Reducing PTSD in Hospitalized Burn Patients

NCT02026037 | Completed

• 1 other identifier: CTSI 21-2716-3128
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder

Keywords

Stress Disorders; Post-Traumatic; Burns; Brief Psychotherapy; Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline on Posttraumatic Stress-Total (PTS-T) scale of Detailed Assessment of Posttraumatic Stress (DAPS)

  6 weeks

Secondary Outcomes (1)

• Change from baseline on Beck Depression Inventory

  6 weeks

Other Outcomes (1)

• Change from baseline on Beck Anxiety Inventory

  6 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Brief Treatment for Acutely Burned Patients (BTBP)

Behavioral: Brief Treatment for Acutely Burned Patients (BTBP)

Interventions

Brief Treatment for Acutely Burned Patients (BTBP) BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Burns

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John Briere, Ph.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Warren Garner, M.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Randye J. Semple, Ph.D.

  University of Southern California

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Psychology

Study Record Dates

• First Submitted: December 31, 2013
• First Posted: January 1, 2014
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 21, 2017

Record last verified: 2017-09

Locations

US (1)