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NCT Number: NCT06345859

Regulation of Affect and Physiology in Depression

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.

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Key information

Age range

18 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Southern California

Los Angeles, California, 90089, United States

Location status: Recruiting

Location contact

Umiemah Farrukh

CONTACT

[email protected]

2137404503

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Heart rate variability biofeedback

Behavioral

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

  1. Physiological regulation success

    Time frame: The two 10-day ambulatory assessment periods.

    A slope representing the strength of the relationship between how much each individual's heart rate variability increases after engaging in adaptive regulation strategies (reappraisal, distraction, and/or acceptance). Values of this variable during the 10-day biofeedback intervention period will be compared to values during the 10-day baseline ambulatory assessment periods.

  2. Average level of heart rate variability

    Time frame: The two 10-day ambulatory assessment periods.

    An intercept representing the average level of heart rate variability each person experienced. Values of this variable during the 10-day biofeedback intervention period will be compared to values during the 10-day baseline ambulatory assessment periods.

Secondary outcomes

  1. Perceived regulation success

    Time frame: The two 10-day ambulatory assessment periods.

    An intercept representing the average degree of success each person perceived in regulating their affect. Values of this variable during the 10-day biofeedback intervention period will be compared to values during the 10-day baseline ambulatory assessment periods.

Study contacts

Contact information is provided by the study sponsor or research team.

Umiemah Farrukh

CONTACT

[email protected]

2137404503

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: RAPID

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 3, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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