AnhedoniaSTAARSNCT07040449

Stress Trajectories and Anhedonia in Adolescence Research Study

A study testing Montreal Imaging Stress Task and Trier Social Stress Test for Children in people with Anhedonia and Stress Response, run by University of North Carolina, Chapel Hill at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 13 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Anhedonia, Stress Response, Adolescent Development
What is being tested?: Montreal Imaging Stress Task and Trier Social Stress Test for Children
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: 1 siteUnited States
Study dates: 12 Mar 2025to Feb 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 15 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Research Coordinator contact

(919) 351-5201

staars@unc.edu

United States1 site, 1 recruiting

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Clinical Research Coordinator, 919-966-2927, staars@unc.edu
Recruiting

Other trials in United States

About this study

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.

Read the 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)

Conditions: Anhedonia, Stress Response, Adolescent Development
Being tested: Montreal Imaging Stress Task, Trier Social Stress Test for Children
Medical subject headings: Anhedonia, Fractures, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Montreal Imaging Stress TaskBehavioural
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 ChildrenBehavioural
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.

Study groups in NCT07040449
Study group	Role	What they receive
Adolescent Teenagers	Experimental	Participants aged 13-15 (approximately Tanner pubertal stage 2-4) at study entry. Receives: Behavioral: Montreal Imaging Stress Task; Behavioral: Trier Social Stress Test for Children

What is being measured

The primary outcome is the main question the study is designed to answer.

Anhedonia as assessed by the SHAPS
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.
Measured: 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%.
Measured: 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.
Measured: Baseline
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.
Measured: 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.
Measured: Baseline

Secondary outcomes (2)

Anhedonia as assessed by the ACIPS
The Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) assesses the ability to experience social pleasure. It contains 17-items scored on a 4-point Likert scale ranging from "really false for me" (1) to "really true for me" (4). The sum of these responses is taken to find the total score, which ranges from 17-102, with lower scores indicating higher overall anhedonia.
Measured: Baseline, 10-months, 20-months
Anhedonia as assessed by the TEPS
The 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 lower scores indicating higher overall anhedonia.
Measured: Baseline, 10-months, 20-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 2025Feb 2030

First posted27 Jun 2025
Study start12 Mar 2025
Primary completionFeb 2030 (estimated)
Study completionFeb 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnhedoniaStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 192 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07040449
Sponsor's protocol ID: 24-1236
Other IDs: R01MH136102
Acronym: STAARS
Status last verified: Aug 2026
First submitted: 18 Jun 2025
Last updated: 17 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: In accordance with National Institute of Mental Health (NIMH) policy, all individual-level data will be shared through the NIMH National Data Archive (NDA).

Interested in taking part?

Clinical Research Coordinator

(919) 351-5201

staars@unc.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 4
Neural Circuit Effects of Ketamine in Depression
Major Depressive Disorder
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Promoting Positive Emotions in Adolescents Using Positive Events Training: An Indicated Approach
Emotional Distress, Anhedonia
RecruitingPhase 3
Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
Bipolar Disorder (BD)
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French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Recruiting
Geolocation Positional System (GPS) Experience
Emotions, Anhedonia

All Anhedonia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stress Trajectories and Anhedonia in Adolescence Research Study
ClinicalTrials.gov ID: NCT07040449
Acronym / sponsor ID: STAARS / 24-1236
Conditions: Anhedonia, Stress Response, Adolescent Development
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 192 participants (estimated)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 12 Mar 2025 (actual)
Primary completion: Feb 2030 (estimated)
Study completion: Feb 2030 (estimated)
First posted: 27 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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):

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)

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Adolescent Teenagers	Experimental	Behavioral: Montreal Imaging Stress Task, Behavioral: Trier Social Stress Test for ChildrenParticipants aged 13-15 (approximately Tanner pubertal stage 2-4) at study entry.

Who may qualify

Ages: 13 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Montreal Imaging Stress TaskPsychosocial 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.	Behavioural	Adolescent Teenagers
Trier Social Stress Test for ChildrenPsychosocial 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.	Behavioural	Adolescent Teenagers

Primary outcome

Anhedonia as assessed by the SHAPS
Time frame: 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.
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
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
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.

2 secondary outcomes

Anhedonia as assessed by the ACIPS
Time frame: Baseline, 10-months, 20-months
Anhedonia as assessed by the TEPS
Time frame: Baseline, 10-months, 20-months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Individual participant dataSharing planned: Yes. In accordance with National Institute of Mental Health (NIMH) policy, all individual-level data will be shared through the NIMH National Data Archive (NDA).

Related trials for Anhedonia

Active, not recruitingPhase 4
Neural Circuit Effects of Ketamine in Depression
Major Depressive Disorder
Recruiting
Promoting Positive Emotions in Adolescents Using Positive Events Training: An Indicated Approach
Emotional Distress, Anhedonia
RecruitingPhase 3
Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
Bipolar Disorder (BD)
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Recruiting
Geolocation Positional System (GPS) Experience
Emotions, Anhedonia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Clinical Research Coordinator contact

(919) 351-5201

staars@unc.edu

Aysenil Belger, PhD principal investigator

University of North Carolina, Chapel Hill

Danielle Roubinov, PhD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Research Coordinator ((919) 351-5201, staars@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anhedonia as assessed by the SHAPS (time frame: Baseline, 10-months, 20-months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07040449.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.