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RecruitingAccepts healthy volunteersPhase 2

Regulation of Affect and Physiology in Depression

University of Southern California · with National Institute of Mental Health (NIMH) · NCT06345859

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–27 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
252
US sites recruiting
1
Study start
March 22, 2024
Record last updated
May 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Heart rate variability biofeedback

Conditions: Major Depressive Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria for Participants with Remitted Depression:

  • Age 18-27.
  • Meeting criteria for lifetime major depressive disorder.
  • 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:

  • Age 18-27.
  • No lifetime history of any psychiatric disorder.
  • No first-degree relatives with a mood disorder.

Exclusion Criteria (same for all participants):

  • Change in psychotropic medication use within the last 30 days
  • Autism spectrum disorder
  • Current eating disorder
  • Intellectual disability
  • Substance use disorder within the past 6 months
  • Contraindications for magnetic resonance imaging or electrocardiogram assessment (e.g., presence of metal in body, claustrophobia, cardiac device, pregnancy).

Recruiting US locations

  • University of Southern California

    Los Angeles, CA 90089

    Site contact: Umiemah Farrukh · 2137404503 · carlab@usc.edu

Study contacts (from the official record)

  • Umiemah Farrukh · 2137404503 · carlab@usc.edu
All mental health studies in California →
Regulation of Affect and Physiology in Depression (NCT06345859) | Bored Studies