Regulation of Affect and Physiology in Depression

Major Depressive Disorder Clinical Trial

— RAPID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345859
• Other study ID #: UP-23-00467
• Secondary ID: R01MH133842
• Status: Recruiting
• Phase: Phase 2
• Start date: March 22, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: Umiemah Farrukh
• Phone: 2137404503
• Email: carlab[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: May 31, 2028
• Est. primary completion date: April 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 27 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Perceived regulation success	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.	The two 10-day ambulatory assessment periods.