A Precision Medicine Approach to Target Engagement for Emotion Regulation

NCT05651295 | Unknown

• 2 other identifiers: 64865K23MH126211
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cognitive-behavior therapy; mechanism; ecological momentary assessment; personalization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Changes in Hamilton Depression Rating Scale

  Once every 2 weeks for 6 weeks (4 times total)

• 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)

Study Arms (2)

Personalized Condition

ACTIVE COMPARATOR

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; Behavioral: Opposite to Emotion Action; Behavioral: Mindfulness of Current Emotions

Standardized Condition

ACTIVE COMPARATOR

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; Behavioral: Opposite to Emotion Action; Behavioral: Mindfulness of Current Emotions

Interventions

Checking the Facts BEHAVIORAL

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.

Also known as: cognitive restructuring

Personalized Condition; Standardized Condition

Opposite to Emotion Action BEHAVIORAL

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).

Also known as: Opposite Action

Personalized Condition; Standardized Condition

Mindfulness of Current Emotions BEHAVIORAL

Mindfulness of Current Emotions teaches participants to nonjudgmentally observe the experience of their emotions, including physiological and cognitive responses to those emotions.

Also known as: mindfulness, acceptance

Personalized Condition; Standardized Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elevated emotion dysregulation

You may not qualify if:

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

Sponsors & Collaborators

• Matthew Southward: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

RECRUITING

MeSH Terms

Conditions

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

Interventions

Cognitive Restructuring; Mindfulness

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Behavioral Symptoms; Mental Disorders; Personality Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Matthew W Southward, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew W Southward, Ph.D.

CONTACT

859-562-1569; copingskillsstudy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 15, 2022
• Study Start: September 29, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)