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

Overview

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)
  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
• Behavioral minimally Enhanced Usual Care control (mEUC)
  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 comple

Primary outcome measures

• Social Constraints Scale [Time frame: Before treatment, immediately after ending treatment, 6-week follow-up]
• Feasibility of Recruitment [Time frame: baseline]
• Feasibility of Data Collection [Time frame: From enrollment to the end of study assessments at 6-weeks posttreament]
• Acceptability: Satisfaction with Treatment [Time frame: Immediately after ending treatment]
• Acceptabilitly: Retention [Time frame: Immediately after ending treatment]
• Acceptability: Global Improvement Rating [Time frame: Immediately after ending treatment]

Secondary outcome measures (6)

• PTSD Checklist for DSM-5 (PCL-5) [Time frame: Pretreatment, Immediately after ending treatment, 6-week follow-up]
• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [Time frame: Immediately after ending treatment, 6-week follow-up]
• Hospital Anxiety and Depression Scale (HADS) [Time frame: Pretreatment, immediately after ending treatment, 6-week follow-up]
• MINI Montreal International Neuropsychiatric Interview v. 7.0.2 (MINI) [Time frame: Pretreatment, immediately after ending treatment, 6-week follow-up]
• Dyadic Relationship Scale (DRS) [Time frame: Pretreatment, immediately after ending treatment, 6-week follow-up]
• Significant Other's Responses to Trauma Scale (SORTS) [Time frame: Pretreatment, immediately after ending treatment, 6-week follow-up]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• University of Southern California, Keck School of Medicine & Los Angeles General Medical C — Los Angeles

Identifiers

NCT: NCT07656545 · HS-25-00383 · 1K23MH141296-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗