| Study Summary: |
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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, group assignment blinded to baseline
status, groups stratified by history of pre-existing psychiatric disorder.
Objectives. To develop the Safety, Meaning, Activation and Resilience Training (SMART)
protocol; To evaluate its short and long-term effectiveness, relative to viable placebo,
Supportive Counseling (SC), in improving key dependent measures (e.g., ASD, PTSD),
mediators, and, enhancing health and function outcomes.
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
management, and treatment with prolonged exposure and cognitive restructuring) 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).
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