The Efficacy of an AI-Based Rehabilitation Treatment in Patients With Anxiety Disorders
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: AI-based rehabilitation treatment combined with standard treatment, Treatment as Usual (TAU).
- Кому может быть актуально
- Состояния в реестре: Anxiety Disorders. Базовые параметры: 18 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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Официальное название
A Randomized Controlled Trial Protocol Testing the Efficacy of an AI-Based Rehabilitation Treatment in Patients With Anxiety Disorders
Обзор
The trail aimed to test the efficacy of AI-based rehabilitation treatment in patients with anxiety disorders. Specifically, the objective of this trial is to determine whether the AI-based rehabilitation combined with treatment as usual is more effective than treatment as usual alone in improving outcomes in patients with anxiety disorders.
Подробное описание
This study aims to evaluate an AI-based rehabilitation system for delivering psychological intervention to patients with anxiety disorders. A randomized controlled single-blind trial design was employed to compare the clinical outcomes between patients receiving AI-based rehabilitation treatment combined with standard treatment and those receiving standard treatment alone, in order to evaluate the efficacy of the AI-based rehabilitation system. Additionally, system usability and acceptability will be assessed in the intervention group using standardized scales, evaluating ease of use, task efficiency, interaction quality, and overall user satisfaction, thereby providing evidence to support the clinical integration of AI technology in mental health interventions.
Вмешательства
- Устройство AI-based rehabilitation treatment combined with standard treatment
Participants were offered a 3-week psychological intervention , delivered by the AI-based rehabilitation system. The system contains 12 core topics, such as basic knowledge and emotion regulation, cognitive restructuring, behavior activation, interpersonal communication skills, mindfulness and sleep, and relaxation training. The intervention schedule was 4 sessions per week, each lasting approximately 20 minutes, for a total of 12 sessions. - Другое Treatment as Usual (TAU)
Both groups will receive treatment as usual, including medication, exercise and psychological education.
Первичные конечные точки
- Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7) [Срок оценки: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).]
Вторичные конечные точки (8)
- Change from baseline in depression status, as assessed by the Patient Health Questionnaire-9 (PHQ-9). [Срок оценки: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).]
- Change from baseline in social anxiety symptoms, as measured by the Liebowitz Social Anxiety Scale (LSAS). [Срок оценки: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).]
- Change from baseline in emotion regulation ability, as measured by the Emotion Regulation Questionnaire (ERQ). [Срок оценки: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).]
- Change from baseline in resilience level, as assessed by the Connor-Davidson Resilience Scale-10 (CD-RISC-10). [Срок оценки: Change from baseline in resilience level, as assessed by the Connor-Davidson Resilience Scale-10 (CD-RISC-10).]
- Change from baseline in insomnia severity, as assessed by the Insomnia Severity Index (ISI). [Срок оценки: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).]
- Change from baseline in functional impairment, as measured by the Sheehan Disability Scale (SDS). [Срок оценки: Assessed at baseline (T0), immediately post-intervention at week 3 (T1), and follow-up at week 7 (T2).]
- Patient Global Impression of Improvement [Срок оценки: Assessed at immediately post-intervention at week 3 (T1).]
- System usability, as assessed by the Mobile App Usability Questionnaire (MAUQ). [Срок оценки: Assessed at immediately post-intervention at week 3 (T1).]
Критерии участия
1\. Subjects with anxiety disorders
- Inclusion Criteria:
- In accordance with ICD-11 for Anxiety Disorders;
- Between the ages of 18-60;
- Completed at least 9 years of education;
- Ability to use computers or smartphone;
- Native Chinese speaker;
- Signing informed consent.
- Exclusion Criteria:
- With severe psychiatric symptoms requiring hospitalization, or unable to complete the required assessment and treatment;
- Use of cognitive-enhancing medications within the past 6 months;
- With intellectual, visual, or auditory impairments that affect their ability to interact with aided-diagnostic systems.
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Shanghai Mental Health Center — Шанхай
Идентификаторы
NCT: NCT07545070 · MZhao-027