Regulation of Affect and Physiology in Depression

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Physiological regulation success [Срок оценки: The two 10-day ambulatory assessment periods.]
• Average level of heart rate variability [Срок оценки: The two 10-day ambulatory assessment periods.]

Вторичные конечные точки (1)

• Perceived regulation success [Срок оценки: The two 10-day ambulatory assessment periods.]

Критерии участия

Inclusion Criteria for Participants with Remitted Depression:

• 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.

Inclusion Criteria for Healthy Volunteer Participants:

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

Exclusion Criteria (same for all participants):

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Southern California — Los Angeles

Идентификаторы

NCT: NCT06345859 · UP-23-00467 · R01MH133842

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗