Depression Clinical Trial
— ITP-RSAOfficial title:
Effects of Wise Interventions in Psychophysiological Responses to Stress
NCT number | NCT04786496 |
Other study ID # | ITP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | February 21, 2020 |
Verified date | March 2021 |
Source | University of Deusto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 107 |
Est. completion date | February 21, 2020 |
Est. primary completion date | February 21, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 26 Years |
Eligibility | Inclusion Criteria: - Informed consent by the participants. - To be fluent in Spanish. Exclusion criteria: - Having cardiovascular disease. |
Country | Name | City | State |
---|---|---|---|
Spain | University of Deusto | Bilbao | Vizcaya |
Lead Sponsor | Collaborator |
---|---|
University of Deusto | Basque Country Government, Spanish Government |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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). | |
Primary | 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). | |
Primary | 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). | |
Primary | 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. | |
Primary | 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. |
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