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

NCT07656545 | Not Yet Recruiting DMC

• 2 other identifiers: HS-25-003831K23MH141296-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder; Burns; Traumatic Injury; Acute Stress Disorder; Trauma and Stressor Related Disorders; Trauma and Stress Related Disorders; Stress Disorder; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Stress Disorders, Traumatic, Acute; Relationship, Social

Outcome Measures

Primary Outcomes (6)

• Social Constraints Scale

  The Social Constraints Scale is a self-report scale administered to both the patient and caregiver. It is designed to assess perceptions of negative reactions to trauma-disclosures. The scale contains 15 items, and each item is scored on a four-point scale ranging from 1 (never) to 4 (often) with total scores ranging from 15 to 60. A higher score indicates a higher frequency of experiencing social constraints.

  Before treatment, immediately after ending treatment, 6-week follow-up

• Feasibility of Recruitment

  Proportion of participants who agree to participate from the total number of those that are eligible and approached.

  baseline

• Feasibility of Data Collection

  Proportion of participants who completed each and all assessment timepoints

  From enrollment to the end of study assessments at 6-weeks posttreament

• Acceptability: Satisfaction with Treatment

  Client Satisfaction Questionnaire (CSQ) - Self-Report - The CSQ has 8 items assessing client satisfaction with the treatment they have received. Total scores range from 8-32; higher scores indicate greater client satisfaction/treatment acceptability. This measure will be completed by both patients and their loved ones.

  Immediately after ending treatment

• Acceptabilitly: Retention

  Proportion of enrolled dyads who completed at least 3 out of 4 PoED sessions.

  Immediately after ending treatment

• Acceptability: Global Improvement Rating

  Proportion of participants who report overall improvement on the Global Rating of Change Scale

  Immediately after ending treatment

Secondary Outcomes (6)

• PTSD Checklist for DSM-5 (PCL-5)

  Pretreatment, Immediately after ending treatment, 6-week follow-up

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  Immediately after ending treatment, 6-week follow-up

• Hospital Anxiety and Depression Scale (HADS)

  Pretreatment, immediately after ending treatment, 6-week follow-up

• MINI Montreal International Neuropsychiatric Interview v. 7.0.2 (MINI)

  Pretreatment, immediately after ending treatment, 6-week follow-up

• Dyadic Relationship Scale (DRS)

  Pretreatment, immediately after ending treatment, 6-week follow-up

Study Arms (2)

Promotion of Emotional Disclosure for Burns (PoED-B)

EXPERIMENTAL

Participants randomized into this arm will receive Promotion of Emotional Disclosure for Burns (PoED-B), a cognitive behavioral therapy intervention designed for burn survivors and a loved one of their choosing to complete together. The standard treatment length will be 4 sessions, however participants and providers may agree to additional sessions as warranted.

Behavioral: Promotion of Emotional Disclosure for Burns (PoED-B)

minimally Enhanced Usual Care control (mEUC)

ACTIVE COMPARATOR

Participants randomized into this arm will receive a minimally enhanced version of usual burn care. This will include one, 30-minute supportive therapy session focused on psychoeducation about the potential psychological impact of burn injury and hospitalization and referral to outpatient resources, if wanted.

Behavioral: minimally Enhanced Usual Care control (mEUC)

Interventions

Promotion of Emotional Disclosure for Burns (PoED-B) BEHAVIORAL

PoED-B is a dyadic treatment where both patient and identified informal caregiver participate. PoED-B targets reducing disclosure-constraining behaviors (e.g., invalidating, negative statements) using psychoeducation, motivational interviewing, and skills training. The goal is to encourage the patient-caregiver dyad to engage in natural disclosures, supportive responses, and approach coping after the burn trauma to facilitate emotional processing. It is four sessions long. Delivery format takes into account stakeholder feedback, considering overall burden during acute hospitalization and the transition to outpatient care. Sessions one and two are 30 minutes and one week apart. Sessions three and four are 50 minutes long and two weeks apart. Session one must occur during hospitalization. Sessions 2-4 can be completed via video/telehealth if the patient is discharged during the treatment course.

Promotion of Emotional Disclosure for Burns (PoED-B)

minimally Enhanced Usual Care control (mEUC) BEHAVIORAL

mEUC is an individually-administered psychoeducation control for burn patients modeled after minimally enhanced care in acute care surgery units. In one 30-minute session, the therapist reviews with the participant a standardized psychoeducation handout on common psychological reactions after burn injury, giving them time to ask questions or express concerns within a supportive therapy framework. Then, the participant is given the handout, which also includes self-help skills. After study completion, participants will be given referrals for outpatient mental health services.

minimally Enhanced Usual Care control (mEUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alert, oriented, \& not withdrawing from substance at time of screening
• Can read and write in English
• Hospitalized within 10 days of burn injury
• Anticipated discharge \<=4 weeks
• Have an email, mailing address, and at least 1 smart device for telehealth sessions
• PTSD risk score of 2 or greater (patient-only)
• Willing to attend therapy sessions with a loved one

You may not qualify if:

• Currently incarcerated or in police custody
• \> 10 days post-burn
• Lifetime diagnosis of primary psychosis or intellectual disability
• Ongoing reported domestic violence in the dyad
• Unstable bipolar disorder, severe substance use disorder, or acute suicidality with imminent intent that does not remit within 10 days of burn-injury
• Inflammation Confounds (patient-only) of BMI \> 40, metabolic syndrome, admission A1C of \>= 6.5%
• Currently receiving couples therapy

Sponsors & Collaborators

• University of Southern California: lead
• Los Angeles General Medical Center: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Southern California, Keck School of Medicine & Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Burns; Wounds and Injuries; Stress Disorders, Traumatic, Acute; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sarah Stoycos, PhD

  University of Southern California, Keck School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Stoycos, PhD

CONTACT

323-409-7621; sarah.stoycos@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 18, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be deposited starting 18 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates. Data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data is controlled by the NDA; NDA currently has no process for deleting or retiring datasets, and thus far no data has been removed to our knowledge.
• Access Criteria: To request access to the data, researchers can use the standard processes at NDA; the NDA Data Access Committee will review requests and decide which requests to grant. The standard NDA access process allows access for one year and is renewable thereafter.

Locations

US (1)