A Precision Medicine Approach to Target Engagement for Emotion Regulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Checking the Facts, Opposite to Emotion Action, Mindfulness of Current Emotions.
- Who it may be relevant to
- Registry conditions: Emotional Regulation, Depression, Anxiety, Borderline Personality Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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. - 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). - 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.
Primary outcome measures
- Changes in Positive and Negative Affect Schedule-Short Form [Time frame: 7 times per day for 42 days]
Secondary outcome measures (7)
- Changes in Hamilton Depression Rating Scale [Time frame: Once every 2 weeks for 6 weeks (4 times total)]
- Changes in Hamilton Anxiety Rating Scale [Time frame: Once every 2 weeks for 6 weeks (4 times total)]
- Changes in Five-Factor Model Score Sheet [Time frame: Once every 2 weeks for 6 weeks (4 times total)]
- Changes in Ways of Responding Scale [Time frame: Once every 2 weeks for 6 weeks (4 times total)]
- Changes in Opposite to Emotion Action Task [Time frame: Once every 2 weeks for 6 weeks (4 times total)]
- Changes in Breath-Counting Task [Time frame: Once every 2 weeks for 6 weeks (4 times total)]
- Changes in emotion regulation effectiveness [Time frame: 7 times per day for 48 days]
Eligibility criteria
Inclusion criteria
- Elevated emotion dysregulation
Exclusion criteria
- Lack of proficiency in English
- No access to smartphone
- Conditions requiring greater than outpatient care
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Ohio State University — Columbus
Identifiers
NCT: NCT05651295 · 2024B0416 · K23MH126211