NCT07040449 · University of North Carolina, Chapel Hill
Stress Trajectories and Anhedonia in Adolescence Research Study
(STAARS)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Montreal Imaging Stress Task
Psychosocial stress procedure consisting of completing sections of mental arithmetic that are 5.5 minutes in length, during which the individual receives neutral and negative evaluative feedback about their performance relative to their peers.
BEHAVIORAL
Trier Social Stress Test for Children
Psychosocial stress procedure in which the individual tells a story for 5 minutes in front of two neutral judges and performs mental arithmetic in front of the judges for 5 minutes.
Primary outcome measures
Anhedonia as assessed by the SHAPS
Time frame: Baseline, 10-months, 20-months
The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item measure used to assess anhedonia. Each item has four answer responses: "strongly agree" (1 point), "agree" (2 points), "disagree" (3 points), and "strongly disagree" (4 points). The sum of these responses is taken to find the total score, which ranges from 0-56 with higher scores indicating more overall anhedonia.
Percent signal change during the MIST
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 13-15 years old at study entry
- Ability to understand and sign an assent form
- Meets study hearing and vision requirements
Exclusion criteria
- Current use of antipsychotic medication
- Current use of medications that would interfere with cardiovascular or endocrine assessments
- Metal in the body or other MRI exclusion
- Central nervous system disorder or brain injury that could confound brain imaging evaluations
- Presence of a medical condition that would interfere with cardiovascular or endocrine assessments
- Impaired intellectual functioning
- Diagnosed with a neurodevelopmental disability
Where
- Chapel Hill, North Carolina
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
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Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 27, 2025 · Source of record for eligibility and locations