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NCT07656545 · ClinicalTrials.gov registry record · NA

Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers

A NA study, sponsored by University of Southern California.

Not yet
Registry status
NA
Development phase
44
Enrollment target

NCT07656545 is a NA study that has not yet begun recruiting, run by University of Southern California. The registered enrollment target is 44 participants.

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The verdict

NCT07656545, a NA study, has not yet begun recruiting, sponsored by University of Southern California.

NOT YET RECRUITING
Registry status
NA
Development phase
44 participants
Enrollment target

Study Summary

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.

Interventions

  • BEHAVIORAL Promotion of Emotional Disclosure for Burns (PoED-B)
  • BEHAVIORAL minimally Enhanced Usual Care control (mEUC)

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2026-08-01
Est. Completion 2029-02-28
Phase NA

Sponsor

University of Southern California

617 total trials

What the Registry Record Tells You About NCT07656545

The ClinicalTrials.gov registry entry for NCT07656545 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Promotion of Emotional Disclosure for Burns (PoED-B) is the first listed.

NCT07656545 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT07656545 about?

NCT07656545 is a clinical study titled "Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers". 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 patien...

What is the current status of trial NCT07656545?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 44 participants. The study started on 2026-08-01. Estimated completion is 2029-02-28.

What interventions are being tested in trial NCT07656545?

The interventions under investigation include: Promotion of Emotional Disclosure for Burns (PoED-B) (BEHAVIORAL), minimally Enhanced Usual Care control (mEUC) (BEHAVIORAL).

Who is sponsoring clinical trial NCT07656545?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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