Мобильное медицинское вмешательство для улучшения психосоциального функционирования ветеранов с посттравматическим стрессовым расстройством и симптомами депрессии
Posttraumatic stress disorder (PTSD) and depression are the two most common mental health conditions among Veterans. When Veterans experience both, there is a negative impact on their functioning, making it difficult to function at work or at home and socially with other people. Although talk therapies can result in improvements in functioning, they are difficult to access because there are limited clinicians who can provide them. As most US adults now own a smartphone, mobile apps are a way for Veterans to access content traditionally delivered through talk therapies at their own pace. This study will test a mobile app based on a trauma-informed talk therapy that has helped Veterans with PTSD and depression make large improvements in functioning, through learning skills to navigate emotions and relationships. Additionally, through answering brief surveys and enabling passive tracking on their smartphones, Veterans will see real-time information on their functioning and mental health and on potential benefits from using these skills.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Veterans experience high rates of posttraumatic stress disorder (PTSD) and depression, which are frequently comorbid and result in difficulties with psychosocial functioning substantially greater than either disorder alone. Functioning difficulties in Veterans have not been adequately addressed by most existing psychotherapies for PTSD and depression because they often focus on symptom improvement and are highly resource-intensive, requiring the training and time of skilled providers. To address this gap, mobile health (mHealth) apps can serve as a widely accessible, standalone or adjunctive intervention to target psychosocial functioning among Veterans with comorbid PTSD and depression. This study focuses on the evaluation of a self-guided mHealth intervention based on Skills Training in Affective and Interpersonal Regulation (STAIR), an evidence-based psychotherapy that explicitly targets functioning improvements and also alleviates PTSD and depression symptoms among trauma survivors. As part of the intervention, real-time assessment (i.e., ecological momentary assessment and passive sensing) will be incorporated to support Veterans in monitoring their functioning, symptoms, and potential benefits from STAIR. The primary goal is to determine the feasibility and acceptability of this intervention (self-guided STAIR Coach with real-time assessment).
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Haijing W Hallenbeck, PhD MA
- Номер телефона: (650) 387-4116
- Электронная почта: haijing.hallenbeck@va.gov
Места учебы
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California
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Palo Alto, California, Соединенные Штаты, 94304-1207
- VA Palo Alto Health Care System, Palo Alto, CA
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Контакт:
- Haijing W Hallenbeck, PhD MA
- Номер телефона: (650) 387-4116
- Электронная почта: haijing.hallenbeck@va.gov
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Главный следователь:
- Haijing Wu Hallenbeck, PhD MA
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Veteran
- enrolled in VA care
- fluent in English
- able to provide informed consent
- own a smartphone or willing to use a study-provided smartphone
- have diagnoses of current posttraumatic stress disorder (PTSD) and major depressive disorder (MDD)
- willing to not begin another form of Skills Training in Affective and Interpersonal Regulation (STAIR) during the study
Exclusion Criteria:
- history of mania or psychosis
- current suicidal ideation with plan and intent to harm self
- acute intoxication from alcohol or other substances
- current or past experience with any form of STAIR
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Self-Guided STAIR Coach with Real-Time Assessment
Participants randomized to this condition will receive two mobile apps. |
Two mobile apps to be used as one intervention package to support participants in their progress through STAIR (Skills Training in Affective and Interpersonal Regulation) with self-monitoring of symptoms and functioning |
|
Активный компаратор: Real-Time Assessment
Participants randomized to this condition will receive one mobile app. |
One mobile app to support participants in self-monitoring of symptoms and functioning |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Study Recruitment Rate
Временное ограничение: Evaluated at end of trial (lasting approximately 2 years)
|
Recruitment rate will be calculated as the number of participants who are eligible for the study divided by the number of screened participants. Target feasibility benchmark is 50%. |
Evaluated at end of trial (lasting approximately 2 years)
|
|
Study Retention Rate
Временное ограничение: Evaluated at end of trial (lasting approximately 2 years)
|
Retention rate will be calculated as the number of participants who completed the full study divided by the total number of enrolled participants. Target feasibility benchmark is 70%. |
Evaluated at end of trial (lasting approximately 2 years)
|
|
Study Engagement Rate
Временное ограничение: Evaluated at end of trial (lasting approximately 2 years)
|
Engagement rate will refer to the mean percentage of completed STAIR Coach training plan levels and completed EMA surveys. Target feasibility benchmark is 70%. |
Evaluated at end of trial (lasting approximately 2 years)
|
|
Mobile Application Rating Scale User Version (uMARS)
Временное ограничение: Post-treatment (i.e., 12 weeks after starting the trial)
|
App quality will be assessed through the Mobile Application Rating Scale User Version (uMARS). Total scores on the uMARS range from 1 to 5, with higher scores indicating higher quality. Target acceptability benchmark is a uMARS mean score of greater than or equal to 4 (indicating positive app quality). |
Post-treatment (i.e., 12 weeks after starting the trial)
|
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Client Satisfaction Questionnaire-8 (CSQ-8)
Временное ограничение: Post-treatment (i.e., 12 weeks after starting the trial)
|
Client satisfaction will be assessed through the Client Satisfaction Questionnaire-8 (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, with higher scores indicating higher satisfaction. Acceptability benchmark is a CSQ-8 mean score of greater than or equal to 24 (indicating general treatment satisfaction). |
Post-treatment (i.e., 12 weeks after starting the trial)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Временное ограничение: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
|
PTSD symptoms will be assessed through the PTSD Checklist for DSM-5 (PCL-5). Total scores on the PCL-5 range from 0 to 80, with higher scores indicating greater PTSD symptoms. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition. |
Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
|
|
Patient Health Questionnaire-9 (PHQ-9)
Временное ограничение: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
|
Depression symptoms will be assessed through the Patient Health Questionnaire-9 (PHQ-9). Total scores on the PHQ-9 range from 0 to 27, with higher scores indicating greater depression symptoms. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition. |
Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
|
|
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Временное ограничение: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
|
Psychosocial functioning impairment will be assessed through the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Total scores on the WHODAS 2.0 range from 0 to 144, with higher scores indicating greater functioning impairment. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition. |
Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
|
Соавторы и исследователи
Следователи
- Главный следователь: Haijing Wu Hallenbeck, PhD MA, VA Palo Alto Health Care System, Palo Alto, CA
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- D5318-W
- IK2RX005318-01A1 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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. .