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

INTERVENTION: The intervention is a tailored CBT‐based self‐management intervention with therapist support. The purpose of this intervention is to target individuals’ fatigue beliefs and behaviours in order to facilitate coping with renal fatigue. This study is a two‐armed parallel feasibility randomised‐controlled trial (RCT) with a nested qualitative study to explore the feasibility, acceptability, and potential benefits of CBT‐based intervention for fatigue in haemodialysis. Participants are randomly allocated to the intervention group or the waiting list group. The structure of the intervention is stepped, consisting of a basic unit, where all participants cover four chapters of a self‐management manual and this is accompanied by three sessions with a therapist, and an additional unit, for those engaging well, where an additional two chapters are covered with a therapist in two telephone sessions on changing unhelpful thoughts. The intervention lasts approximately between four to six weeks. Participants complete a baseline questionnaire before randomisation and a follow‐up questionnaire at 3‐months post‐randomisation. Participants allocated to the waiting‐list control continue to receive their usual care without any additional support. However, at the end of their participation in the study, they receive the therapy materials to complete on their own. Participants in both groups are asked to complete a follow‐up self‐report questionnaire three‐months post‐randomisation. A qualitative study is nested within this feasibility trial. A subgroup of participants, who received the intervention, are interviewed about their experiences of the intervention by an independent from the delivery of the intervention researcher. CONDITION: Specialty: Renal disorders, Primary sub‐specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Renal failure, Other/ General symptoms and signs ; Urological and Genital Diseases ; End‐Stage Kidney Disease patients receiving in‐centre haemodialysis PRIMARY OUTCOME: 1. Descriptive data on recruitment and retention rates and willingness to be randomised; 2. Degree of adherence to the intervention; INCLUSION CRITERIA: 1. Are over 18 years of age 2. Have a confirmed ARD diagnosis 3. Are experiencing clinical levels of fatigue defined as scoring >18 on the Chalder Fatigue Questionnaire, when using the continuous scoring (Chalder et al., 1993; White et al., 2011) 4. Have full verbal and written proficiency in English 5. Receiving in‐centre haemodialysis 6. Length of time on dialysis > 90 days 7. Are willing and able to take part in the study and intervention SECONDARY OUTCOME: 1. Fatigue severity is measured using the Chalder Fatigue Questionnaire (CFQ) at baseline and 3‐months post‐randomisation; 2. Fatigue‐related functional impairment is measured using the Work and Social Adjustment Scale (WSAS) at baseline and 3‐months post‐randomisation; 3. Depression is measured using the Patient Health Questionnaire‐9 (PHQ9) at baseline and 3‐months post‐randomisation; 4. Anxiety is measured using the the Generalised Anxiety Disorder‐7 (GAD7) at baseline and 3‐months post‐randomisation; 5. Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and 3‐months post‐randomisation; 6. Fatigue perceptions is measured using the Brief Illness Perceptions Questionnaire (BIPQ) at baseline and 3‐months post‐randomisation; 7. Cognitive and behavioural responses to fatigue is measured using the Cognitive and Behavioural Responses to Symptoms Questionnaire (CBSQ) at baseline and 3‐months post‐randomisation; 8. Sleep hygiene behaviours is measured using the Sleep Hygiene Index (SHI) at baseline and 3‐months post‐randomisation; 9. Physical activity as measured by the International Physical Activity Questionnaire (short‐form) (IPAQ‐SF) at baseline and 3‐months post‐randomisation; 10. Patient perceptions of the acceptability and usefulness of the intervention is assessed through the qualitative interviews. Qualitative interviews will be conducted by an independent from the trial researcher with a subset of participants who received the intervention following completion of the follow‐up questionnaire at 3‐months post‐randomisation.