EmotionsNCT03487081
Neural Predictors of Social Emotion Regulation Training
A study testing Social regulation and Self regulation in people with Emotions and Rumination, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotions, Rumination
- What is being tested?
- Social regulation and Self regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 11 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Native English speaker
- Right handed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Emotions, Rumination
- Being tested
- Social regulation, Self regulation
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social regulationBehavioural
Participants will be instructed to help another person think about their negative events differently using an emotion regulation strategy called reappraisal.
Self regulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline at 3 weeks follow up
Secondary outcomes (4)
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.
Measured: Baseline, up to 3 weeks
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.
Measured: Baseline, up to 3 weeks
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.
Measured: Change from baseline at 3 weeks follow up
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.
Measured: Change from baseline at 3 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start2 Jul 2018
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kevin Ochsner, Columbia University
- Investigators
- Kevin Ochsner, PhD, Principal investigator, Department of Psychology, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487081
- Sponsor's protocol ID
- AAAR8654
- Other IDs
- R01AG043463
- Status last verified
- Jan 2020
- First submitted
- 22 Mar 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Predictors of Social Emotion Regulation Training
- ClinicalTrials.gov ID
- NCT03487081
- Acronym / sponsor ID
- AAAR8654
- Conditions
- Emotions, Rumination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social regulation | Experimental | Behavioral: Social regulationFollowing 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 comparator | Behavioral: Self regulationFollowing 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Native English speaker
- Right handed
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social regulationParticipants will be instructed to help another person think about their negative events differently using an emotion regulation strategy called reappraisal. | Behavioural | Social regulation |
| Self regulationParticipants 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. | Behavioural | Self regulation |
Primary outcome
Emotion Regulation Questionnaire (ERQ) Score
Time frame: Change from baseline at 3 weeks follow up
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
Time frame: Change from baseline at 3 weeks follow up
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.
4 secondary outcomes
Change in mood rating (Likert scale score)
Time frame: Baseline, up to 3 weeks
Change in Brief State Rumination Inventory (BSRI) (Likert scale score)
Time frame: Baseline, up to 3 weeks
State Trait Anxiety Inventory (STAI) - Trait Scale (Likert scale score)
Time frame: Change from baseline at 3 weeks follow up
Center for Epidemiologic Studies Depression Scale (CES-D) (Likert scale score)
Time frame: Change from baseline at 3 weeks follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Ochsner, PhD principal investigator
Department of Psychology, Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social regulation and Self regulation in people with Emotions and Rumination, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation Questionnaire (ERQ) Score (time frame: Change from baseline at 3 weeks follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.