Preventing Secondary Complications and Disability Among Patients with Acute Burn Injuries: The Safety, Meaning, Activation and Resilience Trial (SMART)

Importance: Burns are painful, life threatening and disfiguring. Severe psychological distress, pain and sleep disturbance are among the most common, enduring and disabling of secondary complications, however, no evidence based treatments exists for these complex problems in the acute burn care setting. Design: Randomized, controlled effectiveness trial, interventionist blinded to active condition, group assignment blinded to baseline status, groups stratified by history of pre-existing psychiatric disorder. Objectives. To develop the Safety, Meaning, Activation and Relaxation Training (SMART) protocol; To evaluate its short and long-term effectiveness, relative to viable placebo, Supportive Counseling (SC), in improving key mediators, and, enhancing health and function outcomes; To examine the relationship between costs and effectiveness of SMART relative to SC. Setting: A leading edge, State-dedicated, regional burn center in a major, metropolitan teaching hospital serving diverse residents from large urban settings, small towns and remote rural areas. Interventions: SMART (focused cognitive-behavioral therapy with training in anxiety and pain management, and sleep enhancing skills) will be contrasted with SC (non-directive empathy, warmth, positive regard). Primary Outcome Measures: Health (psychological distress, sleep, pain), function (physical, psychological, social), costs (direct and indirect).