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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Aug 1, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2028

Completion

Feb 28, 2029

Study Design

Enrollment

44 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Promotion of Emotional Disclosure for Burns (PoED-B)
  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.
• Active Comparator: minimally Enhanced Usual Care control (mEUC)
  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.

Primary Outcome Measure

Social Constraints Scale [ Time Frame: Before treatment, immediately after ending treatment, 6-week follow-up ]

Central Contacts

• Sarah Stoycos, PhD
  323-409-7621
  [email protected]

Locations (1)

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