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NCT Number: NCT05651295

A Precision Medicine Approach to Target Engagement for Emotion Regulation

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.

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Key information

Conditions

Emotional Regulation Anxiety Anxiety Disorders Behavior Behavioral Symptoms Borderline Personality Disorder Depression Eating Disorders Feeding and Eating Disorders Mental Disorders Obsessive-Compulsive Disorder Pathological Conditions, Signs and Symptoms Personality Disorders Posttraumatic Stress Disorder Self-Control Signs and Symptoms Signs and Symptoms, Digestive Social Behavior Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Matthew W Southward, Ph.D.

CONTACT

[email protected]

614-247-0331

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elevated emotion dysregulation

Exclusion criteria

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

Treatment and study plan

Checking the Facts

Behavioral

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

Opposite to emotion action

Behavioral

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

Mindfulness of Current Emotions

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew W Southward, Ph.D.

CONTACT

[email protected]

614-247-0331

Sponsors and collaborators

Lead sponsor

Matthew Southward, PhD

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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