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Идёт набор NCT05423444

Neural Connectivity During Therapy for Adolescent PTSD

Без фазы С лечением PTSD Adolescent Psychological Trauma

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: TF-CBT, TAU.
Кому может быть актуально
Состояния в реестре: PTSD, Adolescent, Psychological Trauma. Базовые параметры: 12 лет — 17 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 →
Официальное название

Neural Connectivity Before and After Each of the Three Treatment Phases of Trauma-focused Therapy for Adolescent Posttraumatic Stress

Обзор

Posttraumatic stress disorder in adolescence impairs neurobiological networks underlying cognitive, social and emotional skills. Neuroimaging research that seeks to identify the neural mechanisms of treatments for PTSD could lead to novel treatments, but progress has been slow using current methods. The proposed study uses an innovative approach to identify neural mechanisms of specific phases of trauma-focused therapy for youth with PTSD, allowing a new understanding of brain changes associated with the process of therapy.

Подробное описание

Posttraumatic stress disorder (PTSD) during adolescence negatively impacts brain networks underlying cognitive, social, and emotional function. Early intervention is important for mitigating long-term effects, but about 20% of youth do not improve sufficiently with current approaches. By identifying the neurobiological mechanisms of effective therapies, the investigators facilitate the development of novel or personalized treatment approaches for youth with PTSD. However, there has been limited progress in identifying the neural mechanisms of treatment using neuroimaging, partly because most studies collect neuroimaging data at only baseline and end-of-treatment, which collapses across multiple parts of the therapeutic process. The objective of the proposed study is to take a new approach by identifying neural mechanisms associated with specific phases of trauma therapy for youth with PTSD. The central hypothesis is that each phase produces specific brain changes that reflect the acquisition of skills and experiences occurring during that phase. Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is evidence-based and widely-used to treat children and adolescents with PTSD. It consists of 3 well-defined phases, providing an opportunity to test hypotheses with neuroimaging: changes in executive control networks will occur during the skills phase, changes in limbic networks during the narrative phase, and changes in default mode networks during the consolidation phase. To test these hypotheses, the investigators will recruit N=180 girls and boys, ages 12-17, who have PTSD following interpersonal trauma, such as physical abuse, sexual abuse, or witnessing violence. A randomized controlled trial design will be used to assign participants to either Trauma-focused Cognitive Behavioral Therapy (TF-CBT; provided by study team clinicians who meet fidelity standards) or Treatment as Usual (TAU; provided in the community and does not follow a phased structure). Functional magnetic resonance imaging (fMRI) data will be collected before and after each of the 3 phases of TF-CBT or the same time intervals of TAU. Individual differences in age, sex, dissociative subtype, symptom severity and other variables will be investigated as covariates of phase-related neural changes. Analyses will identify the phases of TF-CBT for which brain regions and networks change for the TF-CBT but not the TAU group. The phase(s) that best predict end-of-treatment symptom improvement also will be identified. Exploratory analyses will use neuroanatomical and white matter diffusivity scans to identify co-occurring changes in brain structure. The proposed innovative study will provide novel information on the neurobiological and cognitive mechanisms associated with the process of trauma therapy for youth with PTSD.

Вмешательства

  • Поведенческое TF-CBT
    evidence-based psychotherapy for trauma in youth
  • Поведенческое TAU
    treatment as usual

Первичные конечные точки

  • Mean intensity within functional connectivity map of intrinsic network [Срок оценки: week 0 (baseline)]
  • Mean intensity within functional connectivity map of intrinsic network [Срок оценки: week 6]
  • Mean intensity within functional connectivity map of intrinsic network [Срок оценки: week 12]
  • Mean intensity within functional connectivity map of intrinsic network [Срок оценки: week 18]
Вторичные конечные точки (1)
  • Clinician Administered PTSD Scale - children and adolescents (CAPS-CA) [Срок оценки: Baseline to week 18]

Критерии участия

Критерии включения

  • ages 12-17 and Tanner stage 2 or above
  • history of interpersonal trauma
  • PTSD symptoms with a rating of '2' or higher on at least one symptom from each of the 4 clusters, using the Clinician-Administered PTSD Scale for Children and Adolescents, and having a duration of at least one month

Критерии исключения

  • current or past use of psychiatric medications
  • severe suicidal/homicidal ideation
  • current hospitalization
  • other current psychotherapy or previous treatment with TF-CBT
  • history of head injury with loss of consciousness for >5 minutes
  • IQ<85
  • major medical illness
  • MRI contraindications (metal in body; braces on teeth)
  • psychosis, bipolar 1, autism, developmental disorder, panic disorder
  • first-degree family member with diagnosis of psychosis or bipolar I disorder
  • substance dependence within the past 3 months or current drug use that is frequent

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
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • UT Health Department of Psychiatry — San Antonio

Идентификаторы

NCT: NCT05423444 · HSC20220498H · R01MH127216

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗