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.
Age range
18 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Social Constraints Scale
Timeframe: Before treatment, immediately after ending treatment, 6-week follow-up
Feasibility of Recruitment
Timeframe: baseline
Feasibility of Data Collection
Timeframe: From enrollment to the end of study assessments at 6-weeks posttreament
Acceptability: Satisfaction with Treatment
Timeframe: Immediately after ending treatment
Acceptabilitly: Retention
Timeframe: Immediately after ending treatment
Acceptability: Global Improvement Rating
Timeframe: Immediately after ending treatment