A Precision Medicine Approach to Target Engagement for Emotion Regulation

• ClinicalTrials.gov Identifier: NCT05651295
• Recruitment Status: Not yet recruiting
• First Posted: December 15, 2022
• Last Update Posted: May 31, 2023
• Sponsor: Matthew Southward
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Matthew Southward, University of Kentucky

Tracking Information

• First Submitted Date: December 1, 2022
• First Posted Date: December 15, 2022
• Last Update Posted Date: May 31, 2023
• Estimated Study Start Date: June 2023
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 12, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 12, 2022)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Precision Medicine Approach to Target Engagement for Emotion Regulation
• Official Title: A Precision Medicine Approach to Target Engagement for Emotion Regulation
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Emotional Regulation
• Depression
• Anxiety
• Borderline Personality Disorder
• Obsessive-Compulsive Disorder
• Posttraumatic Stress Disorder
• Eating Disorders

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Behavioral: Checking the Facts
  • Behavioral: Opposite to Emotion Action
  • Behavioral: Mindfulness of Current Emotions
• 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.
  Interventions:

  • Behavioral: Checking the Facts
  • Behavioral: Opposite to Emotion Action
  • Behavioral: Mindfulness of Current Emotions

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: December 12, 2022): 390
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Elevated emotion dysregulation

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05651295
• Other Study ID Numbers: 64865; K23MH126211 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Matthew Southward, University of Kentucky
• Original Responsible Party: Same as current
• Current Study Sponsor: Matthew Southward
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Matthew W Southward, Ph.D.; University of Kentucky

• PRS Account: University of Kentucky
• Verification Date: May 2023