Evaluating cranial electrotherapy stimulation for anxiety associated with breathlessness in palliative care: a mixed-methods feasibility study

Objectives To explore the acceptability and tolerability of cranial electrotherapy stimulation (CES) using Alpha-Stim AID as a potential intervention for anxiety associated with breathlessness in people with advanced chronic respiratory disease. Methods A multicentre, mixed-methods, non-randomised interventional feasibility study with a parallel usual-care control group. Participants were adults with chronic respiratory disease and significant anxiety and breathlessness symptoms (assessed via Integrated Palliative Outcome Scale) receiving care from hospice services. The intervention groups used Alpha-Stim AID for eight weeks either at a fixed or personalised dose, followed by a four-week follow-up period. This feasibility study was not powered to assess clinical efficacy. Results 12.5% of screened patients at the primary site were eligible, and 29 unique participants were recruited. Three participants withdrew from the study (10.3%), none of which were attributable to CES. Most adverse events were mild, with headache reported frequently across control and intervention groups. Outcome measure completion was high, with data missingness below 6.4%. Numerical rating scales of anxiety and breathlessness fluctuated daily and remained broadly static, whereas GAD-7 scores assessing anxiety improved over time across all groups. This feasibility study was not powered to assess clinical efficacy. Conclusion CES using Alpha-Stim AID was deliverable within hospice services and was generally acceptable and tolerable among participants who enrolled. Our findings support further evaluation which should involve a fully-powered randomised controlled trial against a sham device to determine whether CES provides clinically meaningful improvements in anxiety for this patient population.