Emotion Regulation and Emotion Perception

NCT03790878 | Completed Results DMC

• 2 other identifiers: Pro000899351F31MH117830-01A1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emotions

Keywords

Emotion Dysregulation; Empathy; Emotion Perception

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  Beginning of Week one laboratory experiment, End of Week one laboratory experiment

Other Outcomes (1)

• Changes in Emotional Arousal, as Measured by Skin Conductance Response (SCR)

  Laboratory assessment, up to one week

Study Arms (3)

Mindful Breathing

EXPERIMENTAL

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

Habituation

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Interventions

Mindful Breathing BEHAVIORAL

Training in a mindful breathing skill that reduces emotional distress

Mindful Breathing

Habituation BEHAVIORAL

An exposure procedure that reduces emotional distress through habituation

Habituation

Control BEHAVIORAL

No emotion regulation intervention, placebo

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator
• Mind and Life Institute, Hadley, Massachusetts: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Habituation, Psychophysiologic

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Katherine (Kibby) McMahon
• Organization: Duke University

Kibby.McMahon@duke.edu

917-880-1551

Study Officials

• Mark Z Rosenthal, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 2, 2019
• Study Start: February 4, 2019
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: February 24, 2021
• Results First Posted: February 24, 2021

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)