Neural Predictors of Social Emotion Regulation Training
2 other identifiers
interventional
62
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedStudy Start
First participant enrolled
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2019
CompletedJanuary 23, 2020
January 1, 2020
7 months
March 22, 2018
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
EXPERIMENTALFollowing 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.
Self regulation
ACTIVE COMPARATORFollowing 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.
Interventions
Participants will be instructed to help another person think about their negative events differently using an emotion regulation strategy called reappraisal.
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.
Eligibility Criteria
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
- Columbia Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Columbia University
New York, New York, 10027, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Ochsner, PhD
Department of Psychology, Columbia University
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