The purpose of this study is to determine whether a newly developed, brief cognitive behavioral intervention, relative to supportive counseling, is effective in reducing acute stress disorder (ASD) and preventing post traumatic stress disorder (PTSD) and depression.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
CBT (4 sessions): 1) Cognitive therapy targeting key appraisals. 2) Prolonged exposure targeting trauma memories and reminders. 3) Active coping/Anxiety Management training mindfulness-based techniques.
Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)
Johns Hopkins Burn Center
Baltimore, Maryland, United States
Structured Clinical Interview for DSM IV: Mood and PTSD modules
Time frame: 1 week, 1 month and 6 months post-treatment
Davidson Trauma Scale
Time frame: 1 week, 1 month and 6 months post-treatment
Patient Health Questionnaire - 9 (depression)
Time frame: 1 week, 1 month and 6 months post-treatment
Insomnia Severity Index
Time frame: 1 week, 1 month and 6 months post-treatment
Post Traumatic Growth Inventory
Time frame: 1 week, 1 month and 6 months post-treatment
McGill pain Questionnaire
Time frame: 1 week, 1 month and 6 months post-treatment
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