Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
研究概览
简要总结
The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.
详细描述
Brain emotional processing was determined with the Emotional Faces Assessment Task (EFAT). In this task, participants view a trio of faces and match one of the two faces (bottom) that expresses the same emotion as the target face (top). The faces display one of five expressions (angry, happy, fearful, sad, neutral) and the other (incongruent) probe face always displays a neutral (or happy if the target is neutral) expression. The paradigm consists of 20 face trials per expression and 20 shape trials, presented in pseudorandomized order, separated by a 3-7 sec intertrial blank screen with fixation cross.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to study arm. The PI, study coordinator and research assistants will remain unblinded to perform safety assessments and provide feedback on intervention adherence. Blinded staff will wear buttons as an upfront visual cue to remind participants not to talk about their treatment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for traumatic stress
- •Normal or corrected to normal vision
- •Right-handed
- •Fluency in English
- •Physically able to travel for study visit attendance
排除标准
- •Significant chronic uncontrolled disease (e.g. uncontrolled diabetes, advanced liver disease, cancer, etc.)
- •Severe hearing problem
- •Intellectual disability or serious cognitive impairment
- •Inability to tolerate enclosed spaces (e.g. the MRI machine)
- •Ferrous-containing metals within the body
- •Pregnant, trying to get pregnant, or breastfeeding
- •Other research participation
- •Frequent number of special events during study period (weddings, concerts, exams, etc.)
研究组 & 干预措施
Light therapy A via the Re-Timer®
-15 minutes/day
干预措施: Light therapy A via the Re-Timer® (Device)
Light therapy B via the Re-Timer®
-30 minutes/day
干预措施: Light therapy B via the Re-Timer® (Device)
Light therapy C via the Re-Timer®
-60 minutes/day
干预措施: Light therapy C via the Re-Timer® (Device)
结局指标
主要结局
Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
时间窗: Baseline and treatment week 2 and treatment week 4
Participants completed the Emotional Faces Assessment Task (EFAT) during the fMRI scan. The average blood-oxygen-level-dependent (BOLD) signal change between the display of negative faces versus display of shapes was derived for the left and right amygdala separately. Higher levels indicate greater amygdala reactivity to negative faces versus display of shapes.
次要结局
未报告次要终点
研究者
Helen Burgess
Professor of Psychiatry
University of Michigan