A Precision Medicine Approach to Target Engagement for Emotion Regulation

Depression Clinical Trial

Official title:

A Precision Medicine Approach to Target Engagement for Emotion Regulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651295
• Other study ID #: 64865
• Secondary ID: K23MH126211
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: University of Kentucky
• Contact: Matthew W Southward, Ph.D.
• Phone: 859-562-1569
• Email: copingskillsstudy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elevated emotion dysregulation

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anxiety
• Borderline Personality Disorder
• Depression
• Eating Disorders
• Emotional Regulation
• Feeding and Eating Disorders
• Obsessive-Compulsive Disorder
• Personality Disorders
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

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.
• 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).
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Matthew Southward	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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