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A Precision Medicine Approach to Target Engagement for Emotion Regulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05651295
Recruitment Status : Not yet recruiting
First Posted : December 15, 2022
Last Update Posted : May 31, 2023
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Matthew Southward, University of Kentucky

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Emotional Regulation Depression Anxiety Borderline Personality Disorder Obsessive-Compulsive Disorder Posttraumatic Stress Disorder Eating Disorders Behavioral: Checking the Facts Behavioral: Opposite to Emotion Action Behavioral: Mindfulness of Current Emotions Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Precision Medicine Approach to Target Engagement for Emotion Regulation
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elevated emotion dysregulation

Exclusion Criteria:

  • Lack of proficiency in English
  • No access to smartphone
  • Conditions requiring greater than outpatient care
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05651295


Contacts
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Contact: Matthew W Southward, Ph.D. 859-562-1569 copingskillsstudy@gmail.com

Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40508
Contact: Matthew W Southward, Ph.D.         
Sponsors and Collaborators
Matthew Southward
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Matthew W Southward, Ph.D. University of Kentucky
More Information
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Responsible Party: Matthew Southward, Research Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT05651295    
Other Study ID Numbers: 64865
K23MH126211 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2022    Key Record Dates
Last Update Posted: May 31, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Southward, University of Kentucky:
cognitive-behavior therapy
mechanism
ecological momentary assessment
personalization
Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Obsessive-Compulsive Disorder
Stress Disorders, Post-Traumatic
Personality Disorders
Borderline Personality Disorder
 Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Anxiety Disorders