A Precision Medicine Approach to Target Engagement for Emotion Regulation

NCT ID: NCT05651295

Last Updated: 2023-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-29

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Checking the Facts

Intervention Type 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.

Opposite to Emotion Action

Intervention Type 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).

Mindfulness of Current Emotions

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Checking the Facts

Intervention Type 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.

Opposite to Emotion Action

Intervention Type 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).

Mindfulness of Current Emotions

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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cognitive restructuring Opposite Action mindfulness acceptance

Eligibility Criteria

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Inclusion Criteria

* Elevated emotion dysregulation

Exclusion Criteria

* Lack of proficiency in English
* No access to smartphone
* Conditions requiring greater than outpatient care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Matthew Southward

OTHER

Sponsor Role lead

Responsible Party

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Matthew Southward

Research Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Matthew W Southward, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew W Southward, Ph.D.

Role: CONTACT

859-562-1569

Facility Contacts

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Matthew W Southward, Ph.D.

Role: primary

Other Identifiers

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K23MH126211

Identifier Type: NIH

Identifier Source: secondary_id

View Link

64865

Identifier Type: -

Identifier Source: org_study_id

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