no Specific Clincal Condition Required (Focus is on Persons Who Are Feeling Stressed or Want to Improve Their Wellbeing) Clinical Trial
Official title:
Micro-interventions Aiming to Optimize Expectations or Self-compassiong and Their Differential Effects
| Verified date | July 2020 |
| Source | Philipps University Marburg Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The study's aim is to determine whether brief interventions (micro-interventions) aiming to optimize expectations or enhancing feelings of self-compassion are able to improve well-being/reduce perceived stress in comparison to an active control group in an online-study
| Status | Recruiting |
| Enrollment | 179 |
| Est. completion date | August 15, 2020 |
| Est. primary completion date | August 15, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Philipps University Marburg | Marburg | Hessen |
| Lead Sponsor | Collaborator |
|---|---|
| Philipps University Marburg Medical Center |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in perceived stress ratings | 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) | |
| Secondary | Change in perceived (stress) burden ratings (resulting from perceived stress) | 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) | |
| Secondary | Change in emotions (PANAS) | 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) | |
| Secondary | Change in state optimism ratings | 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) | |
| Secondary | Change in state self-compassion | 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) | |
| Secondary | Satisfaction ratings with the respective intervention | 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) | |
| Secondary | Ratings directly assessing the perceived change due to the intervention | 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) | |
| Secondary | Change in perceived self-efficacy (expectations) | 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) | |
| Secondary | Change in anxiety and depression state (STADI) | 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) |