Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers
14 июня 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
- Бернс
- Стрессовые расстройства, травматические
- Стрессовые расстройства, посттравматические
- Расстройства, связанные с травмой и стрессом
- Пост-травматическое стрессовое растройство
- Стрессовое расстройство
- Стрессовые расстройства, травматические, острые
- Острое стрессовое расстройство
- Расстройства, связанные с травмой и стрессом
- Отношения, Социальные
- Травматическая травма
Тип исследования
Интервенционный
Регистрация (Оцененный)
44
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Sarah Stoycos, PhD
- Номер телефона: 323-409-7621
- Электронная почта: sarah.stoycos@med.usc.edu
Места учебы
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California
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Los Angeles, California, Соединенные Штаты, 90033
- University of Southern California, Keck School of Medicine & Los Angeles General Medical Center
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Контакт:
- Sarah Stoycos, PhD
- Номер телефона: 323-409-7621
- Электронная почта: sarah.stoycos@med.usc.edu
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Social Constraints Scale
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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PTSD Checklist for DSM-5 (PCL-5)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Sarah Stoycos, PhD, University of Southern California, Keck School of Medicine
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 августа 2026 г.
Первичное завершение (Оцененный)
31 декабря 2028 г.
Завершение исследования (Оцененный)
28 февраля 2029 г.
Даты регистрации исследования
Первый отправленный
3 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
14 июня 2026 г.
Первый опубликованный (Действительный)
18 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
14 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HS-25-00383
- 1K23MH141296-01 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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.
Сроки обмена 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.
Критерии совместного доступа к 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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .