Understanding how to regulate emotions in depression

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

This study is testing a new way to help young adults with depression and healthy volunteers learn to manage their emotions better by using biofeedback and comparing their experiences in daily life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 18 Years to 27 Years
• Sex: All
• Sponsor: University of Southern California (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06345859 on ClinicalTrials.gov

What this trial studies

This study investigates the different subtypes of major depressive disorder by examining how individuals perceive their ability to regulate emotions and the physiological responses associated with these efforts. Participants, including young adults with remitted depression and healthy volunteers, will undergo ambulatory assessments of their emotional regulation strategies and physiological activity in daily life. The study also includes lab-based evaluations to explore neural and behavioral differences among subtypes. Participants will be randomly assigned to receive a biofeedback intervention aimed at improving emotional regulation or a control intervention.

Who should consider this trial

Good fit: Ideal candidates are young adults aged 18-27 who have a history of major depressive disorder but are currently in remission.

Not a fit: Patients with active psychiatric disorders or significant medical contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatments for individuals with major depressive disorder.

How similar studies have performed: Other studies have shown promise in using biofeedback and emotional regulation strategies for treating depression, suggesting potential for success in this approach.

Eligibility criteria

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).

Where this trial is running

Los Angeles, California

• University of Southern California — Los Angeles, California, United States (Recruiting)

Study contacts

• Study coordinator: Umiemah Farrukh

Conditions Major Depressive Disorder