Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Prolonged exposure.
- Кому может быть актуально
- Состояния в реестре: PTSD, Suicidal Ideation, Suicide, Attempted, Trauma, Psychological. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.
Подробное описание
Posttraumatic stress disorder (PTSD) is associated with a host of functional problems and negative outcomes, including occupational and marital dissatisfaction, violence, alcohol and substance abuse, and suicide. Cognitive behavioral treatments tend to be the most highly efficacious treatments for PTSD. Prolonged Exposure (PE) therapy is a manualized cognitive behavioral therapy consisting of imaginal exposure followed by processing thoughts and feelings related to the imaginal experience; in-vivo exposure, psychoeducation, and controlled breathing training. Preliminary evidence suggests that PE is associated with significant suicidal ideation (SI) reductions. Enhancing PE with procedures that have been shown to significantly reduce suicidal thoughts and behaviors could serve to further reduce suicide risk during and after treatment completion.
The long-term goal of this project is to prevent suicides among individuals diagnosed with PTSD by integrating trauma-focused therapies with suicide-focused interventions. The primary objective of this pilot project is to test the efficacy of PE when enhanced with a crisis response plan utilizing self-report, behavioral, and ecological assessment methods to compare treatment effects.
Вмешательства
- Поведенческое Prolonged exposure
PE therapy is a manualized cognitive behavioral therapy consisting of imaginal exposure (repeated recounting of the most disturbing traumatic memory) followed by processing thoughts and feelings related to the imaginal experience; in-vivo exposure (approaching trauma-related situations); psychoeducation about PTSD; and controlled breathing training. Between sessions, participants listen to audio recordings of the imaginal recounting daily and complete in-vivo exercises. Typically, PE is delivere
Первичные конечные точки
- Beck Scale for Suicidal Ideation (SSI) [Срок оценки: During the first 3 weeks and through one year follow up]
- Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) [Срок оценки: During the first 3 weeks and through one year follow up]
- PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) [Срок оценки: During the first 3 weeks and through one year follow up]
Вторичные конечные точки (12)
- Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom Measure [Срок оценки: During the first 3 weeks and through one year follow up]
- Interpersonal Needs Questionnaire (INQ) - Abbreviated [Срок оценки: During the first 3 weeks and through one year follow up]
- Beck Hopelessness Scale (BHS) - Abbreviated [Срок оценки: During the first 3 weeks and through one year follow up]
- Brief Suicide Cognitions Scale (SCS) [Срок оценки: During the first 3 weeks and through one year follow up]
- Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) [Срок оценки: During the first 3 weeks and through one year follow up]
- Monetary Choice Questionnaire (MCQ) [Срок оценки: During the first 3 weeks and through one year follow up]
- Behavioral Inhibition Scale (BIS) [Срок оценки: During the first 3 weeks and through one year follow up]
- Behavioral Activation Scale (BAS) [Срок оценки: During the first 3 weeks and through one year follow up]
- Patient-Reported Outcomes Measurement Information System (PROMIS) Measures [Срок оценки: During the first 3 weeks and through one year follow up]
- Patient-Reported Outcomes Measurement Information System (PROMIS) Measures [Срок оценки: During the first 3 weeks and through one year follow up]
- Patient-Reported Outcomes Measurement Information System (PROMIS) Measures [Срок оценки: During the first 3 weeks and through one year follow up]
- Patient-Reported Outcomes Measurement Information System (PROMIS) Measures [Срок оценки: During the first 3 weeks and through one year follow up]
Критерии участия
Критерии включения
- Current diagnosis of PTSD or subthreshold PTSD; ability to speak and understand the English language; and ability to complete the informed consent process.
Критерии исключения
- Substance use disorder requiring medical management; imminent suicide risk warranting inpatient hospitalization or suicide-focused treatment; and impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- The Ohio State University — Columbus
Идентификаторы
NCT: NCT06285708 · 2023B0193