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Идёт набор NCT04529031

Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry

Без фазы С лечением Posttraumatic Stress Disorder

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: Reminder Focused Positive Psychiatry, attentional control condition (group process).
Кому может быть актуально
Состояния в реестре: Posttraumatic Stress Disorder. Базовые параметры: 11 лет — 15 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
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Официальное название

Clinical and Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry in Adolescent With Posttraumatic Stress Disorder

Обзор

Objective: Posttraumatic stress disorder (PTSD) is a prevalent neuropsychiatric disorder in children and is associated with increased neurovascular inflammation, suicidality, adulthood mental health disorder, and major adverse events. Reminder focused positive psychiatry (RFPP) has been shown as well tolerated feasible trauma focused intervention that is associated with improved core PTSD symptoms, decreased severity of reactivity to PTSD trauma reminders, and increased vascular function. This study evaluates the clinical and biomolecular characteristics of RFPP in adolescents with PTSD. Research Design/Overall Impact: After obtaining parents' informed consent and adolescent's assent, 60 adolescents aged 11-15 years old with PTSD, and free of known medical and other major psychiatric disorders will be recruited from the pool of eligible adolescents at Olive View UCLA Pediatrics Clinics (\>3000 adolescents with PTSD). Eligible adolescents will be randomized to 1) RFPP group intervention, or 2) an attentional control condition (group process). Thirty subjects in each group will receive twice weekly telehealth intervention of either RFPP or group process, for 6 weeks, and undergo 4 blinded neuropsychiatric assessments at baseline, 3, 6, and 24 weeks. Parents will receive weekly interventions of either positive psychoeducation or group process, for 6 weeks and undergo baseline, 3, 6- and 24-weeks neuropsychiatric assessment. Vascular function, inflammatory biomarkers including CRP, homocysteine, and stress involved gene expression biomarkers (i.e. changes in gene expression of FKBP5, DDX6, B2M, LAIR1, RTN4, NUB1, and a multi-gene Conserved Transcriptional Response to Adversity score (CTRA) will be measured at baseline and 6-week. The primary and secondary endpoints are a) changes in PTSD core and reactivity to trauma reminder severity score in response to RFPP intervention, b) changes in wellbeing, biopsychosocial trait, vascular function, neuroinflammation and gene expression biomarkers in response to RFPP, and c) changes in parents' wellbeing and biopsychosocial trait as well as child-parent interactions.

Вмешательства

  • Поведенческое Reminder Focused Positive Psychiatry
    The focus of RFPP is on enhancing contextual discrimination and emotional regulation, and promoting the use of adaptive coping strategies in response to trauma reminders, including recognizing reminders, shifting attention from intrusive memories during exposure to reminders to a focus on positive feelings, thoughts, goals, and choices
  • Поведенческое attentional control condition (group process)
    This group process will undergo telehealth relaxation therapy twice a week for 6-week. Subjects will receive progressive muscle relaxation and other relaxation techniques as well as education about PTSD and supportive psychotherapy

Первичные конечные точки

  • To examine the impact of RFPP intervention on core PTSD symptoms [Срок оценки: 24 months]
Вторичные конечные точки (2)
  • To assess the impact of RFPP on well-being of adolescents with PTSD and their parents [Срок оценки: 24 months]
  • To examine the impact of RFPP on biologic biomarkers, compared to control group [Срок оценки: 24 months]

Критерии участия

Критерии включения

  • Boy/Girl with documented PTSD,
  • aged 11- 15 years old,
  • able to read/write in English

Критерии исключения

  • presence of intellectual disabilities,
  • presence of psychotic or self-injurious behavior,
  • presence of seizure disorder,
  • presence of language disorder,
  • presence of eye disorders,
  • presence of other neurodevelopmental disorders,
  • presence of diagnosis of substance use disorder.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UCLA — Los Angeles

Идентификаторы

NCT: NCT04529031 · IRB#20-000444

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗