Emotion Regulation and Emotion Perception (EREP)

Evaluating the Impact of an Emotion Regulation Intervention on Emotion Perception

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.

Study Overview

• Status: Completed
• Conditions: Emotions
• Intervention / Treatment: Behavioral: Mindful Breathing; Behavioral: Habituation; Behavioral: Control

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Habituation; 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.	Behavioral: Control; No emotion regulation intervention, placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Mental Health (NIMH); Mind and Life Institute, Hadley, Massachusetts

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 4, 2019
• Primary Completion (ACTUAL): December 2, 2019
• Study Completion (ACTUAL): December 2, 2019

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (ACTUAL): January 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Empathy; Emotion Dysregulation; Emotion Perception
• Other Study ID Numbers: Pro00089935; 1F31MH117830-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will check with sponsors on Duke's policies for data sharing and may update the plan in the future.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No