Posttraumatic Stress DisorderNCT02026037
Reducing PTSD in Hospitalized Burn Patients
A study testing Brief Treatment for Acutely Burned Patients (BTBP) in people with Posttraumatic Stress Disorder, run by University of Southern California at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Brief Treatment for Acutely Burned Patients (BTBP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC+USC Medical Center
Los Angeles, California, 90033
About this study
Official title: A Brief Intervention to Reduce PTSD in Acutely Burned Hospital Patients
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
- Being tested
- Brief Treatment for Acutely Burned Patients (BTBP)
- Keywords
- Stress Disorders, Post-Traumatic, Burns, Brief Psychotherapy, Cognitive Behavior Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Treatment for Acutely Burned Patients (BTBP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Brief Treatment for Acutely Burned Patients (BTBP) Receives: Behavioral: Brief Treatment for Acutely Burned Patients (BTBP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on Posttraumatic Stress-Total (PTS-T) scale of Detailed Assessment of Posttraumatic Stress (DAPS)
Measured: 6 weeks
Secondary outcomes (1)
Change from baseline on Beck Depression Inventory
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Briere, University of Southern California
- Investigators
- John Briere, Ph.D., Principal investigator, University of Southern CaliforniaWarren Garner, M.D., Principal investigator, University of Southern CaliforniaRandye J. Semple, Ph.D., Study director, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026037
- Sponsor's protocol ID
- CTSI 21-2716-3128
- Status last verified
- Sep 2017
- First submitted
- 31 Dec 2013
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention to Reduce PTSD in Acutely Burned Hospital Patients
- ClinicalTrials.gov ID
- NCT02026037
- Acronym / sponsor ID
- CTSI 21-2716-3128
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Stress Disorders, Post-Traumatic, Burns, Brief Psychotherapy, Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Brief Treatment for Acutely Burned Patients (BTBP)Brief Treatment for Acutely Burned Patients (BTBP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Experimental |
Primary outcome
Change from baseline on Posttraumatic Stress-Total (PTS-T) scale of Detailed Assessment of Posttraumatic Stress (DAPS)
Time frame: 6 weeks
1 secondary outcome
Change from baseline on Beck Depression Inventory
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Briere, Ph.D. principal investigator
University of Southern California
Warren Garner, M.D. principal investigator
University of Southern California
Randye J. Semple, Ph.D. study director
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Treatment for Acutely Burned Patients (BTBP) in people with Posttraumatic Stress Disorder, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on Posttraumatic Stress-Total (PTS-T) scale of Detailed Assessment of Posttraumatic Stress (DAPS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.