Emotional Disclosure Therapy for PTSD in Burn Survivors

SS
Overseen BySarah Stoycos, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Southern California
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical trial is to adapt and test a brief patient-caregiver early intervention designed to reduce posttraumatic stress symptoms in hospitalized burn patients and their caregivers. This intervention is a brief, 4-session cognitive-behavioral intervention designed for burn patients and their loved one to complete together, during and after hospitalization. The intervention targets relational communication and functioning through reduction of invalidating, negative statements and avoidant coping by teaching patients and their loved ones to engage in adaptive natural disclosures, supportive responses, and approach coping after the burn trauma. The intervention uses evidence-based psychotherapy techniques, including psychoeducation, motivational interviewing, and skills coaching. The clinical trial will occur in two sequential phases. In the first phase of the study (case series), the intervention will be provided to two burn patient-caregiver dyads (four adults) to pilot test the intervention, seek patient and provider feedback, and refine the intervention. All four adults will receive the intervention. In the second phase of the study, the randomized controlled trial (RCT) phase, investigators will enroll 20 more burn patient-caregiver dyads (40 more adults) who will be randomly assigned (like the flip of a coin) at the dyad level to receive the intervention or a burn survivor-only minimally enhanced usual care psychoeducation control condition (mEUC). The goals of the RCT phase are to study whether the intervention is acceptable to patients, feasible to conduct, and whether the intervention improves burn survivor-caregiver healthy relationship communication about difficult events and treatment outcomes compared to mEUC.

Who Is on the Research Team?

SS

Sarah Stoycos, PhD

Principal Investigator

University of Southern California, Keck School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults who are hospitalized with burn injuries and their caregivers. Both the patient and caregiver must be willing to participate together in sessions during and after hospitalization.

Inclusion Criteria

Can read and write in English
I was admitted to the hospital within 10 days after my burn injury.
Anticipated discharge less than or equal to 4 weeks
See 4 more

Exclusion Criteria

Unstable bipolar disorder, severe substance use disorder, or acute suicidality with imminent intent that does not remit within 10 days of burn-injury
Currently incarcerated or in police custody
I am more than 10 days past my burn injury.
See 4 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares a new, brief therapy (PoED-B) that helps burn survivors and their caregivers talk about emotions and cope better, versus standard care with basic education. Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Promotion of Emotional Disclosure for Burns (PoED-B)Experimental Treatment1 Intervention
Group II: minimally Enhanced Usual Care control (mEUC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

Los Angeles General Medical Center

Collaborator

Trials
1
Recruited
70+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+