Digitally-enabled self-experiments in general practice for evaluating the effectiveness of non-pharmacological, self-management interventions for persistent pain: Protocol for single case experiments

Background Non-pharmacological, self-management interventions are often recommended for general practice patients with persistent pain, a distressing, costly and heterogenous condition with variable responses to treatment interventions. Single-case experimental designs ("self-experiments") evaluate intervention effectiveness at the individual level. StudyU is an open-source digital platform designed to help patients undertake these self-experiments. Objectives To investigate the feasibility and acceptability (for patients, practitioners and other practice staff) of integrating digitally-enabled, withdrawal/reversal self-experiments in the general practice care of patients with persistent pain. Methods We will recruit 50 patients from a large Australian general practice. Participants will trial a self-selected, self-management intervention (such as a physical activity, mindfulness practice, or online, self-guided cognitive behavioural therapy) approved by their general practitioner (GP), and use the StudyU app to rate the daily impact of their pain over the 10-week study period. The primary clinical outcome of the self-experiments is pain interference (measured using the modified Brief Pain Inventory) and tested for its mean difference between usual routine and intervention conditions. Clinical reports are generated for the patient and their GP. We will use validated measures of app usability and acceptance, pre/post measures of patient self-efficacy, quality of life, health service use and self-reported health, individual interviews informed by Normalisation Process Theory, and a nested process evaluation to examine the feasibility and acceptability for patients and practice staff of embedding these self-experiments in general practice care. Results The research was funded in September 2023, funding and other agreements were completed by December 2024, and patient recruitment is scheduled to start in January 2025. Conclusion Digitally-enabled self-experiments testing non-pharmacological treatment effectiveness may empower patients to self-manage persistent pain and adopt personally effective non-pharmacological interventions, in partnership with their GPs, and provide a model for integrating other new technology into the general practice care of patients with other chronic conditions.