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Regulation of Affect and Physiology in Depression - Trial NCT06345859

Access comprehensive clinical trial information for NCT06345859 through Pure Global AI's free database. This Phase 2 trial is sponsored by University of Southern California and is currently Recruiting. The study focuses on Major Depressive Disorder. Target enrollment is 252 participants.

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NCT06345859
Phase 2
Recruiting
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06345859
View on ClinicalTrials.gov
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Regulation of Affect and Physiology in Depression
Ambulatory Phenotyping With Real-Time Indices of Discordant Affect Regulation: Exploring Opportunities for Targeted Intervention in Depression

Study Focus

Major Depressive Disorder

Heart rate variability biofeedback

Interventional

behavioral

Sponsor & Location

University of Southern California

Los Angeles, United States of America

Timeline & Enrollment

Phase 2

Mar 22, 2024

May 31, 2028

252 participants

Primary Outcome

Physiological regulation success,Average level of heart rate variability

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.

ICD-10 Classifications

Recurrent depressive disorder
Recurrent depressive disorder, unspecified
Depressive conduct disorder
Other recurrent depressive disorders
Recurrent depressive disorder, current episode moderate

Data Source

ClinicalTrials.gov

NCT06345859

Non-Device Trial