Emotion Regulation and Emotion Perception

NCT ID: NCT03790878

Last Updated: 2021-02-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2019-12-02

Brief Summary

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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

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

Conditions

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Emotions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mindful Breathing

Intervention Type BEHAVIORAL

Training in a mindful breathing skill that reduces emotional distress

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.

Group Type ACTIVE_COMPARATOR

Habituation

Intervention Type BEHAVIORAL

An exposure procedure that reduces emotional distress through habituation

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.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

No emotion regulation intervention, placebo

Interventions

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Mindful Breathing

Training in a mindful breathing skill that reduces emotional distress

Intervention Type BEHAVIORAL

Habituation

An exposure procedure that reduces emotional distress through habituation

Intervention Type BEHAVIORAL

Control

No emotion regulation intervention, placebo

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Mind and Life Institute, Hadley, Massachusetts

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Z Rosenthal, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1F31MH117830-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00089935

Identifier Type: -

Identifier Source: org_study_id

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