NCT06345859RecruitingPhase 2
Regulation of Affect and Physiology in Depression
Ambulatory Phenotyping With Real-Time Indices of Discordant Affect Regulation: Exploring Opportunities for Targeted Intervention in Depression
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- First submitted
- 28 Mar 2024
- Start date
- 22 Mar 2024
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- University of Southern California
- Diseases
- Depression
- NCT number
- NCT06345859
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 252
- From 22 Mar 2024 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in psychotropic medication use within the last 30 days
Other illness
- Autism spectrum disorder
- Current eating disorder
- 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).
Other
- Intellectual disability
Who the study is looking for
- 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.
Age in the registry: 18 years to 27 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.