Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Depression (Trial 2 of 3)
Remote vs. In-Person Study Evaluation (RISE) Above Depression
The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Larry W. Hawk, PhD
- Номер телефона: 716-645-0192
- Электронная почта: lhawk@buffalo.edu
Места учебы
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South Carolina
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Charleston, South Carolina, Соединенные Штаты, 29425
- Medical University of South Carolina
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
INCLUSION CRITERIA:
Common to all 3 RCTs:
- age18+ years
- stable mailing address (for mailing study packets if assigned to Remote Intake and/or Remote Treatment/Assessment) within accessible range (1.5 hours) of each study site (per self report)
- able to read, speak & verbally comprehend English
- currently own an iOS- or Android-compatible smartphone
- have a valid e-mail address that is checked regularly (at least once per day) or have regular access to text messages (to access follow-up assessments)
Specific to RCT 2:
e) Elevated depressive symptoms, defined as a score of > 10 on the Patient Health Questionnaire-9 (PHQ-9) f) Report willingness to utilize a mobile app for the treatment for depressed mood (response of "yes" on yes/no item)
EXCLUSION CRITERIA:
Common to All 3 RCTs:
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consumption of >28 alcohol-containing drinks per week
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suicide attempt with at least some wish to die in past 3 months
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mental illness (such as schizophrenia, bipolar disorder, or major depression) that led to hospitalization in the past 30 days
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unable/unwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations
Specific to RCT2:
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Current suicidal ideation at study screening, defined as a response of ≥ 1 on item nine ("Thoughts that you would be better off dead, or of hurting yourself") of the PHQ-9
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: REMOTE intake AND REMOTE treatment/assessment
In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits. |
All participants receive the mobile health application "Moodivate". |
|
Другой: REMOTE intake BUT IN-PERSON treatment/assessment
In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits. |
All participants receive the mobile health application "Moodivate". |
|
Другой: IN-PERSON intake, BUT REMOTE treatment/assessment
In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits. |
All participants receive the mobile health application "Moodivate". |
|
Другой: IN-PERSON intake AND IN-PERSON treatment/assessment
In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits. |
All participants receive the mobile health application "Moodivate". |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Trial Quality: Retention
Временное ограничение: ~3 months
|
Retention will be assessed using visit milestone data to determine whether each participant achieved each T/A Visit (Visits 2-5) following T/A initiation at T/A Visit 1. We will calculate a continuous metric of retention (0-4; the number of visits completed) for each participant, supplemented by visit-specific data to provide a detailed examination of the time course and overall amount of retention. |
~3 months
|
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Accrual efficiency/Pre-treatment visits
Временное ограничение: ~1 month
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Calculated from visit milestones. Percentage of screen-eligible participants who attend the Intake Visit after randomization to Remote vs In-Person Intake. Additional accrual metrics include 1) Intake-to-Treatment/Assessment Visit 1 completion and 2) Overall pre-treatment accrual (Brief Screen to Treatment/Assessment Visit 1 |
~1 month
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Trial Quality: Treatment utilization
Временное ограничение: ~3 months (assessed from T/A1 [when app is distributed] through T/A5)
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Participant engagement with the Moodivate mobile application pulled directly from the Moodivate analytics data. The primary outcome will be the percentage of days in which the app was used (from T/A 1 until T/A 5). Additional secondary outcomes include: the number of sessions of app use, average time per session, and total time using the app, as well as fidelity metrics (number of goals created and the number of activities created, scheduled, and completed). |
~3 months (assessed from T/A1 [when app is distributed] through T/A5)
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Trial quality: Biospecimen completion rates
Временное ограничение: ~3 months (assessed at T/A Visits 1,2, 3, 4, and 5)
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The number of saliva samples completed/returned for Treatment/Assessment visits 1-5 that each participant attended. Remote participants return samples by mail; to count as completed/returned, the mailed package must be postmarked within 7 days of the visit. |
~3 months (assessed at T/A Visits 1,2, 3, 4, and 5)
|
Соавторы и исследователи
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- STUDY00010275
- 4UH3TR004797 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
We plan to make available the full de-identified data set with metadata through the NAHDAP, a NIDA-funded platform for data sharing/archiving, with a topical focus on behavioral health data. NAHDAP operates under the umbrella of the ICPSR, based at the University of Michigan. Per the ICPSR website, the ICPSR is "the largest social science data archive in the world".
Сроки обмена IPD
The study protocol and informed consent form will be shared at risetrials.org by 12/31/26.
Consistent with NIH and Institute of Medicine recommendations, the data will be deposited no later than the publication of the primary study data or one year after each RCTs completion, whichever comes first. There is no planned end date.
Критерии совместного доступа к IPD
The study protocol and informed consent form will be shared at risetrials.org by 12/31/26.
Data submitted for archiving/sharing will be consistent with Inter-university Consortium for Political and Social Research (ICPSR) and the National Addiction and HIV Data Archive Program (NAHDAP) data standards and data stewardship policies and will contain no personal identifiers. Typically, the data are publicly available via a unique digital object identifier (DOI).
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .