Safety and Effectiveness of Behavioural Activation for Chronic Pain: A Protocol for a Systematic Review and Meta-Analysis of Randomised Controlled Trials

Background/Objectives: Chronic pain is a prevalent and complex condition associated with substantial physical, psychological, and social burden. Behavioural activation (BA), a structured psychological intervention originally developed for depression, may be relevant to chronic pain through its focus on reducing behavioural avoidance and increasing engagement in meaningful activities. Although BA has been applied in studies involving people with chronic pain, the safety and effectiveness of BA in this population have not been comprehensively synthesised. This systematic review and meta-analysis will examine the safety and effectiveness of BA for people with chronic pain. Methods: A systematic review and meta-analysis of literature evidence will be conducted. This protocol was developed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) and prospectively registered with PROSPERO (CRD420261379007). Randomised controlled trials (RCTs) evaluating BA or BA-based interventions for individuals with chronic pain will be eligible. MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Emcare, Web of Science Core Collection, Scopus and the Cochrane Central Register of Controlled Trials (CENTRAL), trial registries, and citation tracking will be searched. Two reviewers will independently screen records, extract data, and assess risk of bias using the Cochrane Risk of Bias 2 (RoB 2) tool. Where appropriate, meta-analysis will be conducted using a random-effects model. Pain intensity will be the primary outcome. Reported adverse events and other safety outcomes will be extracted and synthesised. Certainty of evidence will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: Not applicable; this is a protocol. Findings will be synthesised as specified in the Methods. Conclusions: The review will evaluate the effectiveness of BA with respect to pain intensity among people with chronic pain and examine what is known about its safety based on reported adverse events and other safety outcomes in existing trials. The review is expected to clarify the extent, consistency, and certainty of the randomised evidence on the effectiveness and safety of behavioural activation interventions for chronic pain and to identify gaps in adverse-event reporting and safety monitoring. Findings may inform clinical decision-making, intervention adaptation, and future research on BA for chronic pain.