Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries (SMART)
Recruitment status was Recruiting
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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 |
- 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 ]
- 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: | September 2012 |
| Estimated Primary Completion Date: | March 2012 (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 |
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 significant a cognitive / neurological or psychiatric condition precluding informed consent (e.g., psychosis, acute suicidality)
- Inability to communicate in English
Contacts and Locations| Contact: Lauren Allen, BS | 410.550.9846 | lallen1@jhmi.edu |
| Contact: James A Fauerbach, PhD | 410.550.0894 | jfauerb1@jhmi.edu |
| United States, Maryland | |
| Johns Hopkins Burn Center | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Suzette Morgan 410-955-1567 | |
| Sub-Investigator: Michael Smith, PhD | |
| 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: | Suzette F. Morgan, Johns Hopkins School of Medicine, Office of Research Administration |
| ClinicalTrials.gov Identifier: | NCT00988104 History of Changes |
| Other Study ID Numbers: | H133A070045, NIDRR H133A070045 |
| Study First Received: | September 30, 2009 |
| Last Updated: | September 30, 2009 |
| 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 May 16, 2013