NCT04786496|Completed
Wise Interventions and Responses to Stress
ITP-RSA
Effects of Wise Interventions in Psychophysiological Responses to Stress
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ITP-RSA
Effects of Wise Interventions in Psychophysiological Responses to Stress
Sponsor study identifier
interventional
107
1 country
1
Study Start
September 1, 2019
Actual (reported)Primary Completion
February 21, 2020
Actual (reported)Study Completion
February 21, 2020
Actual (reported)This study compares the effects of two wise interventions (implicit theory of personality intervention and implicit theory of personality intervention plus self-affirmation) with a control condition in the stress responses of young adults. Responses include respiratory sinus arrhythmia, heart rate, skin conductance level, cortisol levels, and mood.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 21, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2019
Actual (reported)February 21, 2020
Actual (reported)February 21, 2020
Actual (reported)February 25, 2021
Actual (reported)March 8, 2021
Actual (reported)Change from baseline levels of cortisol in saliva at recovery (immediately after the procedure -Trier Social Stress Task-).
Participants provided saliva samples to be assayed for neuroendocrine levels to measure cortisol. They were directed to transfer saliva from their mouths to a tube. The sample tubes were carefully labelled and stored in a freezer at -25 ºC until they were sent to the Medikosta Laboratory.
Baseline and immediately after the math phase of the Trier Social Stress Task.
Change from baseline levels of heart-rate (HR) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).
Electrocardiogram (ECG) to measure heart-rate (HR) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
Wise intervention (based on ITP and SA) consisting on several tasks to be completed individually. 30 minutes
Wise intervention (based on ITP) consisting on several tasks to be completed individually. 30 minutes
Intervention designed to promote well-being and resilience in late adolescents and young adults. It includes two components: a self-affirmation (SA) activity and an ITP intervention. The SA component includes a list of values so that they could choose the three most important for them. Next, they are asked to write why those selected values are the most important to them. The ITP component resembled the intervention developed by David S. Yeager and colleagues and it was adapted to first year university students. It consisted of three parts. First, participants are asked to read scientific studies that provide evidence that behaviors are controlled pathways in the brain that have the potential to be changed under the right circumstances. Second, participants read several testimonials purportedly written by second year university students to bring credibility to the ITP. Finally, participants are asked to write their own version of such a narrative (self-persuasive writing exercise).
University of Deusto
Bilbao, Vizcaya, 48003, Spain
Esther Calvete, PhD
University of Deusto
107 participants (actual enrollment reported by the registry).
Breath, Stress and Health: a Biocultural Study of Hatha Yoga Practice
Change from baseline levels of heart-rate variability (HRV) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).
Electrocardiogram (ECG) to measure heart-rate variability (HRV) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
Change from baseline levels of skin conductance level (SCL) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).
Electrodermal Activity to measure skin conductance level (SCL) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
Change from baseline scores of the subscale for Negative Mood of the Scale for Mood Assessment (Sanz, 2001) at recovery (immediately after the procedure -Trier Social Stress Task-).
Self reported transitory negative moods measured by 12 items (assessing depression, anxiety, and hostility) scored on an 11-point scale from 0 (nothing) to 10 (a lot), yielding a total between 0 and 120 (with higher scores meaning higher negative moods).
Baseline and immediately after the math phase of the Trier Social Stress Task.
Change from baseline scores of the subscale for Positive Mood of the Scale for Mood Assessment (Sanz, 2001) at recovery (immediately after the procedure -Trier Social Stress Task-).
Self reported transitory positive mood measured by 4 items (assessing elation) scored on an 11-point scale from 0 (nothing) to 10 (a lot), yielding a total between 0 and 40 (with higher scores meaning higher positive mood).
Baseline and immediately after the math phase of the Trier Social Stress Task.
Educational intervention (about heritage conservation) consisting on several tasks to be completed individually. 30 minutes
Intervention designed to promote well-being and resilience in late adolescents and young adults based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection. It includes the ITP component described above for the ITP+SA Wise intervention.
The control intervention was designed to have a similar structure than the experimental interventions, including also reading and writing tasks, but that they were not in any way related to the contents of the experimental interventions. In particular, participants were asked to read an article about the fire that took place in the Notre Dame cathedral in Paris that had been recently published in a newspaper. Starting from the accident of the Notre Dame cathedral, the article focuses on reflecting on the problem of heritage conservation and analyzing the situation of other important cathedrals. After reading the article, the participants were asked to write a few lines evaluating in their opinion the importance of the conservation of historical buildings such as those mentioned and how much of the public economic budget should be used for heritage conservation.
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First Submitted
February 25, 2021
First Posted
March 8, 2021
Study Start
September 1, 2019
Actual (reported)Primary Completion
February 21, 2020
Actual (reported)Study Completion
February 21, 2020
Actual (reported)Last Updated
March 8, 2021
Record last verified: 2021-03
Raw data will be available at OSF when the results of the study are published.
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Source: ClinicalTrials.gov.
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