RecruitingPhase 2NCT06345859

Regulation of Affect and Physiology in Depression

Ambulatory Phenotyping With Real-Time Indices of Discordant Affect Regulation: Exploring Opportunities for Targeted Intervention in Depression


Sponsor

University of Southern California

Enrollment

252 participants

Start Date

Mar 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes.


Eligibility

Min Age: 18 YearsMax Age: 27 Years

Plain Language Summary

Simplified for easier understanding

This study examines how the brain and body regulate emotions in young adults who have recovered from depression. Using brain scans and physiological measurements, it aims to understand what makes some people more vulnerable to depression returning. **You may be eligible if...** - You are between 18 and 27 years old - You have a history of major depression but are currently in full remission (no significant symptoms for at least 8 weeks) - OR you are a healthy volunteer with no history of any psychiatric disorder and no family history of mood disorders **You may NOT be eligible if...** - You have changed psychiatric medications in the last 30 days - You have autism spectrum disorder, an eating disorder, intellectual disability, or a current substance use disorder - You have any reason you cannot safely undergo an MRI scan (such as metal implants) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHeart rate variability biofeedback

This is a Phase 2 parallel intervention design with random assignment. We will randomly assign participants to one of two biofeedback conditions. Both conditions involve completing breathing exercises at home, 30 minutes per day for 10 days, while receiving continuous feedback about parasympathetic activity from the computer.


Locations(1)

University of Southern California

Los Angeles, California, United States

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NCT06345859


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