A Precision Medicine Approach to Target Engagement for Emotion Regulation

Matthew Southward

Status: Enrolling

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

Treatments: Behavioral: Opposite to Emotion Action; Behavioral: Checking the Facts; Behavioral: Mindfulness of Current Emotions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05651295

K23MH126211 (U.S. NIH Grant/Contract)

64865

Details and patient eligibility

About

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.

Enrollment: 390 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elevated emotion dysregulation

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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390 participants in 2 patient groups

Personalized Condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mindfulness of Current Emotions

Behavioral: Checking the Facts

Behavioral: Opposite to Emotion Action

Standardized Condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mindfulness of Current Emotions

Behavioral: Checking the Facts

Behavioral: Opposite to Emotion Action