, face-to-face remote telephone and/or video conferencing consultations with an OHC Nutritional Therapist and OHC practitioner and online resources. Components of the OHC-TTP will be tailored to the individual patient by the OHC practitioner and Nutritional Therapist.
Potentially eligible patients will be identified through GP practice participant identification centres (PICs), receive a pre-screening telephone interview, and be invited to attend a screening appointment. Eligible participants will be randomised to receive either the OHC-TTP or CBT (CBT). A total of 70 patients will be recruited to trial, 35 per arm. This study will answer questions relating to the feasibility and acceptability of the OHC-TTP as an intervention for the management of CFS symptoms and inform the design of a full-scale RCT. This will be achieved through the analysis of data relating the recruitment and retention of patients, and completion of trial measures.
REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/1463
Date of REC Opinion
17 Jul 2019
REC opinion
Further Information Favourable Opinion