Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries (SMART)

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

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.

Study Overview

• Status: Completed
• Conditions: Mood Disorders; Stress Disorders, Post-Traumatic; Sleep Disorders
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Supportive Counseling

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Burn Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: U.S. Department of Education
• Investigators: Principal Investigator: James A Fauerbach, PhD, Johns Hopkins University; Principal Investigator: Una D McCann, MD, Johns Hopkins University

Publications and helpful links

General Publications

• McKibben JB, Bresnick MG, Wiechman Askay SA, Fauerbach JA. Acute stress disorder and posttraumatic stress disorder: a prospective study of prevalence, course, and predictors in a sample with major burn injuries. J Burn Care Res. 2008 Jan-Feb;29(1):22-35. doi: 10.1097/BCR.0b013e31815f59c4.
• Fauerbach JA, McKibben J, Bienvenu OJ, Magyar-Russell G, Smith MT, Holavanahalli R, Patterson DR, Wiechman SA, Blakeney P, Lezotte D. Psychological distress after major burn injury. Psychosom Med. 2007 Jun;69(5):473-82. doi: 10.1097/psy.0b013e31806bf393.
• Smith MT, Klick B, Kozachik S, Edwards RE, Holavanahalli R, Wiechman S, Blakeney P, Lezotte D, Fauerbach JA. Sleep onset insomnia symptoms during hospitalization for major burn injury predict chronic pain. Pain. 2008 Sep 15;138(3):497-506. doi: 10.1016/j.pain.2008.01.028. Epub 2008 Mar 24.
• Edwards RR, Magyar-Russell G, Thombs B, Smith MT, Holavanahalli RK, Patterson DR, Blakeney P, Lezotte DC, Haythornthwaite JA, Fauerbach JA. Acute pain at discharge from hospitalization is a prospective predictor of long-term suicidal ideation after burn injury. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S36-42. doi: 10.1016/j.apmr.2007.05.031.
• Edwards RR, Smith MT, Klick B, Magyar-Russell G, Haythornthwaite JA, Holavanahalli R, Patterson DR, Blakeney P, Lezotte D, McKibben J, Fauerbach JA. Symptoms of depression and anxiety as unique predictors of pain-related outcomes following burn injury. Ann Behav Med. 2007 Nov-Dec;34(3):313-22. doi: 10.1007/BF02874556.
• Esselman PC, Thombs BD, Magyar-Russell G, Fauerbach JA. Burn rehabilitation: state of the science. Am J Phys Med Rehabil. 2006 Apr;85(4):383-413. doi: 10.1097/01.phm.0000202095.51037.a3. No abstract available.
• Fauerbach JA, Lezotte D, Hills RA, Cromes GF, Kowalske K, de Lateur BJ, Goodwin CW, Blakeney P, Herndon DN, Wiechman SA, Engrav LH, Patterson DR. Burden of burn: a norm-based inquiry into the influence of burn size and distress on recovery of physical and psychosocial function. J Burn Care Rehabil. 2005 Jan-Feb;26(1):21-32. doi: 10.1097/01.bcr.0000150216.87940.ac.
• Lawrence JW, Fauerbach JA. Personality, coping, chronic stress, social support and PTSD symptoms among adult burn survivors: a path analysis. J Burn Care Rehabil. 2003 Jan-Feb;24(1):63-72; discussion 62. doi: 10.1097/00004630-200301000-00016.
• Fauerbach JA, Richter L, Lawrence JW. Regulating acute posttrauma distress. J Burn Care Rehabil. 2002 Jul-Aug;23(4):249-57. doi: 10.1097/00004630-200207000-00005.
• Fauerbach JA, Lawrence JW, Fogel J, Richter L, Magyar-Russell G, McKibben JB, McCann U. Approach-avoidance coping conflict in a sample of burn patients at risk for posttraumatic stress disorder. Depress Anxiety. 2009;26(9):838-50. doi: 10.1002/da.20439.

Helpful Links

• Johns Hopkins Burn Center

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2007
• Primary Completion (Actual): October 15, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 30, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (Estimate): October 1, 2009

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Behavior Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Disease; Sleep Wake Disorders; Stress Disorders, Post-Traumatic; Mood Disorders
• Other Study ID Numbers: NA_00002545; NIDRR H133A070045; H133A070045 (Other Grant/Funding Number: NIDILRR)