Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries

Study Overview
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Brief Summary
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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
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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).

Official Title
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Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries: the Safety, Meaning, Activation and Resilience Trial (SMART)

Conditions
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Stress Disorders, Post-Traumatic, Mood Disorders, Sleep Disorders

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Supportive Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Behavioral Therapy<br> | Behavioral: Cognitive Behavioral Therapy<br>* 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.<br>* Other names: SMART;|
| Active Comparator: Supportive Counseling<br> | Behavioral: Supportive Counseling<br>* Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)<br>* Other names: Usual Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structured Clinical Interview for DSM IV: Mood and PTSD modules |  | 1 week, 1 month and 6 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Davidson Trauma Scale |  | 1 week, 1 month and 6 months post-treatment | 
| Patient Health Questionnaire - 9 (depression) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior Therapy, Randomized Controlled Trial