A Precision Medicine Approach to Target Engagement for Emotion Regulation

Study Overview
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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.

Official Title
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A Precision Medicine Approach to Target Engagement for Emotion Regulation

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

Intervention / Treatment
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* Behavioral: Checking the Facts
* Behavioral: Opposite to Emotion Action
* Behavioral: Mindfulness of Current Emotions


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Personalized Condition<br>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<br>* 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.<br>* Other names: cognitive restructuring;Behavioral: Opposite to Emotion Action<br>* 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).<br>* Other names: Opposite Action;Behavioral: Mindfulness of Current Emotions<br>* Mindfulness of Current Emotions teaches participants to nonjudgmentally observe the experience of their emotions, including physiological and cognitive responses to those emotions.<br>* Other names: acceptance;|
| Active Comparator: Standardized Condition<br>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<br>* 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.<br>* Other names: cognitive restructuring;Behavioral: Opposite to Emotion Action<br>* 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).<br>* Other names: Opposite Action;Behavioral: Mindfulness of Current Emotions<br>* Mindfulness of Current Emotions teaches participants to nonjudgmentally observe the experience of their emotions, including physiological and cognitive responses to those emotions.<br>* Other names: acceptance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive-behavior therapy, mechanism, ecological momentary assessment, personalization