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Идёт набор NCT04895995

Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population

Без фазы С лечением Anxiety Disorders Cardiovascular Diseases Anxiety Health Behavior

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: Daylight dCBT Application.
Кому может быть актуально
Состояния в реестре: Anxiety Disorders, Cardiovascular Diseases, Anxiety, Health Behavior. 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
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Обзор

The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control).

Подробное описание

The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. A recent large-scale efficacy trial of digital cognitive behavior therapy (dCBT) for GAD demonstrated significant benefit relative to waitlist control with a large effect size. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention, followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control). Assessments will occur at Week 0 (baseline), Week 3, Week 6, and Week 10 (post-treatment).

Вмешательства

  • Поведенческое Daylight dCBT Application
    Participants will complete up to four modules of digital intervention delivered in a self-paced format.

Первичные конечные точки

  • Generalized Anxiety Disorder Scale (GAD-7) [Срок оценки: Week 10 (post-treatment)]
Вторичные конечные точки (12)
  • Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear) [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • Smoking History Questionnaire [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • International Physical Activities Questionnaire (IPAQ) [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • Modified Morisky Scale [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • Center for Epidemiological Studies Depression Scale 10 Item Version [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • Sleep Condition Indicator (SCI-8) [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • Short Form Health Survey (SF-12) [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • Anxiety Sensitivity Inventory (ASI-3) [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • Penn State Worry Questionnaire (PSWQ) [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • Shame Inventory-Part 1 (SI-P1) [Срок оценки: Week 0, Week 6, and Week 10 (post-treatment)]
  • Generalized Anxiety Disorder Scale (GAD-7) [Срок оценки: Week 0, Week 3, Week 6]

Критерии участия

Критерии включения

  • Experienced an acute CVD event (i.e., myocardial infarction, stroke/transient ischemic attack, cardiac arrest, unstable angina, congestive heart failure with hospitalization; exclusion of coronary heart disease, atrial fibrillation, and other arrhythmias)
  • Clinical levels of GAD symptoms as operationalized by a score of ≥10 on the GAD-7
  • Age 18 or older.
  • Individuals must be in the post-acute phase of their CVD; this is operationalized as > 2 months post an acute cardiac event.

Критерии исключения

  • Non-English speaker/literate
  • No access to a digital device
  • Severely vision impaired
  • Severe cognitive impairment
  • Pending acute surgery or with a life prognosis of fewer than 6 months
  • The presence \[by self-report\] of schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder other than nicotine
  • Initiation or change of psychotropic medication dosage within the past 4 weeks
  • Received CBT for anxiety in last 3 months

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
  • Boston University — Boston

Публикации

  • Parsons EM, Hiserodt M, Otto MW. Initial assessment of the feasibility and efficacy of a scalable digital CBT for generalized anxiety and associated health behaviors in a cardiovascular disease population. Contemp Clin Trials. 2023 Jan;124:107018. doi: 10.1016/j.cct.2022.107018. Epub 2022 Nov 19. PMID 36414206

Идентификаторы

NCT: NCT04895995 · 6035E

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗