Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers
14. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
- Popáleniny
- Stresové poruchy, traumatické
- Stresové poruchy, posttraumatické
- Trauma a poruchy související se stresem
- Posttraumatická stresová porucha
- Stresová porucha
- Stresové poruchy, traumatické, akutní
- Akutní stresová porucha
- Trauma a poruchy související se stresem
- Vztah, Sociální
- Traumatické zranění
Typ studie
Intervenční
Zápis (Odhadovaný)
44
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Sarah Stoycos, PhD
- Telefonní číslo: 323-409-7621
- E-mail: sarah.stoycos@med.usc.edu
Studijní místa
-
-
California
-
Los Angeles, California, Spojené státy, 90033
- University of Southern California, Keck School of Medicine & Los Angeles General Medical Center
-
Kontakt:
- Sarah Stoycos, PhD
- Telefonní číslo: 323-409-7621
- E-mail: sarah.stoycos@med.usc.edu
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Aktivní komparátor: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Social Constraints Scale
Časové okno: 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
Časové okno: baseline
|
Proportion of participants who agree to participate from the total number of those that are eligible and approached.
|
baseline
|
|
Feasibility of Data Collection
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Immediately after ending treatment
|
Proportion of participants who report overall improvement on the Global Rating of Change Scale
|
Immediately after ending treatment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Sarah Stoycos, PhD, University of Southern California, Keck School of Medicine
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
31. prosince 2028
Dokončení studie (Odhadovaný)
28. února 2029
Termíny zápisu do studia
První předloženo
3. června 2026
První předloženo, které splnilo kritéria kontroly kvality
14. června 2026
První zveřejněno (Aktuální)
18. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HS-25-00383
- 1K23MH141296-01 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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.
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .