An integrated Behavioural Activation intervention to improve depression among people with kidney failure undergoing haemodialysis: A feasibility study.

Background: People with kidney failure who receive haemodialysis are at a significantly higher risk of developing depression, however, there are limited effective and acceptable treatment options. In part, this is because medication (i.e. antidepressants) or appointments (for psychotherapy) can add to an already substantial treatment burden. Integrating mental health support into haemodialysis could improve the acceptability, and effectiveness, of treatments. Behavioural activation (BA) is an evidence-based low-intensity therapy for depression that can be delivered by trained non-specialists in a variety of services, including primary care. Delivering BA during routine haemodialysis treatment could provide an acceptable and cost-effective intervention to address depression, however, there is a lack of evidence demonstrating the effectiveness of BA in this population, and whether delivery of BA during haemodialysis treatment is feasible and acceptable. Aims: To determine the feasibility and acceptability of a cluster randomised controlled trial (RCT) of an integrated BA intervention to improve symptoms of depression for people receiving haemodialysis Methods: We will conduct a feasibility cluster RCT of an integrated BA intervention at 2 haemodialysis units, one in Hull and one in London. We will aim to recruit 26 participants from each site who have at least mild symptoms of depression measured by the PHQ-9, and we will use cluster randomisation so that participants will receive either the integrated BA intervention or usual care, depending on the days of the week participants attend the unit to receive haemodialysis. The intervention will involve 6-8 one-to-one sessions of BA at the bedside, during haemodialysis. We will collect clinical and healthcare resource use data at baseline and 3 months post-randomisation. We will conduct 35 semi-structured interviews with participants, their carers and healthcare workers at each of the sites, to understand the acceptability of the screening procedures, the BA intervention, and the trial design. Following completion of the feasibility study, we will carry out two generalisability workshops to explore how our findings could inform future policy, practice and research in other long-term conditions with similarly high levels of treatment burden and depression. Timelines: The proposed time frame is 24 months, from September 2025 to August 2027. Preliminary work: Draft protocol, submission for REC and HRA approval. Site set-up (Months 1-4) Feasibility study (4-16) Training intervention facilitators (3-7) Screening and recruitment (4-7) Data collection (6-13) Process evaluation interviews (11-14) Analysis (13-16) Generalisation workshops (13-20) Recruitment and organisation (13 - 19) Stakeholder workshops (19-20) Final report writing (17-24) Anticipated impact and dissemination: Findings will be disseminated in academic journals, conferences and to key stakeholders through social media, participant summaries, advocacy groups and third-sector organisations. We will develop a protocol and funding application for a definitive trial based on the findings from the feasibility study, and recommendations for policy and practice based on the outputs from our generalisation workshops. This research will result in improvements in the management of depression among people receiving haemodialysis, by identifying facilitators and novel strategies to improve the acceptability of screening and treatment.