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Набор по приглашению NCT05821634

Personalizing Treatment Delivery

Без фазы С лечением Anxiety Disorders and Symptoms PTSD and Trauma-related Symptoms Alcohol; Use, Problem; Alcohol 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: Personalized intervention condition: Cognitive behavioral therapy skills, Therapeutic control condition: Cognitive behavioral therapy skills, Tracking control condition: Supportive counseling.
Кому может быть актуально
Состояния в реестре: Anxiety Disorders and Symptoms, PTSD and Trauma-related Symptoms, Alcohol; Use, Problem; Alcohol Use Disorder. Базовые параметры: 18 лет — 65 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

Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Comorbidity and Treatment

Обзор

Anxiety and anxiety-related disorders frequently co-occur with alcohol use problems resulting in an enormous humanitarian and economic cost to society. The proposed research will use digital technology to examine person-specific risk factors predicting problematic alcohol use in individuals vulnerable to anxiety and anxiety-related disorders and will use this information to design a personalized intervention for individuals seeking psychological treatment. Results from this research will integrate output from novel and innovative digital technology methods into psychotherapy, advancing research on personalized treatment and prevention efforts.

Вмешательства

  • Поведенческое Personalized intervention condition: Cognitive behavioral therapy skills
    An 11-session cognitive behavioral therapy (CBT) skills based intervention will be delivered to participants randomized to the personalized intervention. Influential constructs will be identified using the person specific digital phenotyping model, targeted using CBT skills, and tracked across sessions.
  • Поведенческое Therapeutic control condition: Cognitive behavioral therapy skills
    Participants randomized to this condition will receive an 11-session CBT skills based treatment targeting a non-personalized construct selected from the person-specific digital phenotyping model.
  • Поведенческое Tracking control condition: Supportive counseling
    Participants randomized to this condition will receive 11 supportive counseling sessions that are non-directive in nature (providing support and validation for non-acute weekly stressors). Participants will continue digital phenotyping, controlling for the effect of counseling and digital phenotyping.

Первичные конечные точки

  • Change in alcohol related risk [Срок оценки: Week 3, Week 15 (approximate)]
  • Change in risk drinking levels [Срок оценки: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]
  • Change in anxiety or anxiety-related symptom severity [Срок оценки: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]
  • Change in psychiatric diagnoses [Срок оценки: Week 3, Week 15 (approximate)]
Вторичные конечные точки (4)
  • Number of sessions attended [Срок оценки: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]
  • Change in therapeutic alliance [Срок оценки: Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]
  • Patient-rated assessment of progress [Срок оценки: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]
  • Clinician-rated improvement in functioning [Срок оценки: Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)]

Критерии участия

Критерии включения

  • Access to a smart phone
  • Between 18 and 65 years
  • Clinically significant anxiety or trauma-related symptoms
  • Alcohol use problems
  • Interest in telehealth counseling
  • Anticipated New Jersey or New York residence for the duration of the study

Критерии исключения

  • Currently receiving individual counseling or counseling at a higher level of care
  • Psychiatric medication that is not currently at a stable dose (or is not anticipated to remain at a stable dose for the duration of the study)
  • Demonstrated indicators of more intensive or acute care
  • Temporary residence within the state of New Jersey or New York or out-of-state residence from the state of New Jersey or New York

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
Лечение

Центры проведения

США · 1 центр
  • Rutgers Robert Wood Johnson Medical School — Piscataway

Идентификаторы

NCT: NCT05821634 · STUDY00013899 · 4R00AA029459-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗