Stress Disorders, Post-Traumatic, Mood Disorders, Sleep Disorders
Conditions
Keywords
Behavior Therapy, Randomized Controlled Trial
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALCognitive Behavioral Therapy
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.
BEHAVIORALSupportive Counseling
Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)
Sponsors
U.S. Department of Education
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 70 years old * acute burn injury * exceeding criteria on screening instrument at baseline (in-hospital prior to treatment): Acute Stress Disorder Scale (ASDS score ≥ 37: acute posttrauma distress).
Exclusion criteria
* Age less than 18 or greater than 70 years * Presence of a significant cognitive / neurological or psychiatric condition precluding informed consent (e.g., psychosis, acute suicidality) * Inability to communicate in English * intubated or sedated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Structured Clinical Interview for DSM IV: Mood and PTSD modules | 1 week, 1 month and 6 months post-treatment |
Secondary
| Measure | Time frame |
|---|---|
| Patient Health Questionnaire - 9 (depression) | 1 week, 1 month and 6 months post-treatment |
| Davidson Trauma Scale | 1 week, 1 month and 6 months post-treatment |
| Insomnia Severity Index | 1 week, 1 month and 6 months post-treatment |
| Post Traumatic Growth Inventory | 1 week, 1 month and 6 months post-treatment |
| McGill pain Questionnaire | 1 week, 1 month and 6 months post-treatment |
Countries
United States
Outcome results
None listed