Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
James A. Fauerbach, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00988104
First received: September 30, 2009
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Stress Disorders, Post-Traumatic
Mood Disorders
Sleep Disorders
Behavioral: Cognitive Behavioral Therapy
Behavioral: Supportive Counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety, Meaning, Activation and Resilience Trial (SMART)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Structured Clinical Interview for DSM IV: Mood and PTSD modules [ Time Frame: 1 week, 1 month and 6 months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Davidson Trauma Scale [ Time Frame: 1 week, 1 month and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire - 9 (depression) [ Time Frame: 1 week, 1 month and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Insomnia Severity Index [ Time Frame: 1 week, 1 month and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Post Traumatic Growth Inventory [ Time Frame: 1 week, 1 month and 6 months post-treatment ] [ Designated as safety issue: No ]
  • McGill pain Questionnaire [ Time Frame: 1 week, 1 month and 6 months post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: October 2007
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: Supportive Counseling Behavioral: Supportive Counseling
Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 70 years old
  • acute major 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988104

Locations
United States, Maryland
Johns Hopkins Burn Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
U.S. Department of Education
Investigators
Principal Investigator: James A Fauerbach, PhD Johns Hopkins University
Principal Investigator: Una D McCann, MD Johns Hopkins University
  More Information

Additional Information:
Publications:

Responsible Party: James A. Fauerbach, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00988104     History of Changes
Other Study ID Numbers: H133A070045, NIDRR H133A070045
Study First Received: September 30, 2009
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Behavior Therapy
Randomized Controlled Trial

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on August 21, 2014