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Идёт набор NCT05989841

Mitigating PTSD-CUD After Sexual Assault

Фаза I / Фаза II С лечением Posttraumatic Stress Disorder Cannabis Use 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: RISE Guide, Relaxation Control.
Кому может быть актуально
Состояния в реестре: Posttraumatic Stress Disorder, Cannabis Use Disorder. Базовые параметры: от 18 лет · Женщины.
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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Официальное название

Mitigating PTSD-CUD Among Women Presenting to Emergency Care After Sexual Assault: Testing a Digital Therapeutic Targeting Anxiety Sensitivity

Обзор

683,000 women are sexually assaulted annually in the United States, half of whom develop chronic posttraumatic stress disorder (PTSD) and thus have markedly increased risk for cannabis use disorder (CUD). The current proposal will test the acceptability, initial efficacy, and mechanisms underlying a novel digital therapeutic targeting risk for PTSD-CUD, which could address the critical need for PTSD-CUD prevention for the 100,000 women who annually present for emergency care after sexual assault. In this research context, the applicant will receive key training in multisite, emergency-care based randomized clinical trials (RCTs), advanced statistical analyses for RCTs and ecological momentary assessment data, biobehavioral mechanisms underlying PTSD-CUD prevention, and professional development, launching her independent research career focused on reducing the public health burden of PTSD-CUD among sexual assault survivors by leveraging digital therapeutics.

Вмешательства

  • Поведенческое RISE Guide
    Brief cognitive behavioral intervention completed in the 3 weeks post-assault delivered via Internet on participants' smartphones targeting anxiety sensitivity, or fear of anxious arousal. Patients learn psychoeducation regarding the nature of stress, cognitive retraining to reduce negative interpretations of stress, and how to complete interoceptive exposures to reduce anxiety sensitivity. These skills are supported by 6 concurrent then subsequent weeks of ecological momentary intervention to d
  • Поведенческое Relaxation Control
    Patients will download the "Breathe2Relax" app, which delivers information about how to use diaphragm breathing (taking slow, deep breaths through the diaphragm) to manage stress. Participants will receive reminders to engage with the intervention. Participants will also receive ecological momentary intervention reminders to engage with the relaxation intervention.

Первичные конечные точки

  • Anxiety Sensitivity Index-3 (ASI-3) [Срок оценки: 6 weeks]
Вторичные конечные точки (8)
  • Marijuana Problems Scale (MPS) [Срок оценки: 6 months]
  • Marijuana Motives Measure - Coping [Срок оценки: 6 months]
  • Patient Reported Outcome Measurement Information System - Anxiety Measurement Information System (PROMIS) Anxiety and Depression [Срок оценки: 6 months]
  • Patient Reported Outcome Measurement Information System - Depression Measurement Information System (PROMIS) Anxiety and Depression [Срок оценки: 6 months]
  • Cannabis Use Frequency [Срок оценки: 6 weeks]
  • Cannabis Use Quantity [Срок оценки: 6 weeks]
  • Marijuana Cravings - Emotionality Questionnaire [Срок оценки: 6 weeks]
  • PTSD Checklist for Diagnostic and Statistical Manual -5 (DSM-5) (PCL-5) [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Women sexual assault survivors presenting for emergency care <72 hours post-assault at 1 of our 4 emergency care sites
  • English speakers
  • 18+ years of age
  • Able to provide informed consent
  • Have a smartphone with continuous service >1 year
  • Report >1x/weekly cannabis use on a substance use screener
  • Report elevated AS (>17 on the Anxiety Sensitivity Index-3)

Критерии исключения

  • Inability to provide informed consent (e.g., serious injury preventing the ability to hear, speak, or see to consent and participate, or other causes (e.g., diagnosed cognitive deficits, diagnosed dementia, asleep at time of screening)).
  • Prisoner
  • Currently pregnant
  • Lives with assailant and plans to continue to do so
  • Admitted patient
  • No mailing address
  • Previously enrolled
  • No sexual assault nurse examiner (SANE) examination
  • Reporting current plan and intent for suicide or homicide
  • Does not understand written and spoken English

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
Профилактика

Центры проведения

США · 6 центров
  • Hennepin Assault Response Team — Minneapolis
  • University Medical Center — Las Vegas
  • UNC Chapel Hill — Chapel Hill
  • Harbor Shelter — Smithfield
  • Tulsa Forensic Nursing — Tulsa
  • SAFE Austin — Austin

Идентификаторы

NCT: NCT05989841 · UNLV-2023-649 · 1K23DA054299-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗