Neural Predictors of Social Emotion Regulation Training

Emotions Clinical Trial

Official title:

Neural Predictors of Social Emotion Regulation Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487081
• Other study ID #: AAAR8654
• Secondary ID: R01AG043463
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: February 11, 2019

Study information

• Verified date: January 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 11, 2019
• Est. primary completion date: February 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotions
• Rumination

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline, up to 3 weeks
Secondary	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.	Baseline, up to 3 weeks
Secondary	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.	Change from baseline at 3 weeks follow up
Secondary	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.	Change from baseline at 3 weeks follow up