Regulation of Affect and Physiology in Depression

NCT06345859 | Recruiting Phase 2

• 2 other identifiers: UP-23-00467R01MH133842
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Physiological regulation success

  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.

  The two 10-day ambulatory assessment periods.

• Average level of heart rate variability

  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.

  The two 10-day ambulatory assessment periods.

Secondary Outcomes (1)

• Perceived regulation success

  The two 10-day ambulatory assessment periods.

Study Arms (2)

Osc+

EXPERIMENTAL

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.

Behavioral: Heart rate variability biofeedback

Osc-

ACTIVE COMPARATOR

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.

Behavioral: Heart rate variability biofeedback

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.

Osc+; Osc-

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Southern California: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Umiemah Farrukh

CONTACT

2137404503; [email protected]

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology and Psychiatry & the Behavioral Sciences

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: March 22, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)