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Идёт набор NCT07013578

TIDHI Mental Health in IBD Patients Study

Без фазы С лечением Crohn Disease (CD) Ulcerative Colitis (UC) Inflammatory Bowel Disease (IBD)

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: Healing Circuits™ sessions, self-directed Healing Circuits™ curriculum.
Кому может быть актуально
Состояния в реестре: Crohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD). Базовые параметры: 18 лет — 75 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
Канада
Следующий шаг
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Официальное название

A Randomized Evaluation of Changes in Anxiety and Depression in Inflammatory Bowel Disease Patients Comparing Structured Mental Health Support to App Based Mental Health Support in Addition to Standard of Care Medical Treatment

Обзор

The purpose of this study is to test the impact of Healing Circuits™; a structured mental health support model on IBD patients. The eligible study participants will be randomly divided into two groups: 1. the group receiving structured mental health support with a social worker and 2. the group receiving structured mental health support via a self-directed online curriculum. Both groups will be receiving the same type of therapy, Healing Circuits™, but the group receiving the therapy via the online self-directed curriculum will be receiving the therapy mostly by web-based video instruction. The two groups will be evaluated over a period of 12 months.

Вмешательства

  • Поведенческое Healing Circuits™ sessions
    Treatment of the Study group will involve 12-weekly 50-minute sessions with a social worker who has been trained in the Healing Circuits™ Methodology - a structured mental health support delivered by a therapist in a one-on-one model.
  • Поведенческое self-directed Healing Circuits™ curriculum
    Treatment of the Control group will involve 12 weekly online modules of a self-directed Healing Circuits™ curriculum - structured mental health support being delivered in an web-based video instruction model.

Первичные конечные точки

  • Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score [Срок оценки: 3 months following initiation of Healing Circuits™]
  • Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score [Срок оценки: 3 months following initiation of Healing Circuits™]
  • Change in Patient Health Questionnaire-9 (PHQ-9) Score [Срок оценки: 3 months following initiation of Healing Circuits™]
  • Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score [Срок оценки: 3 months following initiation of Healing Circuits™]
Вторичные конечные точки (4)
  • Proportion of Participants Achieving at Least a 2-Point Reduction in GAD-7 Score [Срок оценки: 6, 9, and 12 months following initiation of Healing Circuits™]
  • Proportion of Participants Achieving at Least a 2-Point Reduction in PHQ-9 Score [Срок оценки: This outcome measures the proportion of participants who experience a reduction of at least 2 points in the PHQ-9 (range: 0-27, higher scores = worse depression) at 6, 9, and 12 months after beginning the Healing Circuits™ intervention.]
  • Mean Change in 36-Item Short Form Survey (SF-36) Score Between Groups [Срок оценки: 3, 6, 9, and 12 months following initiation of Healing Circuits™]
  • Mean Change in Patient Satisfaction Score on a Likert Scale Between Groups [Срок оценки: 3, 6, 9, and 12 months following initiation of Healing Circuits™]

Критерии участия

Критерии включения

Subjects must meet each of the following criteria for enrolment into the study:

  • Written informed consent must be obtained and documented.
  • Males and females between the ages of 18 and 75 years of age with documented diagnosis of IBD.
  • GAD7 and/or PHQ9 score of 10 - 15.
  • Ability of subject to participate fully in all aspects of this clinical trial.
  • IBD patients who plan to have ongoing medical care at TIDHI.

Критерии исключения

Subjects who exhibit any of the following conditions are to be excluded from the study:

  • Plan for change in systemically delivered IBD-related medical therapy in the 3 months after screening.
  • Serious underlying psychiatric disorder such as schizophrenia or bipolar disorder.
  • Planned change in psychiatric medication, if any is being taken, within 3 months after screening.
  • History of illegal drug abuse (excluding marijuana) or alcohol abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures

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

Канада · 1 центр
  • Toronto Immune and Digestive Health Institute — North York

Идентификаторы

NCT: NCT07013578 · 3665

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗