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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Obsessive-Compulsive Disorder; Anxiety; Borderline Personality Disorder; Posttraumatic Stress Disorder; Eating Disorders; Emotional Regulation
• Intervention / Treatment: Behavioral: Checking the Facts; Behavioral: Opposite to Emotion Action; Behavioral: Mindfulness of Current Emotions

• Study Type: Interventional
• Enrollment (Anticipated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew W Southward, Ph.D.; Phone Number: 859-562-1569; Email: [email protected]

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • University of Kentucky
      • Contact: Matthew W Southward, Ph.D.

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 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

Outcome Measure	Measure Description	Time Frame
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.	7 times per day for 42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	7 times per day for 48 days

Collaborators and Investigators

• Sponsor: Matthew Southward
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Matthew W Southward, Ph.D., University of Kentucky

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: ecological momentary assessment; mechanism; cognitive-behavior therapy; personalization
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Anxiety Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Personality Disorders; Disease; Obsessive-Compulsive Disorder; Stress Disorders, Post-Traumatic; Feeding and Eating Disorders; Borderline Personality Disorder
• Other Study ID Numbers: 64865; 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