A Precision Medicine Approach to Target Engagement for Emotion Regulation

May 7, 2026 updated by: Matthew Southward, PhD
The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
390

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elevated emotion dysregulation

Exclusion Criteria:

  • Lack of proficiency in English
  • No access to smartphone
  • Conditions requiring greater than outpatient care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Personalized Condition
Participants will learn one of three emotion regulation skills (i.e., cognitive restructuring, opposite to emotion action, mindfulness) that is their personal strength, based on pre-Baseline emotion regulation capacities. They will watch an interactive video, created for the current study, in which they are taught the skill that is their personal strength. They will also be asked to complete a survey during the video in which they will input their own examples to practice the skill and to ensure attention to and comprehension of the material.
Behavioral: Checking the Facts
Checking the Facts is a form of cognitive reappraisal in which participants identify negatively-valenced automatic thoughts and both generate and consider evidence that challenges the validity of those thoughts.
Other Names:
  • cognitive restructuring
Behavioral: Opposite to Emotion Action
Opposite to Emotion Action teaches participants to identify their momentary emotion(s), identify the associated behavioral urge(s), and implement a behavior inconsistent with that urge (e.g., approaching a feared stimulus instead of avoiding it).
Other Names:
  • Opposite Action
Behavioral: Mindfulness of Current Emotions
Mindfulness of Current Emotions teaches participants to nonjudgmentally observe the experience of their emotions, including physiological and cognitive responses to those emotions.
Other Names:
  • mindfulness
  • acceptance
Active Comparator: Standardized Condition
Participants will learn all three ER skills: cognitive restructuring, opposite to emotion action, and mindfulness. Participants will be asked to watch three interactive videos that cover each skill to provide an analogue to clinical practice in which clinicians must choose whether to provide greater breadth or depth of skill coverage. These videos will be presented in a randomized order and will include the same surveys for attention and comprehension used in the Personalized Condition.
Behavioral: Checking the Facts
Checking the Facts is a form of cognitive reappraisal in which participants identify negatively-valenced automatic thoughts and both generate and consider evidence that challenges the validity of those thoughts.
Other Names:
  • cognitive restructuring
Behavioral: Opposite to Emotion Action
Opposite to Emotion Action teaches participants to identify their momentary emotion(s), identify the associated behavioral urge(s), and implement a behavior inconsistent with that urge (e.g., approaching a feared stimulus instead of avoiding it).
Other Names:
  • Opposite Action
Behavioral: Mindfulness of Current Emotions
Mindfulness of Current Emotions teaches participants to nonjudgmentally observe the experience of their emotions, including physiological and cognitive responses to those emotions.
Other Names:
  • mindfulness
  • acceptance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Positive and Negative Affect Schedule-Short Form
Time Frame: 7 times per day for 42 days
A self-report measure designed to assess the intensity of momentary negative affect. Scores range from 1 to 5, with higher scores indicating greater negative affect and lower scores indicating less negative affect.
7 times per day for 42 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Hamilton Depression Rating Scale
Time Frame: Once every 2 weeks for 6 weeks (4 times total)
A 17-item clinician-rated measure of the severity and frequency of depressive symptoms over the prior week. Scores range from 0 to 51, with higher scores indicating greater severity and frequency of depressive symptoms and lower scores indicating less severe or frequent depressive symptoms.
Once every 2 weeks for 6 weeks (4 times total)
Changes in Hamilton Anxiety Rating Scale
Time Frame: Once every 2 weeks for 6 weeks (4 times total)
A 14-item clinician-rated measure of the severity and frequency of anxiety symptoms over the prior week. Scores range from 0 to 56, with higher scores indicating greater severity and frequency of anxiety symptoms and lower scores indicating less severe or frequent anxiety symptoms.
Once every 2 weeks for 6 weeks (4 times total)
Changes in Five-Factor Model Score Sheet
Time Frame: Once every 2 weeks for 6 weeks (4 times total)
A 30-item clinician-rated measure of adaptive and maladaptive variants of the Big Five personality dimensions. Each item is rated from 1-7, with higher scores indicating more maladaptive variants of each Big Five personality dimension and lower scores indicating more adaptive variants of each Big Five personality dimension.
Once every 2 weeks for 6 weeks (4 times total)
Changes in Ways of Responding Scale
Time Frame: Once every 2 weeks for 6 weeks (4 times total)
Ratings, made by independent coders masked to participant and condition information, of the quality of written responses to 6 hypothetical stressful scenarios. Scores range from 1-7, with higher scores indicating higher quality responses and lower scores indicating lower quality responses.
Once every 2 weeks for 6 weeks (4 times total)
Changes in Opposite to Emotion Action Task
Time Frame: Once every 2 weeks for 6 weeks (4 times total)
A behavioral task in which participants are asked to act in ways that are inconsistent with difficult emotions in response to emotion inductions. Before and after each trial, participants will rate the intensity of their negative emotions using the PANAS Basic Negative Emotion scale, which is a self-report measure designed to assess the intensity of momentary negative affect. Scores range from 1 to 5, with higher scores indicating greater negative affect and lower scores indicating less negative affect.
Once every 2 weeks for 6 weeks (4 times total)
Changes in Breath-Counting Task
Time Frame: Once every 2 weeks for 6 weeks (4 times total)
A behavioral and psychophysiological task in which participants will use a keyboard to record how frequently they breathe during a 15-minute period, which will be compared to physiological recordings of breathing rates for accuracy. Scores range from 0-100%, with higher scores indicate greater accuracy and lower scores indicating lower accuracy.
Once every 2 weeks for 6 weeks (4 times total)
Changes in emotion regulation effectiveness
Time Frame: 7 times per day for 48 days
A one-item rating of the perceived effectiveness of participants' emotion regulation skills since the previous notification. Scores range from 0 to 4, with higher scores indicating greater effectiveness of the regulation and lower scores indicating less effectiveness of the regulation.
7 times per day for 48 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Matthew Southward, PhD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew W Southward, Ph.D., Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024B0416
  • K23MH126211 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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