ZeroOCD: Learn to Overcome Contamination OCD With Your Smartphone
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: ZeroOCD, Videoconferencing CBT.
- Кому может быть актуально
- Состояния в реестре: Obsessive Compulsive Disorder (OCD). Базовые параметры: 18 лет — 64 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
- Бельгия, Нидерланды, Швеция, Швейцария
- 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
ZeroOCD: Learn to Overcome Contamination OCD With Your Smartphone: An Augmented Reality Cognitive Behavioral Therapy App for Obsessive-Compulsive Disorder: Randomized Controlled Trial
Обзор
This study is a three-arm randomized controlled trial designed to evaluate the efficacy of a smartphone-based augmented reality (AR) cognitive behavioral therapy (CBT) app, called ZeroOCD, for individuals with elevated contamination-related obsessive-compulsive disorder (OCD) symptoms. The AR-CBT app will be compared to both an active control condition (manualized CBT via videoconferencing) and a waitlist control group.
Подробное описание
Obsessive-compulsive disorder (OCD) is a prevalent and disabling condition, with contamination fears being one of its most common presentations. While Cognitive-Behavioral Therapy (CBT) with Exposure and Response Prevention (ERP) is a first-line treatment, many individuals face barriers to accessing it, such as cost, stigma, and availability of therapists. This multicenter trial, conducted in the Netherlands, Belgium, Sweden, and Switzerland, will recruit a total of 189 individuals experiencing contamination-related obsessive-compulsive symptoms. Participants will be randomized to one of three study conditions (allocation ratio 2:2:1): The first group (n = 75) receives access to ZeroOCD, an augmented reality (AR) based smartphone application, which provides CBT and ERP for contamination fears, along with three therapist support sessions via videoconferencing. The second group (n = 75) receives weekly CBT for OCD via videoconferencing (nine sessions in total). The third group is a waitlist control group (n = 39), who will receive access to the smartphone application with minimal therapist support on request after 10 weeks in the study. The study aims to evaluate the effectiveness of the ZeroOCD intervention compared to both a waitlist control and videoconferencing CBT, and to assess cost-effectiveness and usability. Assessments are conducted at baseline, 10 weeks post-randomization, and at 6-month follow-up for the intervention groups. Participants in the waitlist group complete assessments at baseline, 10 weeks post-randomization, and receive access to the ZeroOCD intervention 10 weeks after randomization. Further, the waitlist group will complete an assessment 20 weeks post-randomization. The study is a multicenter trial involving participants in Switzerland, the Netherlands, Belgium, and Sweden.
Вмешательства
- Поведенческое ZeroOCD
The ZeroOCD app contains the following components: psychoeducation, detecting obsessive thoughts, coping with obsessions, goal setting, fear curve explanation, exposure with AR, re-exposure with AR, exposure hierarchy, exposure in real-life, re-exposure in real life and relapse prevention - Поведенческое Videoconferencing CBT
Videoconferencing CBT contains the following chapters: psychoeducation, detecting obsessive thoughts, coping with obsessions, goal setting, fear curve explanation, exposure hierarchy, exposure in real-life, re-exposure in real life and relapse prevention
Первичные конечные точки
- OCD Symptoms (Interview) [Срок оценки: At baseline, At 10 weeks, At 20 weeks (only WL condition) At 24 weeks]
Вторичные конечные точки (12)
- OCD symptoms (Self-report) [Срок оценки: At baseline, During treatment (every week) At 10 weeks, At 24 weeks]
- Fear of Contamination [Срок оценки: At baseline, At 10 weeks, At 20 weeks (only WL condition) At 24 weeks]
- Depression [Срок оценки: At baseline, At 10 weeks, At 24 weeks]
- Anxiety [Срок оценки: At baseline, At 10 weeks, At 24 weeks]
- Current Distress/Disgust [Срок оценки: up to ten weeks]
- Social Functioning [Срок оценки: At baseline, At 10 weeks, At 24 weeks]
- Health Related Quality of Life [Срок оценки: At baseline, At 10 weeks, At 24 weeks]
- Societal Costs of a Treatment [Срок оценки: At baseline, At 10 weeks, At 24 weeks]
- Usability [Срок оценки: At 10 weeks (only ZeroOCD condition), At 20 weeks (only WL condition)]
- Treatment Satisfaction [Срок оценки: At 10 weeks (only intervention groups)]
- Realism of AR-Environment [Срок оценки: At 10 weeks (only ZeroOCD condition)]
- Negative Effects of Treatment [Срок оценки: At 10 weeks (only ZeroOCD and CBT condition), at 20 weeks (only waitlist condition)]
Критерии участия
Критерии включения
- • OCD symptoms, mean score > 7 on the Yale Brown Obsessive Compulsive Scale (Y-BOCS)
- Fear of contamination OCD symptoms, mean score > 6 on the Padua Inventory contamination fear subscale (PI)
- Having access to a compatible smartphone
- Having an internet connection
- Proficiency in one of the countries' languages (i.e., Dutch/ Flemish, German, or Swedish)
- Willing to participate in the research study and provide informed consent
Критерии исключения
- • Having been diagnosed with bipolar or psychotic disorder (self-report)
- Severe depressive symptoms (Patient Health Questionnaire, PHQ-9, score > 20)
- Reporting suicidality (PHQ-9, item 9 > 2 points at screening)
- Fear of contamination due to disorder other than OCD (clinical judgment based on results from the Yale Brown Obsessive Compulsive Scale, Y-BOCS, Generalized Anxiety Disorder-7 items, GAD-7, Short Health Anxiety Inventory, SHAI)
- Parallel psychological treatment
- Non-stable dosage of psychoactive medication during the last three months or planned changes during the study period.
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
Бельгия · 1 центр
- Thomas More Mechelen — Mechelen
Нидерланды · 1 центр
- Vrije Universiteit Amsterdam — Amsterdam
Швеция · 1 центр
- Stockholm University — Stockholm
Швейцария · 1 центр
- UBERN — Bern
Идентификаторы
NCT: NCT07194473 · ZeroOCD/FP-1478