Depression Clinical Trial
Official title:
A Precision Medicine Approach to Target Engagement for Emotion Regulation
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.
Status | Recruiting |
Enrollment | 390 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Elevated emotion dysregulation Exclusion Criteria: - Lack of proficiency in English - No access to smartphone - Conditions requiring greater than outpatient care |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Matthew Southward | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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 |
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