Investigating the Effects of Social Stress on Brain Imaging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Differences in fMRI BOLD Response
研究概览
简要总结
The purpose of this study is to examine whether experiencing a social stressor prior to the collection of neuroimaging measures is associated with differences in brain activation in healthy participants.
详细描述
Using a randomized, parallel-group study design, this scientific investigation will examine the effect that experiencing the Trier Social Stress Test (TSST), the gold-standard for ethically inducing stress in a controlled laboratory setting, may have on neuroimaging measures of anxiety in healthy subjects. The study will enroll 50 healthy subjects who will be randomized to either experience the TSST or watch a nature film prior to undergoing task-based neuroimaging measures of emotional processing and self-referential processing using functional magnetic resonance imaging (fMRI).
This study will be conducted primarily at Massachusetts Institute of Technology with research and clinical support from Massachusetts General Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability and willingness to provide written informed consent.
- •Sufficiently fluent in English to participate in the trial.
- •Between 18-55 years of age (inclusive).
- •Right-hand dominant.
- •Current medications are stable for past 30 days (no changes to dose or frequency).
- •Negative result on pregnancy test (if female).
- •Negative result on urine drug screening.
- •Liebowitz Social Anxiety Scale (LSAS <30).
排除标准
- •History of bipolar disorder, schizophrenia, psychosis, delusional disorders.
- •History of eating disorder within past 6 months.
- •History of any traumatic brain injury.
- •Currently diagnosed with diabetes mellitus.
- •Presence of severe medical illness that would prevent completion of study procedures.
- •Presence of significant neurological illness or cognitive dysfunction (e.g.; seizures, dementia).
- •History of substance use disorder within past 6 months (other than nicotine and caffeine).
- •Use of any cannabis-containing products in past 30 days (CBD or THC).
- •Use of benzodiazepines in past 2 weeks.
- •Use of alpha- or beta-blockers in the past week.
- •History of claustrophobia.
- •Contraindications for MRI (e.g.; shrapnel).
- •Presence of any other medical condition that, in the investigator's opinion, may interfere with the study procedures.
研究组 & 干预措施
Film + TSST
Nature Film + Trier Social Stress Test (TSST)
干预措施: Trier Social Stress Test (TSST) (Behavioral)
Film Only (No-TSST)
Nature Film Only
结局指标
主要结局
Differences in fMRI BOLD Response
时间窗: 45 minutes after TSST
Patterns of brain activation measured as blood-oxygenation-level dependent (BOLD) signals will be assessed using 3.0 Tesla (3T) functional magnetic resonance imaging (fMRI). Several exploratory imaging paradigms, including the emotional face-matching task (EFMT) and the self-referential comment task (SRCT), will be used to examine differences between participants who experience the TSST and those who do not.
次要结局
- Change in Acute Subjective Anxiety(-180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes)
- Differences in Salivary Alpha Amylase(-180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes)