Stress Trajectories and Anhedonia in Adolescence Research Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Anhedonia as assessed by the SHAPS
研究概览
简要总结
This project will examine how multiple biological measures from the brain and the body's stress response system contribute to anhedonia (the loss of pleasure) in adolescence. The goal of this project is to see if it is possible to combine these biological measures to describe different patterns of activity in the brain and body that adolescents may have in response to stress.
The main question this study aims to answer is whether different patterns of activity in the brain and body are related to whether adolescents develop anhedonia and how high or low levels of anhedonia are over time.
This study will enroll 192 adolescents who are between 13 and 15 years. Adolescents will complete tasks three times: at the beginning of the study, 10 months after that, and then 10 months after that. In total, they will be part of the study for 20 months. At each time, adolescents will complete surveys, provide samples of spit to measure hormones and provide pictures of their brain to measure brain activity, participate in mildly stressful tasks, and complete different activities that measure how they think. The investigators will also ask each adolescent's parent or legal guardian to answer some surveys about themselves and their child.
详细描述
Participants will complete tasks at 3 timepoints (Baseline, 10-Months, and 20-Months). Some tasks will be in-person, while others will be virtual.
The assessments being administered at all three timepoints are:
- Psychological measures (self-report, completed remotely): Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS), Mood and Feelings Questionnaire short version (MFQ), Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress and Anxiety, PROMIS Psychological Stress Experiences, Snaith-Hamilton Pleasure Scale (SHAPS), Temporal Experience of Pleasure Scale (TEPS)
- Cognitive (researcher administered, conducted in-person): NIH Cognitive Toolbox
- Brain Imaging via functional magnetic resonance imaging (fMRI)
- Physiological (researcher administered, conducted in-person): Heart Rate Variability (HRV), Photoplethysmography (PPG), Impedance Cardiography (ICG), Pre-Ejection Period (PEP), Salivary Cortisol
Additionally, the following will be administered at each respective timepoint:
Baseline Assessment (Month 0):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 13-15 years old at study entry
- •Ability to understand and sign an assent form
- •Meets study hearing and vision requirements
排除标准
- •Current use of medications that would interfere with cardiovascular or endocrine assessments
- •Metal in the body or other MRI exclusion
- •Medical condition or injury that could confound brain imaging evaluations or interfere with cardiovascular or endocrine assessments
- •Impaired intellectual functioning
- •Diagnosed with a neurodevelopmental disability
研究组 & 干预措施
Adolescent Teenagers
Participants aged 13-15 (approximately Tanner pubertal stage 2-4) at study entry.
干预措施: Montreal Imaging Stress Task (Behavioral)
Adolescent Teenagers
Participants aged 13-15 (approximately Tanner pubertal stage 2-4) at study entry.
干预措施: Trier Social Stress Test for Children (Behavioral)
结局指标
主要结局
Anhedonia as assessed by the SHAPS
时间窗: Baseline, 10-months, 20-months
The Snaith-Hamilton Pleasure Scale (SHAPS) is a measure used to assess anhedonia. It contains 14-items scored on a 4-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (4). The sum of these responses is taken to find the total score, which ranges from 0-56 with lower scores indicating higher overall anhedonia.
Endocrine (cortisol) response during the TSST
时间窗: Baseline
The Trier Social Stress Test for Children (TSST-C) -- a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic is used to elicit physiological stress responses. The combination of stressors offers high levels of social-evaluative threat. Cortisol is collected through a saliva sample of passive drool a total of 5 times throughout the visit at 15-minute intervals. The higher the cortisol is found to be, the higher the stress response to the task.
Sympathetic and Parasympathetic nervous system ECG activation or heart rate variability (HRV) during a psychosocial stressful task (Trier Social Stress Test - TSST)
时间窗: Baseline
The Trier Social Stress Test for Children (TSST-C) -- a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic is used to elicit physiological stress responses. The combination of stressors offers high levels of social-evaluative threat. Throughout the task, heart rate is measured to determine baseline resting state and HRV. HRV is the difference in the milliseconds between each heartbeat. The higher the HRV, the more the nervous system is activated during the task. The level of HRV indicates the participant's nervous system response to stress.
Percent signal change during the MIST
时间窗: Baseline, 10-Months, 20-Months
During the MIST, research participants complete mental arithmetic with the intermittent reception of neutral and negative evaluative feedback. The percent signal change of the fronto-limbic region of the brain will be analyzed during the MIST task. Higher percent signal change in these regions would indicate higher levels of activation when stressed. Percent signal change ranges between 1% to 5%.
Endocrine (cortisol) response during the TSST
时间窗: Baseline, 10-Months, 20-Months
The Trier Social Stress Test for Children (TSST-C) -- a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic is used to elicit physiological stress responses. The combination of stressors offers high levels of social-evaluative threat. Cortisol is collected through a saliva sample of passive drool a total of 5 times throughout the visit at 15-minute intervals. The higher the cortisol is found to be, the higher the stress response to the task.
Endocrine (cortisol) response during the MIST
时间窗: Baseline, 10-Months, 20-Months
During the MIST, research participants complete mental arithmetic with the intermittent reception of neutral and negative evaluative feedback. Cortisol is collected through a saliva sample collected via cotton swab a total of 6 times throughout the visit at 15-minute intervals. The higher the cortisol is found to be, the higher the stress response to the task.
Sympathetic and Parasympathetic nervous system ECG activation or heart rate variability (HRV) during a psychosocial stressful task (Trier Social Stress Test - TSST)
时间窗: Baseline, 10-Months, 20-Months
The Trier Social Stress Test for Children (TSST-C) -- a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic is used to elicit physiological stress responses. The combination of stressors offers high levels of social-evaluative threat. Throughout the task, heart rate is measured to determine baseline resting state and HRV. HRV is the difference in the milliseconds between each heartbeat. The higher the HRV, the more the nervous system is activated during the task. The level of HRV indicates the participant's nervous system response to stress.
次要结局
- Anhedonia as assessed by the ACIPS(Baseline, 10-months, 20-months)
- Anhedonia as assessed by the TEPS(Baseline, 10-months, 20-months)