- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04035577
IntelliCare in College Students (ICCS)
Expanding College Student Mental Health With Stress Management Mobile Technologies - Extended Usability Trial
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60611
- Northwestern University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Participant is a student at the University of Illinois in Chicago or Northern Illinois University. Participant owns a smartphone capable of running Android 7 (or higher) or iOS11 (or higher).
Participant is 18 years of age or older
Exclusion Criteria:
None
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Extended usability of a mobile self-help intervention
Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks
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During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8.
All participants will first undergo initial assessments that will include a series of online questionnaires about their mood.
Eligible participants will receive up to 8 weeks of access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management.
It is suggested that participants utilize the mobile phone tools every day
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
Временное ограничение: Week 4
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The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-8 is 0-24. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-24 is severe. |
Week 4
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Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
Временное ограничение: Week 8
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The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-24. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-24 is severe. |
Week 8
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GAD-7 (Generalized Anxiety Disorder Scale-7)
Временное ограничение: Week 4
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The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity.
GAD-7 total score for the seven items ranges from 0 to 21.
Higher values represent a worse outcome.
Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.
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Week 4
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GAD-7 (Generalized Anxiety Disorder Scale-7)
Временное ограничение: Week 8
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The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity.
GAD-7 total score for the seven items ranges from 0 to 21.
Higher values represent a worse outcome.
Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.
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Week 8
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Anxiety Literacy Questionnaire
Временное ограничение: Week 4
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This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.
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Week 4
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Anxiety Literacy Questionnaire
Временное ограничение: Week 8
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This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.
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Week 8
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Depression Literacy Questionnaire
Временное ограничение: Week 4
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This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy
|
Week 4
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Depression Literacy Questionnaire
Временное ограничение: Week 8
|
This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.")
Participants receive a score of 1 for each statement they correctly assign as either true or false.
Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy
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Week 8
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Cognitive and Behavioral Response to Stress Scale
Временное ограничение: Week 4
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This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills.
There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness.
For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g.
"During the past month, how often did you take a moment to notice things that made you feel good or grateful?
How helpful was this in making you feel better?").
Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30.
Higher scores indicate better outcomes.
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Week 4
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The Cognitive and Behavioral Response to Stress Scale
Временное ограничение: Week 8
|
This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills.
There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness.
For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g.
"During the past month, how often did you take a moment to notice things that made you feel good or grateful?
How helpful was this in making you feel better?").
Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30.
Higher scores indicate better outcomes.
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Week 8
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Mean Number of Treatment App Use Sessions
Временное ограничение: Daily for two months
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Daily for two months
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- K08MH112878-EUT
- K08MH112878 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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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.
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. .
Клинические исследования Mobile self-help intervention
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