Emotion Regulation and Emotion Perception (EREP)
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|ClinicalTrials.gov Identifier: NCT03790878|
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Emotions||Behavioral: Mindful Breathing Behavioral: Habituation Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Evaluating the Impact of an Emotion Regulation Intervention on Emotion Perception|
|Actual Study Start Date :||February 4, 2019|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Experimental: Mindful Breathing
Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.
Behavioral: Mindful Breathing
Training in a mindful breathing skill that reduces emotional distress
Active Comparator: Habituation
Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.
An exposure procedure that reduces emotional distress through habituation
Placebo Comparator: Control
Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.
No emotion regulation intervention, placebo
- The ability to perceive negative and positive emotional expressions, as measured by a behavioral computer-based assessment [ Time Frame: Laboratory assessment, up to one week ]Emotion perception is measured by a computer-based behavioral assessment during the laboratory session. Scores for negative emotional expressions and positive emotional expressions range from 0-30, with higher scores indicating greater emotion perception accuracy.
- Changes in emotion perception, as measured by a phone-based behavioral assessment [ Time Frame: 7 days ]Perception of positive emotional expressions and negative emotional expressions are measured by a behavioral phone-based assessment, delivered multiple times over one week via mobile phones. Scores for negative emotional expressions and positive emotional expressions range from 0-21, with higher scores indicating greater emotion perception accuracy.
- Emotional distress, as measured by Subjective Units of Distress (SUDS) [ Time Frame: Laboratory assessment, up to one week ]Scores are measured on a 10-point Likert self-report scale of Subjective Units of Distress (SUDS), ranging from 0-9 with higher scores indicating higher emotional distress (worse outcome).
- Changes in emotional arousal, as measured by skin conductance response (SCR) [ Time Frame: Laboratory assessment, up to one week ]Changes in emotional arousal are measured physiologically with electrodermal activity. Skin conductance response measures phasic changes in electrical conductivity of skin, with a minimum threshold of 0.01μS with higher values indicating greater changes in emotional arousal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790878
|Contact: Kibby McMahon, MA||919-684-9952||Kibby.McMahon@duke.edu|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Katherine L McMahon, MA 917-880-1551 Kibby.McMahon@duke.edu|
|Contact: Mark Z Rosenthal, PhD Mark.Rosenthal@duke.edu|
|Principal Investigator:||Mark Z Rosenthal, PhD||Duke University|