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

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.

Primary Outcome

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.

Interventions

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