Trial Outcomes & Findings for Emotion Regulation and Emotion Perception (NCT NCT03790878)
NCT ID: NCT03790878
Last Updated: 2021-02-24
Results Overview
Emotion perception is measured by a computer-based behavioral assessment during the laboratory session. Scores for negative emotional expressions range from 0-100%, with higher scores indicating greater emotion perception accuracy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
During the laboratory experiment (week 1)
Results posted on
2021-02-24
Participant Flow
11 participants were considered screen failures
Participant milestones
| Measure |
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.
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress
|
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.
Habituation: An exposure procedure that reduces emotional distress through habituation
|
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.
Control: No emotion regulation intervention, placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
27
|
|
Overall Study
COMPLETED
|
26
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Emotion Regulation and Emotion Perception
Baseline characteristics by cohort
| Measure |
Mindful Breathing
n=26 Participants
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.
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress
|
Habituation
n=27 Participants
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.
Habituation: An exposure procedure that reduces emotional distress through habituation
|
Control
n=27 Participants
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.
Control: No emotion regulation intervention, placebo
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.56 years
STANDARD_DEVIATION 7.56 • n=5 Participants
|
23.77 years
STANDARD_DEVIATION 7.03 • n=7 Participants
|
23.77 years
STANDARD_DEVIATION 20 • n=5 Participants
|
25 years
STANDARD_DEVIATION 6.77 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
80 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During the laboratory experiment (week 1)Population: Baseline data for one participant was not completed appropriately and was omitted from the analysis.
Emotion perception is measured by a computer-based behavioral assessment during the laboratory session. Scores for negative emotional expressions range from 0-100%, with higher scores indicating greater emotion perception accuracy.
Outcome measures
| Measure |
Mindful Breathing
n=25 Participants
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.
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress
|
Habituation
n=27 Participants
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.
Habituation: An exposure procedure that reduces emotional distress through habituation
|
Control
n=27 Participants
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.
Control: No emotion regulation intervention, placebo
|
|---|---|---|---|
|
The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment
|
77.31 Percent of correct responses
Standard Deviation 14.36
|
81.93 Percent of correct responses
Standard Deviation 17.94
|
84.85 Percent of correct responses
Standard Deviation 16
|
PRIMARY outcome
Timeframe: After the one week of phone-based interventionPerception 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 ratings of emotional valence range from 0-9, with higher scores as more positive emotional valence and lower scores as more negative emotional valence.
Outcome measures
| Measure |
Mindful Breathing
n=26 Participants
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.
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress
|
Habituation
n=27 Participants
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.
Habituation: An exposure procedure that reduces emotional distress through habituation
|
Control
n=27 Participants
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.
Control: No emotion regulation intervention, placebo
|
|---|---|---|---|
|
Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment
|
5.19 units on a scale
Standard Deviation 2.57
|
5.3 units on a scale
Standard Deviation 2.54
|
5.23 units on a scale
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: Beginning of Week one laboratory experiment, End of Week one laboratory experimentSUDS are measured on a 10-point Likert self-report scale of Subjective Units of Distress, ranging from 0-9. Scores are changes in SUDS ratings from before hearing the tone to after the tone, with greater scores indicating greater reductions in distress (positive outcomes). SUDS score was evaluated at the beginning of the laboratory experiment, and then at the very end of the lab experiment. The change score was calculated by subtracting the beginning score from the end score.
Outcome measures
| Measure |
Mindful Breathing
n=26 Participants
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.
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress
|
Habituation
n=27 Participants
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.
Habituation: An exposure procedure that reduces emotional distress through habituation
|
Control
n=27 Participants
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.
Control: No emotion regulation intervention, placebo
|
|---|---|---|---|
|
Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS)
|
1.14 units on a scale
Standard Deviation 1.21
|
0.61 units on a scale
Standard Deviation 0.9
|
0.56 units on a scale
Standard Deviation 0.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Laboratory assessment, up to one weekChanges 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.
Outcome measures
Outcome data not reported
Adverse Events
Mindful Breathing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Habituation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place