Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers
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: Nurse-Supported Mobile App for Self-Help CBT-I, Sleep hygiene education.
- Кому может быть актуально
- Состояния в реестре: Insomnia Chronic, Cancer Caregivers. 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
- 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
Effect of Nurse-supported Mobile App for Self-help Cognitive Behavioral Therapy for Insomnia in Informal Cancer Caregivers: a Randomized Controlled Trial
Обзор
This mixed-methods randomized controlled trial investigates whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) effectively reduces insomnia severity among informal cancer caregivers, compared to sleep hygiene education.\<br\>\<br\> The primary research question is:\<br\> Does nurse-supported mobile app for self-help CBT-I lower insomnia severity among cancer caregivers compared to sleep hygiene education at post-intervention and 3-month follow-up?\<br\>\<br\> A total of 208 participants will:\<br\> 1. Be randomly assigned to one of two groups:\<br\> (i) the nurse-supported mobile app-based self-help CBT-I group, which involves a 6-week CBT-I program delivered via a WeChat mini program along with weekly nurse support sessions (up to 20 minutes each); or\<br\> (ii) the sleep hygiene education group.\<br\> 2. Complete assessments at baseline, post-intervention, and 3-month follow-up to measure changes in insomnia severity (primary outcome). Secondary outcomes include subjective sleep outcomes, psychological well-being, caregiver burden, fatigue, health-related quality of life, and participants' acceptability and satisfaction.\<br\>\<br\> As recommended for trials of complex interventions, investigators will conduct a process evaluation in alignment with the Medical Research Council (MRC) guidance. The key functions of the process evaluation include: \*(1) implementation, (2) mechanisms of impact, and (3) context.\*
Вмешательства
- Поведенческое Nurse-Supported Mobile App for Self-Help CBT-I
The intervention consists of two components: 1) a mobile app (i.e., WeChat mini program) delivered 6-week self-help CBT-I program; and 2) Weekly nurse support session (up to 20 minutes each) across a 6 week intervention period. - Поведенческое Sleep hygiene education
The participants in the control group will receive only sleep hygiene (one-page handout) via WeChat. Access to the CBT-I WeChat mini program will be offered to these participants after the completion of the 3-month follow-up assessment.
Первичные конечные точки
- Insomnia severity [Срок оценки: Baseline to 18 week]
Вторичные конечные точки (12)
- Sleep patterns [Срок оценки: Baseline to 18 week]
- Sleep quality [Срок оценки: Baseline to 18 week]
- Caregiver burden [Срок оценки: Baseline to 18 week]
- Depressive symptoms [Срок оценки: Baseline to 18 week]
- Anxiety symptoms [Срок оценки: Baseline to 18 week]
- Fatigue [Срок оценки: Baseline to 18 week]
- Health-related quality of life [Срок оценки: Baseline to 18 week]
- Participants' acceptability and satisfaction [Срок оценки: Week 6 to week 18]
- Adverse events [Срок оценки: Baseline to 18 week]
- Intervention delivery [Срок оценки: Six weeks post-randomization]
- Intervention acceptability [Срок оценки: 6 weeks post-randomization]
- Intervention fidelity [Срок оценки: 6 weeks post-intervention]
Критерии участия
Критерии включения
- Age ≥18 years
- Informal caregiver (e.g., family member or a friend) who co-resides with a cancer survivor of any site or stage and provides at least 4 hours of unpaid daily care. If two or more caregivers are available for a cancer survivor, the one providing most of the daily care will be included.
- Able to understand the research procedures, and read and communicate in Chinese
- Able to use WeChat
- Insomnia severity index scores > 7
Критерии исключения
- Another sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome, rapid eye movement behavior disorder), besides insomnia, that is not adequately treated
- Psychotic disorders (e.g., bipolar disorder, schizophrenia); Suicidal ideation with intent and plan OR attempted suicide within the past 2 months
- Currently taking any psychotropic drugs (e.g., antidepressants, anxiolytics, sleep medications)
- Unstable or acute medical condition or condition requiring surgery in the next 6 months; Pregnancy; or Epilepsy
- Currently participating in any other interventional program
- Prior experience with CBT-I
- Night, evening, early morning or rotating shift work
- Currently caring for a cancer patient receiving hospice care
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
Китай · 1 центр
- Shanghai University Shanghai Cancer Centre — Шанхай
Идентификаторы
NCT: NCT07089797 · Nurse-supported CBT-I (FULL)