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BACKGROUND Emotion dysregulation is key to the development and maintenance of chronic pain, feeding into a cycle of worsening pain and disability. Dialectical behavioural therapy (DBT), an approach which targets emotional processes through skills training to induce effective emotion regulation, could help people manage and mitigate the emotional and sensory aspects of chronic pain. A prior repeated measures single-case trial investigating a novel technologically driven intervention, iDBT-Pain (internet-delivered dialectical behavioural therapy for chronic pain), revealed promising findings to improve both emotion dysregulation and pain intensity. OBJECTIVE This randomised controlled trial will aim to examine the efficacy of iDBT-Pain in comparison to treatment-as-usual to reduce emotion dysregulation (primary outcome) for individuals with chronic pain after nine weeks and at 21-week follow-up. The secondary outcomes include pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, post-traumatic stress, coping, social cognition, sleep, life satisfaction and wellbeing. The trial will also examine the acceptability of the iDBT-Pain intervention to evaluate participants perspectives about this healthcare intervention for future development and testing. METHODS Forty-eight people with chronic pain will be randomly assigned to one of two conditions: treatment and treatment-as-usual. Participants in the treatment condition will receive iDBT-Pain, consisting of six live online sessions with a DBT skills trainer and the iDBT-Pain app to encourage skills practice. Participants in the treatment-as-usual condition will not receive iDBT-Pain but will still access their usual medication and health interventions. We predict that iDBT-Pain will improve the primary outcome of emotion dysregulation, and the secondary outcomes of pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, coping, social cognition, sleep, life satisfaction and wellbeing. A linear mixed model with random effect of individuals will be conducted to investigate differences between baseline, 9-week (primary endpoint) and 21-week (follow-up) assessments as a function of experimental condition. RESULTS Recruitment is planned to start in February 2023 with the start of the clinical trial planned for May 2023. Data collection for the final assessment is planned for November 2023. CONCLUSIONS If our hypothesis is confirmed, our findings will contribute to the evidence for the efficacy and acceptability of a viable intervention that may be used by healthcare professionals for people with chronic pain. The results will add to the chronic pain literature, to inform about the potential benefits of DBT and technologically driven interventions. CLINICALTRIAL Australian New Zealand Clinical Trials Registry: ACTRN12622000113752. |
