- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07589621
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns: A Randomized Clinical Trial of Digital Interventions
The current study aims to explore the efficacy of a text message based safety behavior fading intervention compared to a progressive muscle relaxation intervention for appearance concerns.
Обзор исследования
Статус
Условия
Подробное описание
Appearance-related safety behavior fading intervention procedures will follow methodology previously used in the Cougle Lab. The safety behavior fading intervention is designed to target a decrease or elimination of appearance-related safety behaviors. Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed appearance-related safety behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day. The daily reminder will include the following language: "Hi! This is a friendly reminder to avoid using your checklist behaviors. Please tap the link below to access today's checklist: [link to checklist]." Text messages will be delivered using EZtexting a text messaging platform used for research and marketing. Note that no identifying information will be included in this platform. Each participants phone number will be accompanied with a anonymized ID code. Individuals randomly assigned to the progressive muscle relaxation condition will be instructed to try and practice it daily for the 28 days. They will also receive daily text messages to remind them to practice relaxation and they can log which of the 10 different muscle groups they tensed and released in the past day.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Florida
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Tallahassee, Florida, Соединенные Штаты, 32308
- Florida State University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- being between the ages of 18 and 65 years old
- having an internet-capable smart-phone
- scoring at or above the empirical cutoff for appearance concerns measured by the Social Appearance Anxiety Scale (i.e., 52)
Exclusion Criteria:
- changes in psychotropic medication in the last 4 weeks
- failing attention checks in baseline data collection
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: Safety Behavior Fading
Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed appearance-related safety behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they engaged in each safety behavior over the previous day. |
Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.
Другие имена:
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Активный компаратор: Progressive Muscle Relaxation
Participants in this condition will be instructed to try and practice progressive muscle relaxation daily for 28 days. To match safety behavior fading they will also receive daily text messages to remind them to practice relaxation and they can log which of the 10 different muscle groups they tensed and released in the past day. |
Participants are asked to practice relaxation daily via text message reminder and checklists to monitor progress. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The Social Appearance Anxiety Scale (SAAS)
Временное ограничение: Day 0, Day 28, Day 56
|
Self-report scale that measures appearance anxiety symptoms. Scores range from 16 to 80 with higher scores indicating higher levels of appearance concerns. |
Day 0, Day 28, Day 56
|
|
Appearance Behaviors Checklist past-week version (author constructed)
Временное ограничение: Day 0, Day 28, Day 56
|
Self-report scale used to measure frequency of engaging in appearance-related safety behaviors. This scale will be used as a manipulation check. Each item is rated on a 0 to 10 scale. Total scores range from 0 to 130 with higher scores indicating greater engagement in appearance-related safety behaviors |
Day 0, Day 28, Day 56
|
|
Appearance Anxiety Inventory (AAI; Veale et al., 2014)
Временное ограничение: Day 0, Day 28, Day 56
|
Self-report scale that measures of body dysmorphic symptoms. Scores range from 0 to 40 with higher scores indicating higher levels of body dysmorphic symptoms. |
Day 0, Day 28, Day 56
|
|
Social Phobia Inventory (SPIN; Connor et al., 2000)
Временное ограничение: Day 0, Day 28, Day 56
|
Self-report scale that measures social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety. |
Day 0, Day 28, Day 56
|
|
Eating Disorder-15 (ED-15; Tatham et al., 2015).
Временное ограничение: Day 0, Day 28, Day 56
|
Self-report scale that measures eating disorder symptoms. Scores range from 0 to 90 with higher scores indicating higher levels of eating pathology. |
Day 0, Day 28, Day 56
|
|
The Eating Disorder Inventory-Body Dissatisfaction (EDI; Garner et al., 1983).
Временное ограничение: Day 0, Day 28, Day 56
|
Self-report scale for measuring body dissatisfaction for use in clinical outcome studies. Each item is rated on a 0-5 scale with a total score range of 9-54 with higher scores indicating greater drive for thinness, bulimia, and body dissatisfaction. |
Day 0, Day 28, Day 56
|
|
Credibility and Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).
Временное ограничение: Day 0
|
Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Three items are rated on a 0-10 scale and one item is rated on a 0-100 scale with higher scores meaning greater expectancy and credibility. |
Day 0
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)
Временное ограничение: Day 0, Day 28, Day 56
|
Self-report measure of depression symptom severity. Each item is rated on a 0 to 3 scale. Total scores range from 0 to 30 with higher scores indicating greater depression severity. |
Day 0, Day 28, Day 56
|
|
Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
Временное ограничение: Day 0, Day 28, Day 56
|
Self-report measure of anxiety symptom severity. Each item is rated on a 0 to 3 scale. Total scores range from 0 to 28 with higher scores indicating greater anxiety severity. |
Day 0, Day 28, Day 56
|
|
Appearance Preference Task
Временное ограничение: Day 0, Day 28, Day 56
|
Computerized forced-choice task measuring appearance importance relative to other favorable characteristics. The APT randomly presents a series of 33 word pairs and asks the participant to select the concept that is more important to them. Each pair consists of a positive appearance-related adjective and a positive character trait unrelated to appearance (e.g., beautiful-responsible). Higher scores indicate greater endorsement of appearance words. |
Day 0, Day 28, Day 56
|
|
Social Interaction Scale (Author Constructed)
Временное ограничение: Day 0, Day 28, Day 56
|
Single-item self-report scale that the extent to which individuals engage with their social support networks. This question asks: "what percentage of your time awake did you spend interacting with others this past week (0% =No time at all, 100% =all of the time)?" |
Day 0, Day 28, Day 56
|
|
Body Dysmorphic Disorder Symptom Scale-Cognitive Subscale (Wilhelm et al., 2016)
Временное ограничение: Day 0, Day 28, Day 56
|
Self-report scale that measures cognitions related to body dysmorphic disorder. Scores range from 0 to 190 with higher scores indicating higher levels of maladaptive cognitions related to body dysmorphic disorder. |
Day 0, Day 28, Day 56
|
Соавторы и исследователи
Спонсор
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
Дополнительные соответствующие термины MeSH
- Психические расстройства
- Признаки и симптомы, пищеварительный тракт
- Фобические расстройства
- Тревожные расстройства
- Соматоформные расстройства
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Фобия, Социальные
- Кормление и расстройства пищевого поведения
- Дисморфические расстройства тела
- Терапия
- Терапия разума и тела
- Дополнительная терапия
- Психотерапия
- Поведенческие дисциплины и деятельность
- Гипноз
- Автогенная тренировка
Другие идентификационные номера исследования
- STUDY00007433
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. .