Regulation of Affect and Physiology in Depression

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06345859
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 27 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 22, 2024
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
May 31, 2028

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Osc+
    Osc+ condition. In the Osc+ condition, participants will see an on-going record of their heart rate over time. They will be instructed to engage in paced breathing and to try to maximize their oscillation score. The paced breathing will be adapted to a rate that allows them to maximize their high amplitude heart rate oscillations.
  • Active Comparator: Osc-
    Osc- condition. In the Osc- condition, participants will also see an on-going record of their heart rate over time, and will be instructed to engage in paced breathing. However, they will be asked to try to keep their heart rate steady and avoid oscillations and will get points on an 'alertness' score that inverts the Osc+ 'oscillation' score.

Primary Outcome Measure

Physiological regulation success [ Time Frame: The two 10-day ambulatory assessment periods. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90089
Umiemah Farrukh
[email protected]
2137404503

Find similar trials in Los Angeles, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Southern California· Los Angeles, CA

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