Development of a biopsychosocial hybrid intervention to support patients following a complex lower-limb trauma

Aims: Complex lower-limb trauma is associated with substantial long-term physical and psychological morbidity. Access to integrated psychological support remains inconsistent. This study describes the development of Pain Rehabilitation to Optimize Major Orthopaedic Trauma REcovery (PROMOTE), a theory-based, hybrid (website plus one-to-one support) biopsychosocial intervention. Methods: Development followed the Medical Research Council framework for complex interventions and is reported in accordance with the GUIDance for the rEporting of intervention Development (GUIDED) checklist. This included: 1) an evidence review to identify modifiable psychosocial risk factors and theoretical models; 2) content coproduction with an expert advisory group including multidisciplinary clinicians and patient representatives, alongside independent patient interviews; and 3) iterative development and user testing of a low-intensity, scalable intervention. The intervention integrates the Common-Sense Model of Self-Regulation with cognitive behavioural therapy. Results: PROMOTE comprises four brief healthcare professional contact sessions delivered over eight weeks and an interactive, personalized website. The website is structured into five sections: 1) psychoeducation about the injury, pain, stress, and recovery; 2) cognitive behavioural techniques; 3) coping strategies; 4) recovery planning; and 5) a personalized profile. Content includes multimedia resources, interactive exercises, and personalized feedback. Iterative feedback from patients and clinicians led to improvements in navigation, language, pacing, and engagement. Conclusion: PROMOTE is a coproduced, theory-informed, scalable biopsychosocial intervention designed to address unmet psychological needs following complex lower-limb trauma. The intervention was evaluated in a feasibility randomized controlled trial to assess acceptability and engagement.