A Precision Medicine Approach to Target Engagement for Emotion Regulation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMatthew Southward, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elevated emotion dysregulation

Disqualifiers

Lack of proficiency in English

No access to smartphone

Conditions requiring greater than outpatient care

Trial design

Design model

Parallel

Treatments tested in this trial

  • Checking the Facts

    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

    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

    Behavioral

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

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: Personalized ConditionActive comparator 3 interventions
Group B: Standardized ConditionActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
7 times per day for 42 days

Secondary outcomes

1

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.

Time frame
Once every 2 weeks for 6 weeks (4 times total)
2

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.

Time frame
Once every 2 weeks for 6 weeks (4 times total)
3

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.

Time frame
Once every 2 weeks for 6 weeks (4 times total)
4

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.

Time frame
Once every 2 weeks for 6 weeks (4 times total)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matthew Southward, PhD

Lead sponsor

Ohio State University

Sponsor institution

National Institute of Mental Health (NIMH)

Collaborator