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Clinical Trials/NCT05651295
NCT05651295
Recruiting
N/A

A Precision Medicine Approach to Target Engagement for Emotion Regulation

Matthew Southward1 site in 1 country390 target enrollmentSeptember 29, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Emotional Regulation
Sponsor
Matthew Southward
Enrollment
390
Locations
1
Primary Endpoint
Changes in Positive and Negative Affect Schedule-Short Form
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 29, 2023
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Matthew Southward
Responsible Party
Sponsor Investigator
Principal Investigator

Matthew Southward

Research Assistant Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • Elevated emotion dysregulation

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Changes in Hamilton Depression Rating Scale(Once every 2 weeks for 6 weeks (4 times total))
  • Changes in emotion regulation effectiveness(7 times per day for 48 days)
  • Changes in Hamilton Anxiety Rating Scale(Once every 2 weeks for 6 weeks (4 times total))
  • Changes in Five-Factor Model Score Sheet(Once every 2 weeks for 6 weeks (4 times total))
  • Changes in Ways of Responding Scale(Once every 2 weeks for 6 weeks (4 times total))
  • Changes in Opposite to Emotion Action Task(Once every 2 weeks for 6 weeks (4 times total))
  • Changes in Breath-Counting Task(Once every 2 weeks for 6 weeks (4 times total))

Study Sites (1)

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