My MS Toolkit: An Internet-Based Depression Self-Management Program for Adults Living With Multiple Sclerosis
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: My MS Toolkit.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis, Multiple Sclerosis (MS). Базовые параметры: от 18 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
- США
- 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 →
Обзор
We are conducting this study to test if the new Toolkit depression module is accessible and helpful for people with multiple sclerosis (MS) in decreasing depression severity.
Подробное описание
First, we will modify My MS Toolkit to make it more helpful and relevant to adults with MS and depressive symptoms. We plan to add:
1. a depression-specific step with robust content about depressive symptoms, disorders, and treatments specific to MS 2. a depression quiz to help participants understand their depression symptoms and what Toolkit skills will be most helpful to them based on the quiz 3. more resources specific to depression self-management and care, including resources within the MS community 4. information on how to get mental health treatment if needed.
Second, we will evaluate the ease, convenience, and effectiveness of the improved My MS Toolkit. We will compare how well the Toolkit reduces people's feelings of depression compared to those who don't have access to the Toolkit. We will use website data to assess participant engagement and treatment ease, and explore factors like age, initial feelings of depression, and other symptoms that may impact outcomes. Understanding these factors will help determine who benefits most from My MS Toolkit and who might need different depression treatments.
Participants will either have access or no access to the Toolkit for 4 months and complete 3 online surveys over that time period.
Вмешательства
- Устройство My MS Toolkit
The My MS Toolkit is an online self-management intervention created for and in partner with people living with multiple sclerosis. With an approach based in cognitive behavioral therapy, this program guides users in building skills to help manage common symptoms of MS, such as fatigue, pain, and depression.
Первичные конечные точки
- Depressive Symptom Severity [Срок оценки: Baseline (prior to treatment), 12-week and 4-month]
Вторичные конечные точки (12)
- Sleep Disturbance [Срок оценки: Baseline (prior to treatment), 12-week, and 4-month]
- Fatigue Severity [Срок оценки: Baseline (prior to treatment), 12-week, and 4-month]
- Fatigue Impact [Срок оценки: Baseline (prior to treatment), 12-week, and 4-month]
- Pain Intensity [Срок оценки: Baseline (prior to treatment), 12-week, and 4-month]
- Anxiety [Срок оценки: Baseline (prior to treatment), 12-week, and 4-month]
- Pain Interference [Срок оценки: Baseline (prior to treatment), 12-week, and 4-month]
- Social Participation [Срок оценки: Baseline (prior to treatment), 12-week, and 4-month]
- Treatment Engagement [Срок оценки: 12-week and 4-month]
- Treatment Satisfaction [Срок оценки: 12-week and 4-month]
- Treatment Recommendation [Срок оценки: 12-week and 4-month]
- Perception of Change [Срок оценки: 12-week and 4-month]
- Self-Efficacy [Срок оценки: Baseline (prior to treatment),12-week, and 4-month]
Критерии участия
Критерии включения
- Self-reported diagnosis of MS (with screening questions such as current disease modifying therapy)
- At least 18 years of age
- Can read, write, and speak in English
- Score of >4 on the Patient Health Questionnaire, indicating at least mild depressive symptoms
- Have access to an internet-connected device for accessing the intervention
Критерии исключения
- Previous diagnosis of bipolar disorder or schizophrenia
- Started medication for depression or anxiety in the past 2 months
- Currently undergoing psychotherapy for depression
- Are of moderate or high risk for suicide on the Columbia Suicide Severity Rating Scale (C-SSRS)
- Participating in another clinical trial
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of Washington — Seattle
Идентификаторы
NCT: NCT07636434 · STUDY00023270 · RFA-2411-44095