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Stress Trajectories and Anhedonia in Adolescence Research Study

Stress Trajectories and Anhedonia in Adolescence Research Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07040449
Acronym
STAARS
Enrollment
192
Registered
2025-06-27
Start date
2025-03-12
Completion date
2030-02-28
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anhedonia, Stress Response, Adolescent Development

Brief summary

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.

Detailed description

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): Self-Report, Remote Questionnaires: demographic survey, address history survey, Protocol for Responding to & Assessing Patients' Assets, Risks & Experiences (PRAPARE), Pediatric Adverse Childhood Experiences and Related Life-events Screener (PEARLS) Cognitive (researcher administered, conducted in-person: Wechsler Abbreviated Scale of Intelligence Second Version (WASI-II) Psychological interview: Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) Time 2 (10-Months) Juvenile Victimization Questionnaire (JVQ) (self-report, completed remotely) Time 3 (20-Months) Psychological interview: Abbreviated Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)

Interventions

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.

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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

1. The Trier Social Stress Test for Children (TSST-C)-- 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. 2. The Montreal Imaging Stress Task (MIST) -- 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.

Eligibility

Sex/Gender
ALL
Age
13 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percent signal change during the MISTBaseline, 10-Months, 20-MonthsDuring 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 MISTBaseline, 10-Months, 20-MonthsDuring 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)Baseline, 10-Months, 20-MonthsThe 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.
Anhedonia as assessed by the SHAPSBaseline, 10-months, 20-monthsThe 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.
Endocrine (cortisol) response during the TSSTBaseline, 10-Months, 20-MonthsThe 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.

Secondary

MeasureTime frameDescription
Anhedonia as assessed by the TEPSBaseline, 10-months, 20-monthsThe Temporal Experience of Pleasure Scale (TEPS) is an 18-item measure used to assess anhedonia. It is scored on a 6-point Likert scale ranging from very false for me (1) to very true for me (6). The sum of these responses is taken to find the total score, which ranges from 18-108 with higher scores indicating more overall anhedonia.
Anhedonia as assessed by the ACIPSBaseline, 10-months, 20-monthsThe Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) assesses the ability to experience social pleasure. It contains 17-items scored on a 6-point Likert scale ranging from very false for me (1) to very true for me (6). The sum of these responses is taken to find the total score, which ranges from 17-102 with higher scores indicating lower capacity to experience or anticipate social pleasure.

Countries

United States

Contacts

Primary ContactClinical Research Coordinator
staars@unc.edu(919) 351-5201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026