Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom 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: cognitive-behavioral therapy and biofeedback therapy.
- Кому может быть актуально
- Состояния в реестре: Somatic Symptom Disorder. Базовые параметры: 20 лет — 70 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
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder: a Randomized Controlled Trial
Обзор
This research program is aimed to develop a integrative psychotherapy (including CBT and biofeedback therapy) and to examine its efficacy on treatment of somatic symptom disorder. The study design is a randomized controlled trial with waiting list control. Scores of Patient Health Questionniare-15 and Health Anxiety Questionnaire are the primary endpoints.
Подробное описание
Somatic symptom disorder (SSD) is a psychiatric disorder featured with somatic distress and related psychological phenomena. In the past several years, our research team has investigated several aspects of SSD, including psychopathology, epidemiology, mechanism, and diagnostic biomarkers. But the aspect about treatment on SSD has not been comprehensively explored.
In literature, the treatment of SSD can be separated into physical and psychological approaches. The physical approach includes pharmacotherapy and magnetic/electrical neuromodulation. Among several types of psychotherapies, cognitive behavioral therapy (CBT) has the most evidence. Previous studies have disclosed SSD patients to have following cognitive or behavioral features: selective attention on somatic distress; memory bias on the severe health conditions; all-or-none cognition about health; organic attribution style; catastrophizing cognitive pattern about health; high motivation of concerning issues about health; inadequate reassurance-seeking behavior; the assumption about the connection between rest and somatic distress, etc.
Biofeedback therapy works by measuring several biological signals related with stress and relaxation (such as heart rate, skin conductance, electromyography, electroencephalography, and finger temperature); feedback of these signals to the subjects can help them more clearly understand the association between their behavior/cognition and relaxation. Biofeedback therapy has been extensively applied in the psychosomatic field.
This research program is aimed to develop a integrative psychotherapy (including CBT and biofeedback therapy) and to examine its efficacy. The study design is a randomized controlled trial with waiting list control. Scores of Patient Health Questionniare-15 (PHQ-15) and Health Anxiety Questionnaire (HAQ) are the primary endpoints; the changes of other psychological and biological measurements are viewed as secondary endpoints.
Вмешательства
- Поведенческое cognitive-behavioral therapy and biofeedback therapy
Complete eight sessions of cognitive-behavioral therapy and biofeedback therapy within three months.
Первичные конечные точки
- Scores of Patient Health Questionnaire-15 (PHQ-15) [Срок оценки: Week 12 (comparing with the data in week 0)]
- Scores of Health Anxiety Questionnaire (HAQ) [Срок оценки: Week 12 (comparing with the data in week 0)]
Вторичные конечные точки (5)
- Scores of Beck Depression Inventory-II (BDI-II) [Срок оценки: Week 12 (comparing with the data in week 0)]
- Scores of Beck Anxiety Inventory (BAI) [Срок оценки: Week 12 (comparing with the data in week 0)]
- Scores of Cognitions About Body and Health Questionnaire (CABAH) [Срок оценки: Week 12 (comparing with the data in week 0)]
- Heart rate variability [Срок оценки: Week 12 (comparing with the data in week 0)]
- Skin conductance [Срок оценки: Week 12 (comparing with the data in week 0)]
Критерии участия
Критерии включения
- Patient with somatic symptom disorder (confirmed by psychiatrists)
Критерии исключения
- The age is younger than 20 or older than 70 years
- Having psychotic symptoms or cognitive impairment
- Having a potentially lethal illness
- Cannot read the questionnaires by oneself
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
Тайвань · 1 центр
- Department of Psychiatry, National Taiwan University Hospital Yunlin Branch — Yunlin
Идентификаторы
NCT: NCT05792930 · 202209093RIND