This trial is active, not recruiting.

Conditions stress disorders, post-traumatic, mood disorders, sleep disorders
Treatments cognitive behavioral therapy, supportive counseling
Phase phase 3
Sponsor Johns Hopkins University
Collaborator U.S. Department of Education
Start date October 2007
End date August 2016
Trial size 130 participants
Trial identifier NCT00988104, H133A070045, NIDRR H133A070045


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
(Active Comparator)
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
Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)

Primary Outcomes

Structured Clinical Interview for DSM IV: Mood and PTSD modules
time frame: 1 week, 1 month and 6 months post-treatment

Secondary Outcomes

Davidson Trauma Scale
time frame: 1 week, 1 month and 6 months post-treatment
Patient Health Questionnaire - 9 (depression)
time frame: 1 week, 1 month and 6 months post-treatment
Insomnia Severity Index
time frame: 1 week, 1 month and 6 months post-treatment
Post Traumatic Growth Inventory
time frame: 1 week, 1 month and 6 months post-treatment
McGill pain Questionnaire
time frame: 1 week, 1 month and 6 months post-treatment

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Safety, Meaning, Activation and Resilience Trial (SMART)
Principal investigator James A Fauerbach, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins University.