- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04787809
Living Well: A Digital ACT Intervention
Living Well: A Digital Acceptance and Commitment Therapy-Informed Intervention
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Depression and anxiety disorders are among the most prevalent psychological difficulties and contribute to negative economic, social, and health outcomes. As they are frequently comorbid and share underlying mechanisms of dysfunction, many scholars have conceptualized these as a unified category of emotional disorders. Addressing processes contributing to dysfunction among individuals who are at risk for developing emotional disorders has the potential to prevent significant negative impact.
Acceptance and Commitment Therapy (ACT) has received empirical support in the treatment of depression and anxiety in a number of examinations. ACT aims to shape acceptance of challenging thoughts and feelings and engagement with areas of life one finds meaningful and important. The converse of acceptance, experiential avoidance, or the unwillingness to experience unpleasant thoughts and emotions even when doing so is maladaptive, has been predictive of symptoms of depression and anxiety. Reducing experiential avoidance and shaping alternative responses, such as acceptance and behavior consistent with one's values, termed committed action, is a promising strategy for targeting risk for emotional disorders.
Traditional means of delivering interventions fail to reach a substantial proportion of those who struggle with psychological difficulties. Barriers such as distance, time, and cost contribute to these challenges. Digital mental health interventions offer a means to overcome treatment barriers and increase access. These approaches can be delivered in individual's homes at the time of their choosing. Additionally, digital interventions can be delivered to many people at the same time, reducing cost. Support for the impact of ACT-informed digital interventions on symptoms of depression and anxiety has been obtained, suggesting that this framework is promising for reducing risk.
The goal of the current study is to compare the impact of a digital ACT-informed intervention on psychological symptoms and processes of change among individuals at risk for depression and anxiety. The following hypotheses will be evaluated:
- Individuals in the treatment condition will experience a decrease in symptoms of depression and anxiety compared to those in the control group
- Individuals in the treatment condition will experience a decrease in experiential avoidance and increase in values consistent behavior compared to those in the control group
- The digital intervention will generally be rated positively
- The relationship between cognitive fusion and treatment response will be explored
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Texas
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Tyler, Texas, Соединенные Штаты, 75701
- UT Tyler
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Undergraduate students aged 18 or older
- Mildly to moderately elevated symptoms of depression or anxiety as reflected by DASS-21 Depression (5-10) or Anxiety scores (4-7).
Exclusion Criteria:
- Participants under the age of 18
- Severe or extremely severe scores on DASS-21 Depression (11 or greater) or Anxiety (8 or greater).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Living Well Intervention Group
Participants in the Living Well treatment group will receive a brief digital intervention informed by Acceptance and Commitment Therapy.
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Living Well is a single session digital intervention that aims to decrease experiential avoidance and increase engagement in values-consistent behavior.
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Без вмешательства: Control Group
Participants in the control group will not receive any intervention.
These individuals will have the option to access the intervention at the conclusion of their study participation.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Depression Anxiety Stress Scales-21 Depression Scale repeated measure of change
Временное ограничение: pre-intervention, two week post intervention, and four week post intervention
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Depression Anxiety Stress Scales-21 (DASS-21) is a 21 item self report questionnaire assessing symptoms of depression, anxiety, and stress.
The DASS-21 seven item Depression Scale will be used to assess symptoms of depression and with higher scores indicating greater depressive symptoms.
Scores on the DASS-21 Depression Scale range from 0 to 21.
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pre-intervention, two week post intervention, and four week post intervention
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Depression Anxiety Stress Scales-21 Anxiety Scale repeated measure of change
Временное ограничение: pre-intervention, two week post intervention, and four week post intervention
|
Depression Anxiety Stress Scales-21 (DASS-21) is a 21 item self report questionnaire assessing symptoms of depression, anxiety, and stress.
The DASS-21 seven item Anxiety Scale will be used to assess symptoms of anxiety with higher scores indicating greater anxiety symptoms.
Scores on the DASS-21 Anxiety Scale range from 0 to 21.
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pre-intervention, two week post intervention, and four week post intervention
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Brief Experiential Avoidance Questionnaire repeated measure of change
Временное ограничение: pre-intervention, two week post intervention, and four week post intervention
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Brief Experiential Avoidance Questionnaire (BEAQ) is a 15 item self report measure assessing experiential avoidance.
Higher scores on the BEAQ indicate greater experiential avoidance.
Scores on the BEAQ can range from 15 to 90.
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pre-intervention, two week post intervention, and four week post intervention
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Valuing Questionnaire-Progress Scale repeated measure of change
Временное ограничение: pre-intervention, two week post intervention, and four week post intervention
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Valuing Questionnaire-Progress Scale (VQ-P) is a five item scale assessing the extent to which one made progress towards one's values that is a part of the ten item Valuing Questionnaire.
Higher scores on the VQ-P indicate greater progress towards one's values and VQ-P scores can range from 0 to 30.
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pre-intervention, two week post intervention, and four week post intervention
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
COVID-19 Impact Indicators repeated measure of change
Временное ограничение: Measured at baseline, 2 weeks post baseline, and 4 weeks post baseline
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Participants will provide information on how they have been impacted by the COVID-19 pandemic.
They will respond to the question "How has the COVID-19 outbreak affected you in the past two weeks (you can select multiple options)" selecting from among 10 possible options: Diagnosed with COVID-19, worked remotely or from home more than you usually do, worked more hours than usual, worked reduced hours, was not able to work, had difficulty arranging for childcare, incurred increased costs for childcare expenses, income or pay has been reduced, not paid at all, had serious financial problems.
Participants may choose between 0 and 10 possible COVID-19 impacts.
These do not belong to a standardized questionnaire, but have been used by other researchers to describe the impact of COVID-19.
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Measured at baseline, 2 weeks post baseline, and 4 weeks post baseline
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Cognitive Fusion Questionnaire
Временное ограничение: Measured at baseline
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The Cognitive Fusion Questionnaire is a self report measure of cognitive fusion consisting of seven items.
Higher scores indicate greater cognitive fusion and scores can range from 7 to 49.
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Measured at baseline
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Treatment Experience/Perceived Need Questions
Временное ограничение: Measured at baseline
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Participants will respond to three questions about past experience with mental health treatment and perceived future need with yes/no responses. These questions do not belong to a standardized questionnaire, but have been used by other researchers to describe participant experience. In the past 12 months, did you receive therapy from a professional counselor or therapist to help you with emotional or mental health problems such as feeling sad, blue, anxious, or nervous? In the past 12 months, did a healthcare professional prescribe medications to help you with emotional or mental health problems such as feeling sad, blue, anxious, or nervous? In the past 12 months, did you think you needed help for emotional or mental health problems such as feeling sad, blue, anxious, or nervous? |
Measured at baseline
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Olga Berkout, PhD, University of Texas at Tyler
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
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
- IRB-FY2021-74
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.
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 Living Well
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