Clinical Trials Logo
  1. Home
  2. Stress Disorders, Post-Traumatic
  3. NCT00988104

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

Stress Disorders, Post-Traumatic Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00988104
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase N/A
Start date October 16, 2007
Completion date December 2015
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05620381 - Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018
Completed NCT02856412 - Improving Mind/Body Health and Functioning With Integrative Exercise N/A
Recruiting NCT05400200 - PTSD and Self-regulation: Coping, Emotional Regulation and Cognitive Control and Their Relationships to Symptom Management N/A
Not yet recruiting NCT06088303 - Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication N/A
Not yet recruiting NCT03652922 - Propranolol Reactivation Mismatch (PRM) Treatment for PTSD Phase 4
Completed NCT02875912 - Prospective Evaluation of Family Care Rituals in the ICU N/A
Completed NCT01589575 - Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives N/A
Completed NCT01291368 - Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care N/A
Completed NCT00990106 - Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD) N/A
Active, not recruiting NCT00657787 - Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans
Completed NCT00835627 - Treatment Trial for Psychogenic Nonepileptic Seizures Phase 4
Completed NCT00880152 - Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study N/A
Completed NCT01365247 - Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00419029 - Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment N/A
Completed NCT00514956 - Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT00333710 - Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD N/A
Completed NCT01120847 - Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
Completed NCT00069225 - Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder N/A
Completed NCT00055354 - Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00186212 - Alternative Support for Rural and Isolated Women in an HMO Phase 3