NCT03487081

Brief Summary

The purpose of this study is to investigate the basic psychological and neural mechanisms underlying the social regulation of emotion - that is, how one person's actions can impact, or regulate - the emotions of another person - and how this ability changes with practice. As such, this study is not designed to directly address clinical health outcomes and provide no treatment or intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 2, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

March 22, 2018

Last Update Submit

January 21, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Emotion Regulation Questionnaire (ERQ) Score

    The Emotion Regulation Questionnaire (10 items) has 2 subscales - suppression and reappraisal. Participants rate their response on a 7-point Likert scale ranging from 1 (Strongly disagree) to 7 (Strongly agree). The total score is calculated from the sum of the items in each subscale. Higher scores indicate higher tendency to use the emotion regulation strategy.

    Change from baseline at 3 weeks follow up

  • Ruminative Response Scale (RRS) Score

    The Ruminative Response Scale (22 items) has 3 subscales - brooding, reflection and depression. Participants rate their response on a 4-point Likert scale ranging from 1 (Almost never) to 4 (Almost always). The total score is calculated from the sum of the items in each subscale. Higher scores indicate higher tendency to engage in ruminative thoughts.

    Change from baseline at 3 weeks follow up

Secondary Outcomes (4)

  • Change in mood rating (Likert scale score)

    Baseline, up to 3 weeks

  • Change in Brief State Rumination Inventory (BSRI) (Likert scale score)

    Baseline, up to 3 weeks

  • State Trait Anxiety Inventory (STAI) - Trait Scale (Likert scale score)

    Change from baseline at 3 weeks follow up

  • Center for Epidemiologic Studies Depression Scale (CES-D) (Likert scale score)

    Change from baseline at 3 weeks follow up

Study Arms (2)

Social regulation

EXPERIMENTAL

Following the fMRI session, participants in the social regulation group will be asked to rate their mood twice a day for 3 weeks. Furthermore, every other day, they will receive one event written by another participant. They will be asked to help the other person use emotion regulation strategies to feel less negative. The participant will answer brief questions related to his/her feelings after receiving the event and after providing social emotion regulation.

Behavioral: Social regulation

Self regulation

ACTIVE COMPARATOR

Following the fMRI session, participants in the self regulation group will be asked to rate their mood twice a day for 3 weeks. Furthermore, every other day, they will write an event that caused them negative emotions. They will be asked to use emotion regulation strategies to decrease their negative emotions. The participant will answer brief questions related to his/her feelings after writing the event and after implementing the emotion regulation strategy.

Behavioral: Self regulation

Interventions

Participants will be instructed to help another person think about their negative events differently using an emotion regulation strategy called reappraisal.

Social regulation
Self regulationBEHAVIORAL

Participants will be instructed to think about their negative events by reframing the meaning of the event. This is a typical strategy in emotion regulation research known as reappraisal.

Self regulation

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Native English speaker
  • Right handed

You may not qualify if:

  • Current or past history of neurological or psychiatric illness
  • Use of psychoactive drugs
  • Individuals who have metal devices or implants that cannot be removed from their body (e.g., piercings, pacemakers, copper intrauterine devices (IUDs))
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Rumination Syndrome

Interventions

Social Control, FormalProfessional Autonomy

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health Care Economics and OrganizationsProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Kevin Ochsner, PhD

    Department of Psychology, Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 3, 2018

Study Start

July 2, 2018

Primary Completion

February 11, 2019

Study Completion

February 11, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations