People with kidney failure who receive haemodialysis experience substantially elevated rates of depression, but there is limited evidence to guide treatment specifically in this population. A notable barrier is the high treatment burden of regular dialysis sessions, which makes adding separate psychological treatment appointments impractical for many patients. Behavioural activation (BA) is an evidence-based, brief psychological therapy for depression that has been adapted for diverse clinical settings, but prior to the BEACH study it had not been evaluated for delivery during dialysis sessions.
The BEACH study aims to evaluate the feasibility and acceptability of conducting a cluster randomised controlled trial (cRCT) of intradialytic behavioural activation for people receiving haemodialysis who are experiencing symptoms of depression. Specific objectives are to test trial procedures (screening, recruitment, retention, outcome collection), assess the acceptability and delivery of the BA intervention in the dialysis setting, and determine the feasibility of collecting health-economic data required for a future definitive trial.
The protocol describes a pilot cluster randomised controlled trial alongside embedded qualitative and economic feasibility components. The pilot cRCT will recruit a planned sample of 52 participants across two sites. Clusters (as defined in the trial protocol) will be randomised to receive either intradialytic BA or usual care. Participants will be followed for three months to collect feasibility and preliminary outcome data.
Participants are adults receiving haemodialysis who are screening positive for symptoms of depression. The pilot will recruit 52 people across two sites; details on specific eligibility criteria and screening tools are provided in the full protocol. The study will record metrics relevant to feasibility: numbers screened, numbers eligible, recruitment rates, and participant retention over the three-month follow-up period.
The intervention tested is behavioural activation delivered during dialysis sessions (intradialytic BA). BA is a brief behavioural therapy that targets reduction in depressive symptoms by increasing engagement in meaningful and reinforcing activities. Delivering BA during dialysis aims to reduce the additional treatment burden on patients by integrating therapy into existing appointments. The protocol reports that the acceptability and practical delivery of BA in the dialysis environment will be evaluated as primary feasibility outcomes.
Participants in clusters randomised to the comparator arm will receive usual care provided in the dialysis setting. The protocol frames the trial as a pragmatic feasibility study, comparing intradialytic BA against the standard clinical practice and support available to patients receiving haemodialysis.
Key outcomes for this feasibility study include the practicability of screening and recruitment procedures, participant retention rates, and the completeness of clinical outcome measure data collection. The study will also assess the acceptability of the intervention to patients and staff, and will record any logistical or safety issues encountered when delivering therapy during dialysis.
A qualitative process evaluation is embedded in the protocol and will use semi-structured interviews with patients, healthcare professionals and carers. The qualitative component will explore experiences of participants and staff, identify barriers and facilitators to implementing intradialytic BA, and inform refinement of the intervention and trial procedures for a future definitive cRCT.
The protocol includes a feasibility economic evaluation to determine whether appropriate healthcare resource-use and cost data can be collected in this setting. The findings will inform the design of a full economic evaluation in a future powered trial, should progression criteria be met.
The BEACH protocol specifies that if the pilot demonstrates feasibility and acceptability—based on recruitment, retention, data completeness and stakeholder feedback—the next planned step is a definitive, adequately powered cluster RCT to determine the clinical effectiveness of intradialytic BA in people receiving haemodialysis and experiencing depression. That larger trial would also enable a full cost-effectiveness assessment.
The paper is published open access in PLoS One (2026 Aug 6;21(8):e0353407; DOI 10.1371/journal.pone.0353407) and is distributed under a Creative Commons Attribution license. The protocol lists authors, affiliations and declares competing interests: one author reports professional roles and prior honoraria unrelated to this work; the authors state adherence to journal policies on data and materials. The protocol is presented as a clinical trial protocol (feasibility study) and lists MeSH terms relevant to behaviour therapy, depression and renal dialysis.