Johns Hopkins Burn Center
Baltimore, Maryland, 21224, United States
NCT Number: NCT00988104
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21224, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)
Other names: Usual Care
Time frame: 1 week, 1 month and 6 months post-treatment
Time frame: 1 week, 1 month and 6 months post-treatment
Time frame: 1 week, 1 month and 6 months post-treatment
Time frame: 1 week, 1 month and 6 months post-treatment
Time frame: 1 week, 1 month and 6 months post-treatment
Time frame: 1 week, 1 month and 6 months post-treatment
Johns Hopkins University
Other
Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries: the Safety, Meaning, Activation and Resilience Trial (SMART)
Acronym: SMART
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04395157
Anxiety Disorders, Generalized Anxiety Disorder
San Diego, California, United States
View Trial DetailsNCT03969589
Mental Disorders, Mood Disorders
Baltimore, Maryland, United States
View Trial DetailsNCT00990106
Combat Disorders, Mental Disorders
Seattle, Washington, United States
View Trial DetailsNCT00261729
Mental Disorders, Nervous System Diseases
Seattle, Washington, United States
View Trial Details