Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers
14 de junio de 2026 actualizado por: University of Southern California
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
- Quemaduras
- Trastornos de Estrés, Traumáticos
- Trastornos de estrés postraumático
- Trastornos relacionados con el trauma y el estrés
- Trastorno de estrés postraumático
- Trastorno de estrés
- Trastornos De Estrés, Traumático, Agudo
- Trastorno de estrés agudo
- Trastornos relacionados con el trauma y el estrés
- Relaciones Sociales
- Lesión traumática
Tipo de estudio
Intervencionista
Inscripción (Estimado)
44
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Sarah Stoycos, PhD
- Número de teléfono: 323-409-7621
- Correo electrónico: sarah.stoycos@med.usc.edu
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90033
- University of Southern California, Keck School of Medicine & Los Angeles General Medical Center
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Contacto:
- Sarah Stoycos, PhD
- Número de teléfono: 323-409-7621
- Correo electrónico: sarah.stoycos@med.usc.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Promotion of Emotional Disclosure for Burns (PoED-B)
Participants randomized into this arm will receive Promotion of Emotional Disclosure for Burns (PoED-B), a cognitive behavioral therapy intervention designed for burn survivors and a loved one of their choosing to complete together.
The standard treatment length will be 4 sessions, however participants and providers may agree to additional sessions as warranted.
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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.
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Comparador activo: minimally Enhanced Usual Care control (mEUC)
Participants randomized into this arm will receive a minimally enhanced version of usual burn care.
This will include one, 30-minute supportive therapy session focused on psychoeducation about the potential psychological impact of burn injury and hospitalization and referral to outpatient resources, if wanted.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Social Constraints Scale
Periodo de tiempo: Before treatment, immediately after ending treatment, 6-week follow-up
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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.
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Before treatment, immediately after ending treatment, 6-week follow-up
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Feasibility of Recruitment
Periodo de tiempo: baseline
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Proportion of participants who agree to participate from the total number of those that are eligible and approached.
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baseline
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Feasibility of Data Collection
Periodo de tiempo: From enrollment to the end of study assessments at 6-weeks posttreament
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Proportion of participants who completed each and all assessment timepoints
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From enrollment to the end of study assessments at 6-weeks posttreament
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Acceptability: Satisfaction with Treatment
Periodo de tiempo: Immediately after ending treatment
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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.
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Immediately after ending treatment
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Acceptabilitly: Retention
Periodo de tiempo: Immediately after ending treatment
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Proportion of enrolled dyads who completed at least 3 out of 4 PoED sessions.
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Immediately after ending treatment
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Acceptability: Global Improvement Rating
Periodo de tiempo: Immediately after ending treatment
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Proportion of participants who report overall improvement on the Global Rating of Change Scale
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Immediately after ending treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PTSD Checklist for DSM-5 (PCL-5)
Periodo de tiempo: Pretreatment, Immediately after ending treatment, 6-week follow-up
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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.
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Pretreatment, Immediately after ending treatment, 6-week follow-up
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Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Periodo de tiempo: Immediately after ending treatment, 6-week follow-up
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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.
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Immediately after ending treatment, 6-week follow-up
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Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: Pretreatment, immediately after ending treatment, 6-week follow-up
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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.
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Pretreatment, immediately after ending treatment, 6-week follow-up
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MINI Montreal International Neuropsychiatric Interview v. 7.0.2 (MINI)
Periodo de tiempo: Pretreatment, immediately after ending treatment, 6-week follow-up
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The MINI is a brief (~15 minutes) structured psychodiagnostic interview for assessing DSM-5 disorders.
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Pretreatment, immediately after ending treatment, 6-week follow-up
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Dyadic Relationship Scale (DRS)
Periodo de tiempo: Pretreatment, immediately after ending treatment, 6-week follow-up
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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.
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Pretreatment, immediately after ending treatment, 6-week follow-up
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Significant Other's Responses to Trauma Scale (SORTS)
Periodo de tiempo: Pretreatment, immediately after ending treatment, 6-week follow-up
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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.
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Pretreatment, immediately after ending treatment, 6-week follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sarah Stoycos, PhD, University of Southern California, Keck School of Medicine
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
31 de diciembre de 2028
Finalización del estudio (Estimado)
28 de febrero de 2029
Fechas de registro del estudio
Enviado por primera vez
3 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de junio de 2026
Publicado por primera vez (Actual)
18 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HS-25-00383
- 1K23MH141296-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified demographic and raw quantitative data will be deposited into the NIMH Data Archive (NDA).
All data will be de-identified prior to receipt by the repository.
Data will be de-identified pursuant to the HIPAA Privacy Rule, 45 CFR § 164.514(b).
A brief study protocol will also be submitted to NDA and will be made freely available.
Marco de tiempo para compartir IPD
Data will be deposited starting 18 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.
Data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first.
The duration of preservation and sharing of the data is controlled by the NDA; NDA currently has no process for deleting or retiring datasets, and thus far no data has been removed to our knowledge.
Criterios de acceso compartido de IPD
To request access to the data, researchers can use the standard processes at NDA; the NDA Data Access Committee will review requests and decide which requests to grant.
The standard NDA access process allows access for one year and is renewable thereafter.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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