Stress Trajectories and Anhedonia in Adolescence Research Study

NCT07040449 | Recruiting DMC

• 2 other identifiers: 24-1236R01MH136102
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Anhedonia; Stress Response; Adolescent Development

Outcome Measures

Primary Outcomes (5)

• Anhedonia as assessed by the SHAPS

  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.

  Baseline, 10-months, 20-months

• Percent signal change during the MIST

  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%.

  Baseline, 10-Months, 20-Months

• Endocrine (cortisol) response during the TSST

  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.

  Baseline, 10-Months, 20-Months

• Endocrine (cortisol) response during the MIST

  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.

  Baseline, 10-Months, 20-Months

• Sympathetic and Parasympathetic nervous system ECG activation or heart rate variability (HRV) during a psychosocial stressful task (Trier Social Stress Test - TSST)

  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.

  Baseline, 10-Months, 20-Months

Secondary Outcomes (2)

• Anhedonia as assessed by the ACIPS

  Baseline, 10-months, 20-months

• Anhedonia as assessed by the TEPS

  Baseline, 10-months, 20-months

Study Arms (1)

Adolescent Teenagers

EXPERIMENTAL

Participants aged 13-15 (approximately Tanner pubertal stage 2-4) at study entry.

Behavioral: Montreal Imaging Stress Task; Behavioral: Trier Social Stress Test for Children

Interventions

Montreal Imaging Stress Task BEHAVIORAL

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.

Adolescent Teenagers

Trier Social Stress Test for Children BEHAVIORAL

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.

Adolescent Teenagers

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 13-15 years old at study entry
• Ability to understand and sign an assent form
• Meets study hearing and vision requirements

You may not qualify if:

• Current use of antipsychotic medication
• Current use of medications that would interfere with cardiovascular or endocrine assessments
• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Anhedonia; Fractures, Stress

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Aysenil Belger, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Danielle Roubinov, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

(919) 351-5201; staars@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available to the public after the conclusion of the study and the publication of the manuscripts.
• Access Criteria: Access to the data is limited to individuals who meet the following data access eligibility criteria as described on the NIMH NDA website: 1. Research Need 2. Electronic Research Administration (eRA) Commons Account 3. Institutional Association 4. Active Federal-Wide Assurance (FWA) 5. NDA Account

Locations

US (1)