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Neural Predictors of Social Emotion Regulation Training

Primary Purpose

Emotions, Rumination

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social regulation
Self regulation
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Emotions

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Native English speaker
  • Right handed

Exclusion Criteria:

  • 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

Sites / Locations

  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social regulation

Self regulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in mood rating (Likert scale score)
Participants rate their response indicating their current emotions (e.g., angry, happy, sad) on a 9-point Likert scale ranging from 1 (completely disagree) to 9 (completely agree). The total score for positive mood is calculated from the sum of 4 positive emotion items. The total score for negative mood is calculated from the sum of 4 negative emotion items.
Change in Brief State Rumination Inventory (BSRI) (Likert scale score)
Participants rate their response indicating their ruminative thought (e.g., "Right now, I wonder why I react the way I do") on a 9-point Likert scale ranging from 1 (completely disagree) to 9 (completely agree). The total score is calculated from the sum of all 13 items.
State Trait Anxiety Inventory (STAI) - Trait Scale (Likert scale score)
The State Trait Anxiety Inventory - Trait scale (20 items) measures trait anxiety. 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 all items. Higher scores indicate higher anxiety.
Center for Epidemiologic Studies Depression Scale (CES-D) (Likert scale score)
The Center for Epidemiologic Studies Depression Scale (20 items) measures depression. Participants rate their response on a 4-point Likert scale ranging from 0 (Rarely or none of the time (less than 1 day)) to 3 (All of the time (5-7 days)). The total score is calculated from the sum of all items. Higher scores indicate higher depression level.

Full Information

First Posted
March 22, 2018
Last Updated
January 21, 2020
Sponsor
Columbia University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03487081
Brief Title
Neural Predictors of Social Emotion Regulation Training
Official Title
Neural Predictors of Social Emotion Regulation Training
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
February 11, 2019 (Actual)
Study Completion Date
February 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Prior research has demonstrated that helping others regulate their emotions has benefits for the support provider. But little is known about the basic brain mechanisms underlying this ability or how this ability can change with practice. To address these questions, this study has two parts. In the first, functional magnetic resonance imaging (fMRI) is used to gain insight into the brain systems involved in helping others regulate negative emotions by comparing them to the brain systems involved in regulating the participants' own negative emotions. In the second part, participants engage in three weeks of structured practice, or training, in either socially regulating others' emotions or in self-regulating their own emotions. The investigators predict that helping others regulate their emotions will involve many of the same brain regions implicated in regulating one's own emotions, in addition to regions involved in perspective taking and the reward of helping others. Further, when relating the brain data from part 1 to the regulation practice data from part 2, the investigators expect that individuals who in part 1 show greater activity in brain regions supporting either social or self-regulation may be more likely in part 2 to show corresponding improvements in regulation performance. The results of these studies are intended to lay the groundwork for future studies investigating the social regulation of emotion in older adults and clinical populations for whom social support can be beneficial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotions, Rumination

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social regulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Self regulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social regulation
Intervention Description
Participants will be instructed to help another person think about their negative events differently using an emotion regulation strategy called reappraisal.
Intervention Type
Behavioral
Intervention Name(s)
Self regulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emotion Regulation Questionnaire (ERQ) Score
Description
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.
Time Frame
Change from baseline at 3 weeks follow up
Title
Ruminative Response Scale (RRS) Score
Description
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.
Time Frame
Change from baseline at 3 weeks follow up
Secondary Outcome Measure Information:
Title
Change in mood rating (Likert scale score)
Description
Participants rate their response indicating their current emotions (e.g., angry, happy, sad) on a 9-point Likert scale ranging from 1 (completely disagree) to 9 (completely agree). The total score for positive mood is calculated from the sum of 4 positive emotion items. The total score for negative mood is calculated from the sum of 4 negative emotion items.
Time Frame
Baseline, up to 3 weeks
Title
Change in Brief State Rumination Inventory (BSRI) (Likert scale score)
Description
Participants rate their response indicating their ruminative thought (e.g., "Right now, I wonder why I react the way I do") on a 9-point Likert scale ranging from 1 (completely disagree) to 9 (completely agree). The total score is calculated from the sum of all 13 items.
Time Frame
Baseline, up to 3 weeks
Title
State Trait Anxiety Inventory (STAI) - Trait Scale (Likert scale score)
Description
The State Trait Anxiety Inventory - Trait scale (20 items) measures trait anxiety. 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 all items. Higher scores indicate higher anxiety.
Time Frame
Change from baseline at 3 weeks follow up
Title
Center for Epidemiologic Studies Depression Scale (CES-D) (Likert scale score)
Description
The Center for Epidemiologic Studies Depression Scale (20 items) measures depression. Participants rate their response on a 4-point Likert scale ranging from 0 (Rarely or none of the time (less than 1 day)) to 3 (All of the time (5-7 days)). The total score is calculated from the sum of all items. Higher scores indicate higher depression level.
Time Frame
Change from baseline at 3 weeks follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Native English speaker Right handed Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Ochsner, PhD
Organizational Affiliation
Department of Psychology, Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neural Predictors of Social Emotion Regulation Training

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