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

14 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

44

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • Los Angeles, California, États-Unis, 90033
        • University of Southern California, Keck School of Medicine & Los Angeles General Medical Center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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 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.
Comparateur actif: 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.
Comportemental: 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 completion, participants will be given referrals for outpatient mental health services.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Social Constraints Scale
Délai: 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.
Before treatment, immediately after ending treatment, 6-week follow-up
Feasibility of Recruitment
Délai: baseline
Proportion of participants who agree to participate from the total number of those that are eligible and approached.
baseline
Feasibility of Data Collection
Délai: From enrollment to the end of study assessments at 6-weeks posttreament
Proportion of participants who completed each and all assessment timepoints
From enrollment to the end of study assessments at 6-weeks posttreament
Acceptability: Satisfaction with Treatment
Délai: 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.
Immediately after ending treatment
Acceptabilitly: Retention
Délai: Immediately after ending treatment
Proportion of enrolled dyads who completed at least 3 out of 4 PoED sessions.
Immediately after ending treatment
Acceptability: Global Improvement Rating
Délai: Immediately after ending treatment
Proportion of participants who report overall improvement on the Global Rating of Change Scale
Immediately after ending treatment

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PTSD Checklist for DSM-5 (PCL-5)
Délai: 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.
Pretreatment, Immediately after ending treatment, 6-week follow-up
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Délai: 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.
Immediately after ending treatment, 6-week follow-up
Hospital Anxiety and Depression Scale (HADS)
Délai: 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.
Pretreatment, immediately after ending treatment, 6-week follow-up
MINI Montreal International Neuropsychiatric Interview v. 7.0.2 (MINI)
Délai: Pretreatment, immediately after ending treatment, 6-week follow-up
The MINI is a brief (~15 minutes) structured psychodiagnostic interview for assessing DSM-5 disorders.
Pretreatment, immediately after ending treatment, 6-week follow-up
Dyadic Relationship Scale (DRS)
Délai: 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.
Pretreatment, immediately after ending treatment, 6-week follow-up
Significant Other's Responses to Trauma Scale (SORTS)
Délai: 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.
Pretreatment, immediately after ending treatment, 6-week follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Southern California

Collaborateurs

National Institute of Mental Health (NIMH)
Los Angeles General Medical Center

Les enquêteurs

  • Chercheur principal: Sarah Stoycos, PhD, University of Southern California, Keck School of Medicine

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

28 février 2029

Dates d'inscription aux études

Première soumission

3 juin 2026

Première soumission répondant aux critères de contrôle qualité

14 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HS-25-00383
  • 1K23MH141296-01 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage 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.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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