Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic; Mood Disorders; Sleep Disorders
• Interventions: Behavioral: Supportive Counseling; Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT00988104
• Lead Sponsor: Johns Hopkins University

Brief 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.

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).

Study Timeline

• Study Start: 2007-10-16
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2015-10-15
• Study Completion: 2015-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18 to 70 years old
• acute burn injury
• exceeding criteria on screening instrument at baseline (in-hospital prior to treatment): Acute Stress Disorder Scale (ASDS score ≥ 37: acute posttrauma distress).

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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
• intubated or sedated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive Counseling	Supportive Counseling	-
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Burn Center; 🇺🇸 Baltimore, Maryland, United States