Reducing PTSD in Hospitalized Burn Patients

Posttraumatic Stress Disorder Clinical Trial

Official title:

A Brief Intervention to Reduce PTSD in Acutely Burned Hospital Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026037
• Other study ID #: CTSI 21-2716-3128
• Status: Completed
• Phase: N/A
• First received: December 31, 2013
• Last updated: September 19, 2017
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose to develop and pilot-test a short-term cognitive-behavioral treatment (CBT) for hospitalized survivors of acute burns, in order to reduce posttraumatic symptoms before they consolidate into long-term posttraumatic stress disorder (PTSD). This is important because approximately one third of burn survivors develop PTSD after discharge. PTSD is associated with extended psychological suffering and a greater need for medical services in the future. Although there are treatments for chronic PTSD, there are far fewer interventions available to treat acute posttraumatic symptoms before they develop into this disorder, and none to date has focused on adult burn survivors. The little research available on other forms of trauma suggests that interventions developed to treat PTSD may be helpful in preventing PTSD when used in the first weeks following a trauma.

The investigators will develop a six-session intervention package for use with patients at the Los Angeles County + University of Southern California Burn Center. The intervention will translate CBT principles that have been validated with trauma survivors, but will be adapted to hospitalized burn patients. After manual development, we will pilot-test this treatment on 15 patients who are medically stable, and not critically ill, intubated, or delirious. Treatment will consist of three 50-minute CBT sessions per week, involving mindfulness-focused relaxation training, graduated exposure to memories of the burn, psychoeducation, and cognitive restructuring. Assessment will include standardized tests of posttraumatic stress, anxiety, and depression, administered at the initiation and termination of treatment, and at one-month follow-up. Also assessed will be number of hospital days to discharge and participant satisfaction with treatment. We will evaluate the overall feasibility of conducting a study on PTSD prevention in burn survivors, as measured by initial recruitment success, subsequent dropout rates at the end of treatment and at the one-month follow-up, and participant satisfaction. These data will then be used to support a subsequent application for funding of a larger-scale randomized clinical trial (RCT) study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male & female patients at the LAC+USC Medical Center Burn Center

• 18 years of age or older

• English-speaking, able to read & write English

• Expected by the treatment team to require at least 2 weeks of hospitalization

• Willing to participate

Exclusion Criteria:

• Patients who are critically ill; intubated; unable to converse; or delirious

• Cognitively impaired or mentally retarded

• Severely depressed or suicidal

• Psychotic; manic or hypomanic due to a bipolar affective disorder

• Currently demonstrating withdrawal from alcohol or other substances

• Patients whose physical pain level requires medications that would cognitive impair him or her to the point of diminished or impaired functioning

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Brief Treatment for Acutely Burned Patients (BTBP)
Brief Treatment for Acutely Burned Patients (BTBP) adapts CBT principles that have been validated with non-burn trauma survivors to the treatment of hospitalized burn patients. BTBP consists of three 1 to 1½ hour sessions per week for two weeks, as well as two sessions for family members or partners/spouses.

Locations

Country	Name	City	State
United States	LAC+USC Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline on Beck Anxiety Inventory		6 weeks
Primary	Change from baseline on Posttraumatic Stress-Total (PTS-T) scale of Detailed Assessment of Posttraumatic Stress (DAPS)		6 weeks
Secondary	Change from baseline on Beck Depression Inventory		6 weeks