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A Precision Medicine Approach to Target Engagement for Emotion Regulation

A Precision Medicine Approach to Target Engagement for Emotion Regulation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05651295
Enrollment
390
Registered
2022-12-15
Start date
2023-09-29
Completion date
2026-12-31
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALChecking 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.

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).

BEHAVIORALMindfulness 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.

Sponsors

Matthew Southward, PhD
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elevated emotion dysregulation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Positive and Negative Affect Schedule-Short Form7 times per day for 42 daysA 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.

Secondary

MeasureTime frameDescription
Changes in Hamilton Depression Rating ScaleOnce every 2 weeks for 6 weeks (4 times total)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.
Changes in Hamilton Anxiety Rating ScaleOnce every 2 weeks for 6 weeks (4 times total)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.
Changes in Five-Factor Model Score SheetOnce every 2 weeks for 6 weeks (4 times total)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.
Changes in Ways of Responding ScaleOnce every 2 weeks for 6 weeks (4 times total)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.
Changes in Opposite to Emotion Action TaskOnce every 2 weeks for 6 weeks (4 times total)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.
Changes in Breath-Counting TaskOnce every 2 weeks for 6 weeks (4 times total)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.
Changes in emotion regulation effectiveness7 times per day for 48 daysA 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.

Countries

United States

Contacts

CONTACTMatthew W Southward, Ph.D.
copingskillsstudy@gmail.com614-247-0331
PRINCIPAL_INVESTIGATORMatthew W Southward, Ph.D.

Ohio State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026