- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04461548
Micro-interventions Aiming to Optimize Expectations or Self-compassion to Improve Well-being/Reduce Stress and Their Differential Effects
Micro-interventions Aiming to Optimize Expectations or Self-compassiong and Their Differential Effects
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Hessen
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Marburg, Hessen, Германия, 35032
- Рекрутинг
- Philipps University Marburg
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Контакт:
- Stefan Salzmann, PhD
- Номер телефона: +49 6421-2823350
- Электронная почта: stefan.salzmann@staff.uni-marburg.de
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Контакт:
- Winfried Rief, Professor
- Номер телефона: +49 6421 28 23657
- Электронная почта: rief@staff.uni-marburg.de
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- fluent in German language
- access to a computer/tablet/smartphone with audio output/headphones
Exclusion Criteria:
- not willing to take part in an online-intervention (duration: 60 minutes)
- no access to a computer/tablet/smartphone with audio output/headphones
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: Experimental group 1: Best Possible Self
Participants are asked to think and write about their best possible future self and to imagine this positive future subsequently.
|
All participants are asked to take some time to think and write about the content of the respective intervention group.
After the writing exercise (approx.
15-20 min) participants are asked to imagine that content for about 5 minutes.
|
Экспериментальный: Experimental group 2: Best Possible Self + next steps
Participants are asked to think and write about their best possible future self and what the next steps could be to reach that best possible future.
Subsequently, participants are asked to imagine this positive future.
|
All participants are asked to take some time to think and write about the content of the respective intervention group.
After the writing exercise (approx.
15-20 min) participants are asked to imagine that content for about 5 minutes.
|
Экспериментальный: Experimental group 3: Self-compassion
Participants are asked to think and write about a self-compassion exercise and to imagine this content subsequently.
|
All participants are asked to take some time to think and write about the content of the respective intervention group.
After the writing exercise (approx.
15-20 min) participants are asked to imagine that content for about 5 minutes.
|
Активный компаратор: Active control group
Participants are asked to think and write about a neutral task that is comparable to the experimental groups.
|
All participants are asked to take some time to think and write about the content of the respective intervention group.
After the writing exercise (approx.
15-20 min) participants are asked to imagine that content for about 5 minutes.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change in perceived stress ratings
Временное ограничение: Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Participants are asked to rate how stressed they feel at the moment at two time points (baseline and the intervention) on a questionnaire (VAS: item ranges from 0 (not stressed at all) - 100 (very stressed). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate). e.g.Lesage, F.-X., Berjot, S., & Deschamps, F. (2012). Clinical stress assessment using a visual ana-logue scale. Occupational Medicine, 62(8), 600-605. https://doi.org/10.1093/occmed/kqs140 |
Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change in perceived (stress) burden ratings (resulting from perceived stress)
Временное ограничение: Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Participants are asked to rate how burdened they feel at the moment at two time points (baseline and the intervention) due to the experienced stress on a questionnaire (VAS: item ranges from 0 (not at all) - 100 (very much).
Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).
Indirect/opposite measure of well-being.
|
Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Change in emotions (PANAS)
Временное ограничение: Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate). Krohne, H.W., Egloff, B., Kohlmann, C.W., & Tausch, A. (1996). Experiments with a German version of the "Positive and Negative Affect Schedule (PANAS). Diagnostica, 42, 139-156. |
Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Change in state optimism ratings
Временное ограничение: Change from pre (baseline) to post scores (approx. 30 minutes later)
|
State Optimism measure (SOM), 7 items (each item 1(strongly disagree)-5(strongly agree)).
Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate).
Millstein, R. A., Chung, W. J., Hoeppner, B. B., Boehm, J. K., Legler, S. R., Mastromauro, C. A., & Huffman, J. C. (2019).
Development of the State Optimism Measure.
General hospital psychiatry, 58, 83-93
|
Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Change in state self-compassion
Временное ограничение: Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Change in state self-compassion (SCS-state), 16 items (each item 1(strongly disagree) - 5 (strongly agree)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate). Breines, J. G., & Chen, S. (2013). Activating the inner caregiver: The role of support-giving schemas in increasing state self-compassion. Journal of Experimental Social Psychology, 49(1), 58-64. https://doi.org/10.1016/j.jesp.2012.07.015 |
Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Satisfaction ratings with the respective intervention
Временное ограничение: Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
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e.g.
"I was satisfied with the intervention" or "I feel like I had a benefit from this intervention"
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Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
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Ratings directly assessing the perceived change due to the intervention
Временное ограничение: Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
|
e.g.
"The intervention reduced my perceived stress", "The intervention increased my feeling of being able to influence things"
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Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
|
Change in perceived self-efficacy (expectations)
Временное ограничение: Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Change in perceived self-efficacy (SWE), 10 items (each item (1(not at all) - 4(exactly)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate). SchwarzerR& Jerusalem M. Generalized Self---Efficacy scale. In J. Weinman, S. Wright, &M. Johnston, Measures in health psychology: A user's portfolio. Causal andcontrol beliefs (pp. 35---37). 1995. Windsor, England: NFER---NELSON. |
Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Change in anxiety and depression state (STADI)
Временное ограничение: Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Change in anxiety and depression state (STADI), 20 items (each item 1(strongly disagree) - 4 (strongly agree)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate). Laux, L., Hock, M., Bergner-Köther, R., Hodapp, V., & Renner, K. H. (2013). The State-Trait-Anxiety-Depression-Inventory-Manual. Göttingen, Germany: Hogrefe. |
Change from pre (baseline) to post scores (approx. 30 minutes later)
|
Соавторы и исследователи
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
Другие идентификационные номера исследования
- Micro_expect_compass
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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