- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07577947
Health And Response: Digital Markers for Outcomes in Perinatal Depression Treatment Study (HARMONY)
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Eliza Congdon, PhD
- Номер телефона: (310)-339-9053
- Электронная почта: harmonystudy@mednet.ucla.edu
Места учебы
-
-
California
-
Los Angeles, California, Соединенные Штаты, 90095
- Рекрутинг
- University of California, Los Angeles
-
Главный следователь:
- Nelson Freimer, MD
-
Контакт:
- Eliza Congdon
- Номер телефона: (310)-339-9053
- Электронная почта: harmonystudy@mednet.ucla.edu
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- At least 18 years of age
- Able to read and communicate in English
- Between 28 weeks pregnant and 12 weeks postpartum
- Moderate-to-severe depression, as defined by Edinburgh Postnatal Depression Scale (EPDS) score ≥11
- Not currently seeing a provider for mental health care
- Own functioning iOS smartphone (iPhone 11 or newer, iOS 18 or newer) with access to reliable data plan and Wifi)
- Able to read and understand a written informed consent form
- Willingness to participate in treatment through the study and follow all study procedures, including providing HIPAA Authorization for research, installing a study app on personal iPhone, and wearing the provided Apple Watch for at least 20 hours every day in the first four weeks of the study (including while sleeping)
Exclusion Criteria:
- Currently receiving treatment by a therapist or a psychiatrist
- Unstable suicidality (e.g., 2 or more suicide attempts or self-injurious behaviors resulting in hospitalization in the last 6 months)
- Current substance use disorder that interferes with treatment: specifically, patients meeting diagnostic criteria for Substance Use Disorder (SUD) will be eligible for inclusion only if they are able to attend sessions while not under the influence of that substance, with the exception of individuals abusing opiates or freebase cocaine, who will be excluded
- Principal diagnosis of psychosis unrelated to depression (unipolar or bipolar)
- Neurological conditions
- Severe uncontrolled medical conditions (e.g., anorexia nervosa, cardiac conditions requiring continuous monitoring)
- Cognitive impairment (e.g., developmental disability, dementia)
- Previously participated in the UCLA Depression Grand Challenge "New Moms Mood Tracking & Wellbeing Study" (IRB #20-001924)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Tier 2 - PND Digital Therapy with Coaching
Participants with a recent EPDS score in the moderate range (11-18) and no current suicidality will be given access to a perinatal depression online cognitive-behavioral therapy course (the ParentMood program).
Some of the lesson content is presented as illustrated videos.
Following each lesson, participants can download a document that summarizes the key information in each lesson, and which includes practical homework exercises that reinforce the content of the lesson.
Participants are encouraged to practice their lesson homework for at least one week before starting the next lesson.
Lessons will be completed sequentially.
Participants have the option of accessing the content through a web-browser.
Participants may receive up to 9 coaching sessions with their assigned Coach, in addition to an initial Orientation session, which will occur through secure video conference.
The initial Orientation session is required, but the additional coaching sessions thereafter are optional.
|
Participants with a recent EPDS score in the moderate range (11-18) and no current suicidality will be given access to a perinatal depression online cognitive-behavioral therapy course (the ParentMood program).
Some of the lesson content is presented as illustrated videos.
Following each lesson, participants can download a document that summarizes the key information in each lesson, and which includes practical homework exercises that reinforce the content of the lesson.
Participants are encouraged to practice their lesson homework for at least one week before starting the next lesson.
Lessons will be completed sequentially.
Participants have the option of accessing the content through a web-browser.
Participants may receive up to 9 coaching sessions with their assigned Coach, in addition to an initial Orientation session, which will occur through secure video conference.
The initial Orientation session is required, but the additional coaching sessions thereafter are optional.
|
|
Активный компаратор: Tier 3 - Clinical Care
Participants with a recent EPDS score in the severe range (19-30) and/or significant suicidality with intent or means will be given access to a clinical care, which entails weekly psychotherapy sessions. The number and schedule of psychotherapy sessions in the study is determined by the clinical care team. Treatment appointments will occur through secure video conference. If the clinical team believes that consultation with a psychiatrist is warranted, a referral will be made to a UCLA Health clinic (e.g., the MOMS Clinic) for a consultation session and possible pharmacotherapy. |
Participants with a recent EPDS score in the severe range (19-30) and/or significant suicidality with intent or means will be given access to a clinical care, which entails weekly psychotherapy sessions.
The number and schedule of psychotherapy sessions in the study is determined by the clinical care team.
Treatment appointments will occur through secure video conference.
If the clinical team believes that consultation with a psychiatrist is warranted, a referral will be made to a UCLA Health clinic (e.g., the MOMS Clinic) for a consultation session and possible pharmacotherapy.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Edinburgh Postnatal Depression Scale (EPDS) total score
Временное ограничение: From enrollment through the twelve weeks of the study.
|
Self-reported depression symptom severity scores
|
From enrollment through the twelve weeks of the study.
|
|
Percent change in EPDS scores
Временное ограничение: From enrollment through the twelve weeks of the study.
|
Percent change in self-reported depression symptom severity scores (as measured with EPDS)
|
From enrollment through the twelve weeks of the study.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Treatment retention, as defined by number of coaching or therapy sessions attended by participants
Временное ограничение: From week 2 through week 13 of the study
|
Measure of treatment retention, as defined by number of coaching or therapy sessions attended.
A participant is considered to have been retained in treatment if they completed number of sessions advised by their therapist, or to have not been categorized as dropping from treatment early.
|
From week 2 through week 13 of the study
|
|
Treatment retention, as defined by whether the participant completed treatment or not
Временное ограничение: From week 2 through week 13 of the study
|
Measure of treatment retention, as defined by whether the participant completed treatment or not
|
From week 2 through week 13 of the study
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Michelle G Craske, PhD, University of California, Los Angeles
- Главный следователь: Nelson Freimer, MD, University of California, Los Angeles
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 25-2121
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. .