Health TrialsbyHealthPanel

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

ConditionsPosttraumatic Stress DisorderBurnsTraumatic InjuryAcute Stress DisorderTrauma and Stressor Related DisordersTrauma and Stress Related DisordersStress DisorderStress Disorders, Post-TraumaticStress Disorders, TraumaticStress Disorders, Traumatic, AcuteRelationship, Social
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Promotion of Emotional Disclosure for Burns (PoED-B)Experimental treatment 1 intervention
Group B: minimally Enhanced Usual Care control (mEUC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Before treatment, immediately after ending treatment, 6-week follow-up
2

Feasibility of Recruitment

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

Time frame
baseline
3

Feasibility of Data Collection

Proportion of participants who completed each and all assessment timepoints

Time frame
From enrollment to the end of study assessments at 6-weeks posttreament
4

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.

Time frame
Immediately after ending treatment

Secondary outcomes

1

PTSD Checklist for DSM-5 (PCL-5)

The PTSD Checklist for DSM-5 is a 20 item self-report measure assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.

Time frame
Pretreatment, Immediately after ending treatment, 6-week follow-up
2

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

The Clinician-Administered PTSD Scale for DSM-5 is a structured interview measure of PTSD symptom severity (frequency and intensity) in the past month. Scores can range from 0-80, with higher scores indicating worse symptom severity. Only burn patients will complete this measure, not caregivers.

Time frame
Immediately after ending treatment, 6-week follow-up
3

Hospital Anxiety and Depression Scale (HADS)

The Hospital Anxiety and Depression Scale is a 14-item self-report measure of anxiety and depression symptoms that was designed for the hospital environment. Each subscale has 7-items answered on a 4-point scale ranging from 0 to 3, yielding a maximum possible score of 21 for each subscale. Higher scores indicate worse symptoms.

Time frame
Pretreatment, immediately after ending treatment, 6-week follow-up
4

MINI Montreal International Neuropsychiatric Interview v. 7.0.2 (MINI)

The MINI is a brief (\~15 minutes) structured psychodiagnostic interview for assessing DSM-5 disorders.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

Los Angeles General Medical Center

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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