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OpenTrials
Completed

NCT Number: NCT00988104

Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Burn Center

Baltimore, Maryland, 21224, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Behavioral

Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)

Other names: Usual Care

Primary outcomes

  1. Structured Clinical Interview for DSM IV: Mood and PTSD modules

    Time frame: 1 week, 1 month and 6 months post-treatment

Secondary outcomes

  1. Davidson Trauma Scale

    Time frame: 1 week, 1 month and 6 months post-treatment

  2. Patient Health Questionnaire - 9 (depression)

    Time frame: 1 week, 1 month and 6 months post-treatment

  3. Insomnia Severity Index

    Time frame: 1 week, 1 month and 6 months post-treatment

  4. Post Traumatic Growth Inventory

    Time frame: 1 week, 1 month and 6 months post-treatment

  5. McGill pain Questionnaire

    Time frame: 1 week, 1 month and 6 months post-treatment

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries: the Safety, Meaning, Activation and Resilience Trial (SMART)

Acronym: SMART

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2009
Registry last updated
Aug 24, 2018

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.

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