Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07040449

Conditions

Anhedonia

Stress Response

Adolescent Development

Eligibility Criteria

Sex: All

Age: 13 - 15

Healthy Volunteers: Accepted

Interventions

Montreal Imaging Stress Task

Trier Social Stress Test for Children

Study Details

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

Study ID

NCT07040449

Start date

Mar 12, 2025

Status verified date

Aug, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 15

Healthy Volunteers: Accepted

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 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

Study Design

Enrollment

192 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Adolescent Teenagers

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

Interventions

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.

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 measure

  • Anhedonia as assessed by the SHAPS [ Time Frame: Baseline, 10-months, 20-months ]
  • Percent signal change during the MIST [ Time Frame: Baseline, 10-Months, 20-Months ]
  • Endocrine (cortisol) response during the TSST [ Time Frame: Baseline ]
  • Endocrine (cortisol) response during the MIST [ Time Frame: 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) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

(919) 351-5201staars@unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Clinical Research Coordinator

919-966-2927staars@unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-08-17.