Ambulatory Phenotyping With Real-Time Indices of Discordant Affect Regulation: Exploring Opportunities for Targeted Intervention in Depression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Physiological regulation success
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 27 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Participants with Remitted Depression:
- •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
- •Inclusion Criteria for Healthy Volunteer Participants:
- •No lifetime history of any psychiatric disorder.
- •No first-degree relatives with a mood disorder.
排除标准
- •(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).
研究组 & 干预措施
Osc+
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.
干预措施: Heart rate variability biofeedback (Behavioral)
Osc-
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.
干预措施: Heart rate variability biofeedback (Behavioral)
结局指标
主要结局
Physiological regulation success
时间窗: The two 10-day ambulatory assessment periods.
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.
Average level of heart rate variability
时间窗: The two 10-day ambulatory assessment periods.
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.
次要结局
- Perceived regulation success(The two 10-day ambulatory assessment periods.)
研究者
Jonathan Stange
Assistant Professor of Psychology and Psychiatry & the Behavioral Sciences
University of Southern California