Reducing PTSD in Hospitalized Burn Patients
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Treatment for Acutely Burned Patients (BTBP)
Sponsored by
About this trial
This is an interventional prevention trial for Posttraumatic Stress Disorder focused on measuring Stress Disorders, Post-Traumatic, Burns, Brief Psychotherapy, Cognitive Behavior Therapy
Eligibility Criteria
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
Sites / Locations
- LAC+USC Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Brief Treatment for Acutely Burned Patients (BTBP)
Outcomes
Primary Outcome Measures
Change from baseline on Posttraumatic Stress-Total (PTS-T) scale of Detailed Assessment of Posttraumatic Stress (DAPS)
Secondary Outcome Measures
Change from baseline on Beck Depression Inventory
Full Information
NCT ID
NCT02026037
First Posted
December 31, 2013
Last Updated
September 19, 2017
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT02026037
Brief Title
Reducing PTSD in Hospitalized Burn Patients
Official Title
A Brief Intervention to Reduce PTSD in Acutely Burned Hospital Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Stress Disorders, Post-Traumatic, Burns, Brief Psychotherapy, Cognitive Behavior Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Brief Treatment for Acutely Burned Patients (BTBP)
Intervention Type
Behavioral
Intervention Name(s)
Brief Treatment for Acutely Burned Patients (BTBP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline on Posttraumatic Stress-Total (PTS-T) scale of Detailed Assessment of Posttraumatic Stress (DAPS)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline on Beck Depression Inventory
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline on Beck Anxiety Inventory
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Briere, Ph.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Warren Garner, M.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Randye J. Semple, Ph.D.
Organizational Affiliation
University of Southern California
Official's Role
Study Director
Facility Information:
Facility Name
LAC+USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reducing PTSD in Hospitalized Burn Patients
We'll reach out to this number within 24 hrs