Идёт набор NCT06831435

Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study

Без фазы С лечением Depression Bipolar Affective Disorder Schizophenia Disorder Psychiatric &Amp;or Mood 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: a digital product based on CBT.
Кому может быть актуально: Состояния в реестре: Depression, Bipolar Affective Disorder, Schizophenia Disorder, Psychiatric &Amp;or Mood Disorder. Базовые параметры: 14 лет — 60 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: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The project proposes to develop a digital product based on cognitive behavioral therapy for the assisted treatment of depression. The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including AI-guided course work and homework. This study aims to evaluate the therapeutic effects of CBT-based digital products for depression in patients through a real-world study, and to explore its genetic and neuroimaging mechanisms.

Вмешательства

Устройство a digital product based on CBT
The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including Al-guided course work and homework.

Первичные конечные точки

Change from baseline in Hamilton Depression Rating Scale (HAMD) [Срок оценки: Week 4 and 8 of treatment duration]

Вторичные конечные точки (12)

Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Week 4 and 8 of treatment duration]
Change from baseline in Positive and Negative Syndrome Scale (PANSS) [Срок оценки: Week 4 and 8 of treatment duration]
Response to treatment [Срок оценки: Week 4 and 8 of treatment duration]
Clinical Global Impression-Severity of Illness (CGI-S) [Срок оценки: Week 4 and 8 of treatment duration]
Change from baseline in Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: Week 4 and 8 of treatment duration]
Change from baseline in Ruminative Responses Scale (RRS) [Срок оценки: Week 4 and 8 of treatment duration]
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Week 4 and 8 of treatment duration]
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC) [Срок оценки: Week 4 and 8 of treatment duration]
Change from baseline in Thinc-Integrated Tool(THINC-it) [Срок оценки: Week 8 of treatment duration]
Mood Disorder Questionnaire (MDQ) [Срок оценки: Week 4 and 8 of treatment duration]
Rating Scale for Side Effects（SERS） [Срок оценки: Week 4 and 8 of treatment duration]
Client Satisfaction Questionnaire-3 （CSQ-3) [Срок оценки: Week 8 of treatment duration]

Критерии участия

Критерии включения

Aged 14-60 years (including 14 and 60), no gender restriction;
HAMD >= 14;
Written informed consent obtained from the patient; written informed consent obtained from the guardian for minors.