A Precision Medicine Approach to Target Engagement for Emotion Regulation

Not Applicable

Recruiting

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

• Registration Number: NCT05651295
• Lead Sponsor: Matthew Southward

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 available

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-15
• Status Verified: 2023-09
• Study Start: 2023-09-29
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

• Elevated emotion dysregulation

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Positive and Negative Affect Schedule-Short Form	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

Name	Time	Method
Changes in Hamilton Anxiety Rating Scale	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	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 Hamilton Depression Rating Scale	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 emotion regulation effectiveness	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.
Changes in Ways of Responding Scale	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	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	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.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States