Emotion Regulation and Emotion Perception

Emotions Clinical Trial

— EREP  

Official title:

Evaluating the Impact of an Emotion Regulation Intervention on Emotion Perception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790878
• Other study ID #: Pro00089935
• Secondary ID: 1F31MH117830-01A
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: December 2, 2019

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Decision to close enrollment was made on January 2, 2020.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. ages 18-55;

2. have a smartphone and agree to receive text-messages;

3. have difficulty with their relationships or social interactions;

4. high emotion dysregulation, assessed with the Difficulties with Emotion Regulation Scale (DERS)(Gratz & Roemer, 2004) with scores over 90.

Exclusion Criteria:

1. Current mania;

2. Meets full criteria for any current psychotic disorder;

3. Currently/chronically homeless;

4. Current suicidal ideation;

5. Psychiatric hospitalization within past 6 months;

6. Unable to read, blind or deaf. Our previous study recruited only participants who were currently in treatment, but this study will include both participants who are currently in treatment, as well as those who are not in treatment.

7. high self-reported autistic traits, as assessed by the Autism Spectrum Quotient (Auyeung & Baron-Cohen, 2012).

Related Conditions & MeSH terms

• Emotions

Intervention

Behavioral:
• Mindful Breathing
Training in a mindful breathing skill that reduces emotional distress
• Habituation
An exposure procedure that reduces emotional distress through habituation
• Control
No emotion regulation intervention, placebo

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Mind and Life Institute, Hadley, Massachusetts, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Emotional Arousal, as Measured by Skin Conductance Response (SCR)	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.	Laboratory assessment, up to one week
Primary	The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment	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.	During the laboratory experiment (week 1)
Primary	Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment	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.	After the one week of phone-based intervention
Secondary	Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS)	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.	Beginning of Week one laboratory experiment, End of Week one laboratory experiment