ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive 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: ICBT.
- Кому может быть актуально
- Состояния в реестре: Obsessive-Compulsive Disorder. Базовые параметры: 18 лет — 65 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
- Португалия
- 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
ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy from Changes in the Neurobiological Correlates of Emotion Regulation in Obsessive-compulsive Disorder
Обзор
In the current study, the investigators will characterize obsessive-compulsive disorder (OCD) patients and healthy controls with a comprehensive clinical and neuroimaging assessment, focusing on the basic psychological processes related and on the neurobiological underpinnings of emotion regulation (ER). After a baseline assessment, the investigators will implement an internet-based cognitive behavioral therapy (iCBT) protocol and assess its efficacy on the modulation of ER and OCD severity. Specifically, the investigators will (1) examine to what extent the iCBT intervention modulates ER and the associated neurobiological mechanisms and (2) identify candidate biomarkers of successful treatment response.
Подробное описание
Sixty patients and sixty controls will be recruited at Hospital de Braga, Braga, Portugal (sample size estimated based on a previous systematic review). A power analysis indicated that a sample of 24 individuals per group is adequate to detect an effect size of d=.89, with a Type I error of .05 and a statistical power of .85. A final sample of 30 individuals was defined to account for a 20% dropout rate during the intervention.
All participants will be assessed with a comprehensive psychological and clinical characterization. Following the baseline assessment, OCD patients will be randomly allocated to the intervention (iCBT intervention) or the control group (waiting list). The iCBT intervention will consist of a structured program comprising 10 modules with text and video content, as well as 3 videoconferencing psychotherapy sessions. After the intervention/waiting list, patients will be re-assessed with the clinical and psychological assessment.
In order to characterize the patterns of brain activation in OCD patients during an emotion regulation task in comparison to healthy controls and to identify potential neurobiological markers of symptoms' improvement, a multimodal neuroimaging assessment will also be performed. The task encompasses the presentation of pictures (fearful, neutral and OCD-related stimuli) under two conditions: the instruction to view the pictures naturally ('observe'); or to apply cognitive reappraisal techniques to decrease any negative affective state caused by the stimuli ('regulate'). Fear and OCD-related pictures are presented during both conditions; neutral pictures only during 'observe'. After each stimulus, the level of distress will be assessed by a self-report rating scale.
In the baseline assessment, brain activation patterns (with whole-brain and region of interest approaches) will be compared between OCD and healthy controls in both task conditions. After intervention, emotion regulation ability and the underlying neurobiological mechanisms will be compared between the 'intervention' and 'waiting list' groups.
Вмешательства
- Поведенческое ICBT
The intervention will consist in a structured internet-based intervention with 10 modules that will combine cognitive-behavioral techniques to improve obsessive-compulsive symptoms as well as the emotion regulation ability.
Первичные конечные точки
- Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Срок оценки: immediately before and immediately after intervention/waitlist]
Вторичные конечные точки (11)
- Obsessive-Compulsive Inventory- Revised [Срок оценки: baseline; 4 weeks after beginning intervention/waitlist; 8 weeks after beginning; 12 weeks after beginning intervention/waitlist and immediately after intervention/waitlist]
- Hamilton Anxiety Scale [Срок оценки: immediately before and immediately after intervention/waitlist]
- Hamilton Depression Scale [Срок оценки: immediately before and immediately after intervention/waitlist]
- Perceived Stress Scale [Срок оценки: immediately before and immediately after intervention/waitlist]
- Emotion Regulation Questionnaire [Срок оценки: immediately before and immediately after intervention/waitlist]
- Difficulties in Emotion Regulation Scale [Срок оценки: immediately before and immediately after intervention/waitlist]
- Positive and Negative Affect Schedule [Срок оценки: immediately before and immediately after intervention/waitlist]
- Depression Anxiety Stress scale [Срок оценки: baseline; every week during intervention/wait list (up to 14 weeks) and immediately after intervention/waitlist]
- NEO Five-Factor Inventory [Срок оценки: baseline]
- Treatment Acceptability/Adherence Scale [Срок оценки: immediately after intervention]
- University of Rhode Island Change Assessment Scale [Срок оценки: baseline]
Критерии участия
Критерии включения
- Primary diagnosis of current OCD according to the fifth Diagnostic and Statistical Manual of Mental Disorders
- YBOCS score ≥ 16
- Psychotropic medication, if stable for at least 2 months prior to inclusion and if the dosage is maintained thoughout the study
- Have the resources to access the online intervention (internet access; computer or tablet)
Критерии исключения
- MRI contraindications
- Prior medical history of neurological disorders or traumatic brain injury
- Having performed CBT treatment for OCD in the last 2 years
- Undergoing any psychological treatment
- Suicidal ideation
- Current alcohol or drug abuse
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Португалия · 1 центр
- Life and Health Sciences Research Institute, School of Medicine, University of Minho — Braga
Идентификаторы
NCT: NCT05906069 · iTREATOCD_ICVS2022