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Emotion Regulation and Emotion Perception (EREP)

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ClinicalTrials.gov Identifier: NCT03790878
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Mind and Life Institute, Hadley, Massachusetts
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Emotions Behavioral: Mindful Breathing Behavioral: Habituation Behavioral: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Impact of an Emotion Regulation Intervention on Emotion Perception
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

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




Primary Outcome Measures :
  1. The ability to perceive negative and positive emotional expressions, as measured by a behavioral computer-based assessment [ Time Frame: Laboratory assessment, up to one week ]
    Emotion perception is measured by a computer-based behavioral assessment during the laboratory session. Scores for negative emotional expressions and positive emotional expressions range from 0-30, with higher scores indicating greater emotion perception accuracy.

  2. Changes in emotion perception, as measured by a phone-based behavioral assessment [ Time Frame: 7 days ]
    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 negative emotional expressions and positive emotional expressions range from 0-21, with higher scores indicating greater emotion perception accuracy.


Secondary Outcome Measures :
  1. Emotional distress, as measured by Subjective Units of Distress (SUDS) [ Time Frame: Laboratory assessment, up to one week ]
    Scores are measured on a 10-point Likert self-report scale of Subjective Units of Distress (SUDS), ranging from 0-9 with higher scores indicating higher emotional distress (worse outcome).


Other Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790878


Contacts
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Contact: Kibby McMahon, MA 919-684-9952 Kibby.McMahon@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Katherine L McMahon, MA    917-880-1551    Kibby.McMahon@duke.edu   
Contact: Mark Z Rosenthal, PhD       Mark.Rosenthal@duke.edu   
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Mind and Life Institute, Hadley, Massachusetts
Investigators
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Principal Investigator: Mark Z Rosenthal, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03790878     History of Changes
Other Study ID Numbers: Pro00089935
1F31MH117830-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will check with sponsors on Duke's policies for data sharing and may update the plan in the future.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Emotion Dysregulation
Empathy
Emotion Perception