Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries (SMART)
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|ClinicalTrials.gov Identifier: NCT00988104|
Recruitment Status : Active, not recruiting
First Posted : October 1, 2009
Last Update Posted : January 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic Mood Disorders Sleep Disorders||Behavioral: Cognitive Behavioral Therapy Behavioral: Supportive Counseling||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries: the Safety, Meaning, Activation and Resilience Trial (SMART)|
|Actual Study Start Date :||October 16, 2007|
|Estimated Primary Completion Date :||October 15, 2018|
|Estimated Study Completion Date :||December 2018|
|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 Name: SMART
|Active Comparator: Supportive Counseling||
Behavioral: Supportive Counseling
Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)
Other Name: Usual Care
- Structured Clinical Interview for DSM IV: Mood and PTSD modules [ Time Frame: 1 week, 1 month and 6 months post-treatment ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988104
|United States, Maryland|
|Johns Hopkins Burn Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||James A Fauerbach, PhD||Johns Hopkins University|
|Principal Investigator:||Una D McCann, MD||Johns Hopkins University|