- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03989518
The Link Between Mental Imagery and the Reduction of Fear in Imaginal Extinction
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The study takes part over three consecutive days, with fear conditioning to visual stimuli on day 1, imaginal extinction on day 2, and a fear reinstatement procedure, again to visual stimuli, on day 3. Skin conductance is used to measure fear responses.
Participants' are randomized to receive conditioning, extinction and reinstatement with either complex or simple stimuli. During imaginal extinction, imagery of each experimental stimulus is prompted through different verbal instructions.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Uppsala, Швеция
- Uppsala University, Departement of Psychology
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Age 18 or over
Fluent in Swedish
Willing and able to provide informed consent and complete study procedures
Exclusion Criteria:
Current psychiatric disorder
Use of psychotropic medication within 6 months prior to study start
Receiving psychological treatment within 6 months prior to study start
Current neurological condition
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Simple stimuli
Two perceptually simple stimuli are used during all experimental phases (geometrical figures).
|
Day 1. Participants are exposed to two different visual stimuli.
One of these stimuli is paired with a mild electric shock (i.e.
conditioned stimuli).
Day 2 (24 hours after Day 1).
Participants are exposed to mental imagery of the stimuli used during fear conditioning.
Imagery is prompted through different verbal instructions presented in a pseudo-randomized order.
No shocks are delivered.
Prior to imaginal extinction, participants receive task specific training.
Day 3 (48 h after day1).
Participants are exposed to the same stimuli used during fear conditioning (day 1) and imaginal extinction (day 2).
Two unsignaled shocks are delivered at the beginning of the experiment, prior to the presentation of the first visual stimulus.
No further shocks are delivered.
This procedure allows the study of long term effects of imaginal extinction.
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Экспериментальный: Complex stimuli
Two complex stimuli are used in all experimental phases.
Stimuli consist of photographs of real objects of the same size and shape as the simple stimuli, but include perceptually more complex patterns, details and colors.
|
Day 1. Participants are exposed to two different visual stimuli.
One of these stimuli is paired with a mild electric shock (i.e.
conditioned stimuli).
Day 2 (24 hours after Day 1).
Participants are exposed to mental imagery of the stimuli used during fear conditioning.
Imagery is prompted through different verbal instructions presented in a pseudo-randomized order.
No shocks are delivered.
Prior to imaginal extinction, participants receive task specific training.
Day 3 (48 h after day1).
Participants are exposed to the same stimuli used during fear conditioning (day 1) and imaginal extinction (day 2).
Two unsignaled shocks are delivered at the beginning of the experiment, prior to the presentation of the first visual stimulus.
No further shocks are delivered.
This procedure allows the study of long term effects of imaginal extinction.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Skin conductance response (SCR)
Временное ограничение: Day 1
|
SCR is used as a measure of physiological fear responses.
Differences in fear responses are used to assess fear learning during fear acquisition and to explore main effects and interactions between fear learning, stimulus complexity and capacity for mental imagery.
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Day 1
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Skin conductance response (SCR)
Временное ограничение: Day 2 (24 h after day1)
|
SCR is used as a measure of physiological fear responses.Differences in fear responses are used to assess fear reduction during imaginal extinction, and to explore main effects and interactions between fear reduction, stimulus complexity and capacity for mental imagery.
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Day 2 (24 h after day1)
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Skin conductance response (SCR)
Временное ограничение: Day 3 (48 h after day 1)
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SCR is used as a measure of physiological fear responses.Differences in fear response are used to assess return of fear during reinstatement, and to explore main effects and interactions between return of fear, stimulus complexity and capacity for mental imagery.
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Day 3 (48 h after day 1)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Fear ratings
Временное ограничение: Day 1
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Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
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Day 1
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State-Trait Anxiety Inventory
Временное ограничение: Day 1
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This is a self-rated questionnaire measuring trait anxiety.
Higher scores indicate higher level of trait-anxiety (range 20-80)
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Day 1
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Difficulties in emotion regulation scale
Временное ограничение: Day 1
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This is a self-rated questionnaire measuring difficulties in emotion regulation.
Higher scores indicate higher level of difficulties in emotion regulation (range 36-180)
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Day 1
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Fear ratings
Временное ограничение: Day 2 (24 h after day 1)
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Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
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Day 2 (24 h after day 1)
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Vividness of mental imagery during imaginal extinction
Временное ограничение: Day 2 (24 h after day 1)
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Scale: 1-5; no image at all - image as clear and vivid as real life
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Day 2 (24 h after day 1)
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The Plymouth Sensory Imagery Questionnaire
Временное ограничение: Day 2 (24 h after day 1)
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This is a self-rated questionnaire measuring vividness of mental imagery across different sensory modalities.
Higher scores indicate higher level of vividness.
(range 0-70)
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Day 2 (24 h after day 1)
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The Vividness of Visual Imagery Questionnaire
Временное ограничение: Day 2 (24 h after day 1)
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This is a self-rated questionnaire measuring vividness of visual mental imagery.
Only eyes open section is administered.
Higher scores indicate higher level of vividness (range 0-80)
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Day 2 (24 h after day 1)
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Spontaneous use of imagery scale
Временное ограничение: Day 2 (24 h after day 1)
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This is a self-rated questionnaire measuring spontaneous use of imagery.
Higher scores higher levels use of spontaneous use of imagery (range 12- 60)
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Day 2 (24 h after day 1)
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Expectancy ratings
Временное ограничение: Day 2 (24 h after day 1)
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After the imaginal extinction procedure, participants are asked to rate to what extent they believed that electric shocks would be delivered during the procedure on a scale ranging from 0 - 100 %
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Day 2 (24 h after day 1)
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Fear ratings
Временное ограничение: Day 3 (48 h after day 1)
|
Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
|
Day 3 (48 h after day 1)
|
Expectancy ratings
Временное ограничение: Day 3 (48 h after day 1)
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After the reinstatement procedure, participants are asked to rate to what extent they believed that electric shocks would be delivered during the procedure on a scale ranging from 0 - 100 %
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Day 3 (48 h after day 1)
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Task compliance
Временное ограничение: Day 1
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Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
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Day 1
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Task compliance
Временное ограничение: Day 2 (24 h after day 1)
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Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
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Day 2 (24 h after day 1)
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Task compliance
Временное ограничение: Day 3 (48 h after day 1)
|
Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
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Day 3 (48 h after day 1)
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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
Другие идентификационные номера исследования
- 2019-00524
Планирование данных отдельных участников (IPD)
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Сроки обмена IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- МКФ
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. .
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