Cognitive-behavioural therapy (CBT) for renal fatigue (BReF): a feasibility randomised-controlled trial of CBT for the management of fatigue in haemodialysis (HD) patients

Abstract

Introduction: Fatigue is one of the most common and disabling symptoms in end-stage kidney disease, particularly among in-centre haemodialysis patients. This two-arm parallel group feasibility randomised controlled trial will determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of a cognitive-behavioural therapy (CBT)-based intervention for fatigue among in-centre haemodialysis patients.

Methods: We aim to recruit 40 adult patients undergoing in-centre haemodialysis at secondary care outpatient dialysis units, who meet clinical levels of fatigue. Patients will be randomised individually (using a 1:1 ratio) to either a 4-6 weeks' CBT-based intervention (intervention arm) or to a waiting-list control (control arm). The primary feasibility outcomes include descriptive data on numbers within each recruiting centre meeting eligibility criteria, rates of recruitment, numbers retained postrandomisation and treatment adherence. To assess the potential benefits of the cognitive-behavioural therapy for renal fatigue intervention, secondary self-report outcomes include measures of fatigue severity (Chalder Fatigue Questionnaire), fatigue-related functional impairment (Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index), depression (Patient Health Questionnaire-9) and anxiety (Generalised Anxiety Disorder-7). Changes in fatigue perceptions (Brief Illness Perception Questionnaire), cognitive and behavioural responses to fatigue (Cognitive and Behavioural Responses to Symptoms Questionnaire), sleep hygiene behaviours (Sleep Hygiene Index) and physical activity (International Physical Activity Questionnaire-short form) will also be explored. These self-report measures will be collected at baseline and 3 months postrandomisation. Nested qualitative interviews will be conducted postintervention to explore the acceptability of the intervention and identify any areas in need of improvement. The statistician and assessor will be blinded to treatment allocation.

Ethics and dissemination: A National Health Service (NHS) Research Ethics Committee approved the study. Any amendments to the protocol will be submitted to the NHS Committee and study sponsor.

Trial registration number: ISRCTN91238019;Pre-results.

Keywords: cognitive behavioural therapy; dialysis; fatigue; kidney failure; quality of life.

Figure 1.

Cognitive-behavioural therapy model of renal fatigue. This diagram illustrates the different clinical, social situational and psychological factors that contribute to fatigue in this setting.

Figure 2

Anticipated flow of participants through the study. Number of patients approached for screen, those who consented, and those who were assessed for eligibility will be recorded. Eligible patients will be invited to complete a baseline questionnaire (T0). After completion of the baseline questionnaire, participants will be randomised. Participants in the intervention arm will receive the intervention over 4–6 weeks. All participants will complete a follow-up questionnaire at 3 months postrandomisation (T1). Participants in the intervention arm will be invited to take part in a qualitative evaluation interview at the end of their involvement in the study. After completion of the follow-up questionnaire, participants in the control arm will receive the intervention materials.

Figure 3

Structure and content of the intervention. The intervention will follow a stepped approach over 4–6 weeks, accompanied by 3–5 sessions with a therapist. In level 1, participants will cover chapters 1, 2, a relevant chapter identified in the assessment and chapter 8. Level 2 focuses on cognitive therapy.