EmotionsEREPNCT03790878

Emotion Regulation and Emotion Perception

A study testing Mindful Breathing and Habituation in people with Emotions, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Emotions
What is being tested?: Mindful Breathing and Habituation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2019to 2 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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

Conditions: Emotions
Being tested: Mindful Breathing, Habituation, Control
Keywords: Emotion Dysregulation, Empathy, Emotion Perception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindful BreathingBehavioural
Training in a mindful breathing skill that reduces emotional distress
HabituationBehavioural
An exposure procedure that reduces emotional distress through habituation
ControlBehavioural
No emotion regulation intervention, placebo

Study groups in NCT03790878
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: After the one week of phone-based intervention

Secondary outcomes (1)

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.
Measured: Beginning of Week one laboratory experiment, End of Week one laboratory experiment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 20192 Dec 2019

First posted2 Jan 2019
Study start4 Feb 2019
Primary completion2 Dec 2019
Study completion2 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EmotionsStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03790878
Sponsor's protocol ID: Pro00089935
Other IDs: 1F31MH117830-01A1
Acronym: EREP
Status last verified: Dec 2018
First submitted: 28 Dec 2018
Last updated: 24 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Will check with sponsors on Duke's policies for data sharing and may update the plan in the future.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Improving Emotional Wellbeing of University Students: Emotion Regulation
Emotion Regulation
Recruiting
Neural Mechanisms of Real-world Emotions and Internalizing
Major Depression, Generalized Anxiety
Active, not recruiting
Manage Emotions to Reduce Aggression (MERA)
Stress Disorders, Post-Traumatic, Aggression
Active, not recruiting
Investigating Baby Behavior and Family Technology Use Study
Mobile Phone Use, Mother-Infant Interaction
Not yet recruiting
Mandala-Based Intervention in Pregnancy
Perception of Traumatic Childbirth, Psychological Resilience

All Emotions trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Impact of an Emotion Regulation Intervention on Emotion Perception
ClinicalTrials.gov ID: NCT03790878
Acronym / sponsor ID: EREP / Pro00089935
Conditions: Emotions
Keywords: Emotion Dysregulation, Empathy, Emotion Perception
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), Mind and Life Institute, Hadley, Massachusetts
Study start: 4 Feb 2019 (actual)
Primary completion: 2 Dec 2019 (actual)
Study completion: 2 Dec 2019 (actual)
First posted: 2 Jan 2019 (actual)
Results: Posted 24 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Mindful Breathing	Experimental	Behavioral: Mindful BreathingParticipants 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.
Habituation	Active comparator	Behavioral: HabituationParticipants 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.
Control	Placebo comparator	Behavioral: ControlParticipants 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

Current mania;
Meets full criteria for any current psychotic disorder;
Currently/chronically homeless;
Current suicidal ideation;
Psychiatric hospitalization within past 6 months;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindful BreathingTraining in a mindful breathing skill that reduces emotional distress	Behavioural	Mindful Breathing
HabituationAn exposure procedure that reduces emotional distress through habituation	Behavioural	Habituation
ControlNo emotion regulation intervention, placebo	Behavioural	Control

Primary outcome

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.
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 24 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindful Breathing	26	26
Habituation	27	27
Control	27	27

Primary outcome: 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). Mean (Standard Deviation). Unit: Percent of correct responses

Measure	Mindful Breathing n = 25	Habituation n = 27	Control n = 27
Value	77.31 (14.36)	81.93 (17.94)	84.85 (16)

Mindful Breathing vs Habituation vs Control: p = 0.018, ANCOVA

Population analysed: Baseline data for one participant was not completed appropriately and was omitted from the analysis.

Primary outcome: Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment

Time frame: After the one week of phone-based intervention. Mean (Standard Deviation). Unit: units on a scale

Measure	Mindful Breathing n = 26	Habituation n = 27	Control n = 27
Value	5.19 (2.57)	5.3 (2.54)	5.23 (2.59)

Mindful Breathing vs Habituation vs Control: p = 0.396, Multilevel modeling

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 3 weeks. Adverse events were assessed at intake, training session, and exit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindful Breathing	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Habituation	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Control	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Will check with sponsors on Duke's policies for data sharing and may update the plan in the future.

Related trials for Emotions

Active, not recruiting
Improving Emotional Wellbeing of University Students: Emotion Regulation
Emotion Regulation
Recruiting
Neural Mechanisms of Real-world Emotions and Internalizing
Major Depression, Generalized Anxiety
Active, not recruiting
Manage Emotions to Reduce Aggression (MERA)
Stress Disorders, Post-Traumatic, Aggression
Active, not recruiting
Investigating Baby Behavior and Family Technology Use Study
Mobile Phone Use, Mother-Infant Interaction
Not yet recruiting
Mandala-Based Intervention in Pregnancy
Perception of Traumatic Childbirth, Psychological Resilience

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Z Rosenthal, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindful Breathing and Habituation in people with Emotions, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03790878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021; AzTrials last refreshed its copy on 29 Oct 2026.