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Completed

NCT Number: NCT03790878

Emotion Regulation and 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.

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Key information

Conditions

Emotions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ages 18-55;
  • have a smartphone and agree to receive text-messages;
  • have difficulty with their relationships or social interactions;
  • high emotion dysregulation, assessed with the Difficulties with Emotion Regulation Scale (DERS)(Gratz & Roemer, 2004) with scores over 90.

Exclusion criteria

  • Current mania;
  • Meets full criteria for any current psychotic disorder;
  • Currently/chronically homeless;
  • Current suicidal ideation;
  • Psychiatric hospitalization within past 6 months;
  • 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.
  • high self-reported autistic traits, as assessed by the Autism Spectrum Quotient (Auyeung & Baron-Cohen, 2012).

Treatment and study plan

Mindful Breathing

Behavioral

Training in a mindful breathing skill that reduces emotional distress

Habituation

Behavioral

An exposure procedure that reduces emotional distress through habituation

Control

Behavioral

No emotion regulation intervention, placebo

Primary outcomes

  1. The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment

    Time frame: 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.

  2. Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment

    Time frame: 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.

Secondary outcomes

  1. Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS)

    Time frame: 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Mind and Life Institute, Hadley, Massachusetts
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Evaluating the Impact of an Emotion Regulation Intervention on Emotion Perception

Acronym: EREP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2019
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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