NCT03790878: EREP

Emotion Regulation and Emotion Perception

Completed NA Results posted Last updated 24 February 2021

What this trial tests

NA trial testing Mindful Breathing in Emotions in 91 participants. Completed in 2 December 2019.

Timeline

4 February 2019

Primary endpoint
2 December 2019

2 December 2019

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	91
Start date	4 February 2019
Primary completion	2 December 2019
Estimated completion	2 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Mindful Breathing
• Habituation
• Control

Conditions studied

• Emotions — all drugs for Emotions →

Sponsor

Duke University

Who can join

Adults 18 to 55, any sex, with Emotions. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment Primary · During the laboratory experiment (week 1)

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.

Group	Value	95% CI
Mindful Breathing	77.31	± 14.36
Habituation	81.93	± 17.94
Control	84.85	± 16

Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment Primary · After the one week of phone-based intervention

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 ratings of emotional valence range from 0-9, with higher scores as more positive emotional valence and lower scores as more negative emotional valence.

Group	Value	95% CI
Mindful Breathing	5.19	± 2.57
Habituation	5.3	± 2.54
Control	5.23	± 2.59

Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS) Secondary · Beginning of Week one laboratory experiment, End of Week one laboratory experiment

SUDS 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.

Group	Value	95% CI
Mindful Breathing	1.14	± 1.21
Habituation	0.61	± 0.9
Control	0.56	± 0.95

Sponsor's own description

The purpose of this study is to assess the impact of a brief, emotion regulation intervention on the ability to perceive other people's emotions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.