- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Hessen
-
Marburg, Hessen, Niemcy, 35032
- Rekrutacyjny
- Philipps University Marburg
-
Kontakt:
- Stefan Salzmann, PhD
- Numer telefonu: +49 6421-2823350
- E-mail: stefan.salzmann@staff.uni-marburg.de
-
Kontakt:
- Winfried Rief, Professor
- Numer telefonu: +49 6421 28 23657
- E-mail: rief@staff.uni-marburg.de
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: 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.
|
Eksperymentalny: 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.
|
Eksperymentalny: 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.
|
Aktywny komparator: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change in perceived stress ratings
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change in perceived (stress) burden ratings (resulting from perceived stress)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
|
e.g.
"I was satisfied with the intervention" or "I feel like I had a benefit from this intervention"
|
Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
|
Ratings directly assessing the perceived change due to the intervention
Ramy czasowe: 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"
|
Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
|
Change in perceived self-efficacy (expectations)
Ramy czasowe: 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)
Ramy czasowe: 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)
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- Micro_expect_compass
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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