Emotional RegulationNCT05651295
A Precision Medicine Approach to Target Engagement for Emotion Regulation
A study testing Checking the Facts, Opposite to Emotion Action and Mindfulness of Current Emotions in people with Emotional Regulation and Depression, run by Matthew Southward, PhD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Regulation, Depression, Anxiety
- What is being tested?
- Checking the Facts, Opposite to Emotion Action and Mindfulness of Current Emotions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated emotion dysregulation
Who cannot join
- Lack of proficiency in English
- No access to smartphone
- Conditions requiring greater than outpatient care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Matthew W Southward, Ph.D., 614-247-0331, copingskillsstudy@gmail.com
About this study
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.
- Conditions
- Emotional Regulation, Depression, Anxiety, Borderline Personality Disorder, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder
- Being tested
- Checking the Facts, Opposite to Emotion Action, Mindfulness of Current Emotions
- Keywords
- cognitive-behavior therapy, mechanism, ecological momentary assessment, personalization
- Medical subject headings
- Emotional Regulation, Depression, Anxiety Disorders, Borderline Personality Disorder, Obsessive-Compulsive Disorder, Stress Disorders, Post-Traumatic, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checking the FactsBehavioural
Also called cognitive restructuring
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.
Opposite to Emotion ActionBehavioural
Also called Opposite 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).
Mindfulness of Current EmotionsBehavioural
Also called mindfulness, acceptance
Mindfulness of Current Emotions teaches participants to nonjudgmentally observe the experience of their emotions, including physiological and cognitive responses to those emotions.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Condition | Active comparator | 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. Receives: Behavioral: Checking the Facts; Behavioral: Opposite to Emotion Action; Behavioral: Mindfulness of Current Emotions |
| Standardized Condition | Active comparator | 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. Receives: Behavioral: Checking the Facts; Behavioral: Opposite to Emotion Action; Behavioral: Mindfulness of Current Emotions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Positive and Negative Affect Schedule-Short Form
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.
Measured: 7 times per day for 42 days
Secondary outcomes (7)
Changes in Hamilton Depression Rating Scale
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.
Measured: Once every 2 weeks for 6 weeks (4 times total)
Changes in Hamilton Anxiety Rating Scale
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.
Measured: Once every 2 weeks for 6 weeks (4 times total)
Changes in Five-Factor Model Score Sheet
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.
Measured: Once every 2 weeks for 6 weeks (4 times total)
Changes in Ways of Responding Scale
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.
Measured: Once every 2 weeks for 6 weeks (4 times total)
Changes in Opposite to Emotion Action Task
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.
Measured: Once every 2 weeks for 6 weeks (4 times total)
Changes in Breath-Counting Task
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.
Measured: Once every 2 weeks for 6 weeks (4 times total)
Changes in emotion regulation effectiveness
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.
Measured: 7 times per day for 48 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start29 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional RegulationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Southward, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Matthew Southward, PhD, Ohio State University
- Investigators
- Matthew W Southward, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651295
- Sponsor's protocol ID
- 2024B0416
- Other IDs
- K23MH126211
- Status last verified
- May 2026
- First submitted
- 1 Dec 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Precision Medicine Approach to Target Engagement for Emotion Regulation
- ClinicalTrials.gov ID
- NCT05651295
- Acronym / sponsor ID
- 2024B0416
- Conditions
- Emotional Regulation, Depression, Anxiety, Borderline Personality Disorder, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder
- Keywords
- cognitive-behavior therapy, mechanism, ecological momentary assessment, personalization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Matthew Southward, PhDUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Dec 2022 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Condition | Active comparator | Behavioral: Checking the Facts, Behavioral: Opposite to Emotion Action, Behavioral: Mindfulness of Current EmotionsParticipants 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. |
| Standardized Condition | Active comparator | Behavioral: Checking the Facts, Behavioral: Opposite to Emotion Action, Behavioral: Mindfulness of Current EmotionsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elevated emotion dysregulation
Key exclusion criteria (3 listed)
- Lack of proficiency in English
- No access to smartphone
- Conditions requiring greater than outpatient care
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 |
|---|---|---|
| Checking the FactsAlso: cognitive restructuringChecking 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. | Behavioural | Personalized Condition, Standardized Condition |
| Opposite to Emotion ActionAlso: Opposite ActionOpposite 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). | Behavioural | Personalized Condition, Standardized Condition |
| Mindfulness of Current EmotionsAlso: mindfulness, acceptanceMindfulness of Current Emotions teaches participants to nonjudgmentally observe the experience of their emotions, including physiological and cognitive responses to those emotions. | Behavioural | Personalized Condition, Standardized Condition |
Primary outcome
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 secondary outcomes
Changes in Hamilton Depression Rating Scale
Time frame: 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)
Changes in Five-Factor Model Score Sheet
Time frame: 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)
Changes in Opposite to Emotion Action Task
Time frame: 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)
Changes in emotion regulation effectiveness
Time frame: 7 times per day for 48 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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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.
Matthew W Southward, Ph.D. principal investigator
Ohio State 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 Checking the Facts, Opposite to Emotion Action and Mindfulness of Current Emotions in people with Emotional Regulation and Depression, run by Matthew Southward, PhD 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew W Southward, Ph.D. (614-247-0331, copingskillsstudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Positive and Negative Affect Schedule-Short Form (time frame: 7 times per day for 42 days). 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 11 May 2026.