Cognitive Behavioural Therapy for Renal Fatigue (BReF)
Research type
Research Study
Full title
Cognitive Behavioural Therapy (CBT) for Renal Fatigue (BReF): A feasibility pilot randomised-controlled trial of CBT for the management of fatigue in haemodialysis (HD) patients.
IRAS ID
223855
Contact name
Federica Picariello
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Fatigue affects 42 to 89% of people with Advanced Renal Disease (ARD) and it is added onto an already complex and challenging condition, and demanding treatment; therefore, it can further get in the way of life for patients with negative implications on their clinical outcomes. Currently, management of fatigue relies on pharmacological treatments or exercise; however, with limited benefit and not always suitable. There is evidence in support of psychological interventions for fatigue across chronic conditions. The aim of this trial is to assess whether a psychological fatigue intervention would be feasible, acceptable, and beneficial for fatigue in patients undergoing in-centre haemodialysis (HD). A total of 40 participants will be recruited from secondary care haemodialysis units. Following identification, screening, and consent, eligible participants will be asked to complete the baseline questionnaire. Once the baseline questionnaire is completed, patients will be randomly allocated to either the intervention or waiting-list control groups. Participants randomised to the intervention will receive the intervention over 4 to 6 weeks, with some therapist guidance. The intervention will follow a stepped-care model, with the delivery of basic intervention units, and additional units delivered to those engaging well. Participants in both groups will be asked to complete a follow-up self-report questionnaire 3-months post-randomization. Participants in the control group will then receive the intervention materials via post. A subgroup of participants, who received the intervention, will be interviewed about their experiences. This trial will not only help to assess whether there is evidence in support of a CBT-based intervention for fatigue in this setting, but it will also provide an insight into the mechanisms by which any changes in fatigue severity and fatigue-related functional impairment are likely to be gained.
REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/1406
Date of REC Opinion
12 Sep 2017
REC opinion
Further Information Favourable Opinion