Recruiting

Regulation of Affect and Physiology in Depression

ClinicalTrials.gov IDNCT06345859

PhasePHASE2

Enrollment252

SponsorUniversity of Southern California

Age18 Years

SexALL

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Conditions studied

Major Depressive Disorder

About this study

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.

Interventions

Behavioral: Heart 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.

Primary outcomes

Physiological regulation success (The two 10-day ambulatory assessment periods.)
Average level of heart rate variability (The two 10-day ambulatory assessment periods.)

Eligibility information

Inclusion Criteria for Participants with Remitted Depression: 1. Age 18-27. 2. Meeting criteria for lifetime major depressive disorder. 3. Currently meeting criteria for full remission (absence of clinically significant symptoms) for at least eight weeks, and having a Hamilton Depression Rating Scale score of less than or equal to 7. Inclusion Criteria for Healthy Volunteer Participants: 1. Age 18-27. 2. No lifetime history of any psychiatric disorder. 3. No first-degree relatives with a mood disorder. Exclusion Criteria (same for all participants): 1. Change in psychotropic medication use within the last 30 days 2. Autism spectrum disorder 3. Current eating disorder 4. Intellectual disability 5. Substance use disorder within the past 6 months 6. Contraindications for magnetic resonance imaging or electrocardiogram assessment (e.g., presence of metal in body, claustrophobia, cardiac device, pregnancy).

Study locations

University of Southern California, Los Angeles, California 90089 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.