Acute Stress Disorder, Burns, Posttraumatic Stress Disorder, Relationship, Social, Stress Disorder, Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Stress Disorders, Traumatic, Acute, Trauma and Stressor Related Disorders, Trauma and Stress Related Disorders, Traumatic Injury
Conditions
Brief 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.
Interventions
BEHAVIORALPromotion 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 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.
BEHAVIORALminimally 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 completion, participants will be given referrals for outpatient mental health services.
Sponsors
University of Southern California
Los Angeles General Medical Center
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Constraints Scale | Before treatment, immediately after ending treatment, 6-week follow-up | 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. |
| Feasibility of Recruitment | baseline | Proportion of participants who agree to participate from the total number of those that are eligible and approached. |
| Feasibility of Data Collection | From enrollment to the end of study assessments at 6-weeks posttreament | Proportion of participants who completed each and all assessment timepoints |
| Acceptability: Satisfaction with Treatment | Immediately after ending 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. |
| Acceptabilitly: Retention | Immediately after ending treatment | Proportion of enrolled dyads who completed at least 3 out of 4 PoED sessions. |
| Acceptability: Global Improvement Rating | Immediately after ending treatment | Proportion of participants who report overall improvement on the Global Rating of Change Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | Pretreatment, Immediately after ending treatment, 6-week follow-up | 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. |
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Immediately after ending treatment, 6-week follow-up | 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. |
| Hospital Anxiety and Depression Scale (HADS) | Pretreatment, immediately after ending treatment, 6-week follow-up | 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. |
| MINI Montreal International Neuropsychiatric Interview v. 7.0.2 (MINI) | Pretreatment, immediately after ending treatment, 6-week follow-up | The MINI is a brief (\~15 minutes) structured psychodiagnostic interview for assessing DSM-5 disorders. |
| Dyadic Relationship Scale (DRS) | Pretreatment, immediately after ending treatment, 6-week follow-up | The Dyadic Relationship Scale is a self-report survey measuring dyadic strain and positive dyadic interaction specific to patient's health. There is a 10-item patient-version and 11-item caregiver version. Dyadic strain subscale scores range from 0-12 (patient version) and 0-15 (caregiver version). Positive dyadic interaction subscale scores range from 0-18. Higher scores on each of these scales indicate higher levels of strain and positive interaction, respectively. |
| Significant Other's Responses to Trauma Scale (SORTS) | Pretreatment, immediately after ending treatment, 6-week follow-up | The Significant Other's Responses to Trauma Scale is a 14-item self-report measure assessing frequency \& intensity of caregiver PTSD accommodation behaviors. Total scores can range from 0-112 with higher scores indicating greater accommodation. |
Countries
United States
Contacts
CONTACTSarah Stoycos, PhD
PRINCIPAL_INVESTIGATORSarah Stoycos, PhD
University of Southern California, Keck School of Medicine
Outcome results
None listed