Stress Trajectories and Anhedonia in Adolescence Research Study

Overview

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

• 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]
• Percent signal change during the MIST [Time frame: Baseline, 10-Months, 20-Months]
• Endocrine (cortisol) response during the TSST [Time frame: Baseline, 10-Months, 20-Months]
• 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, 10-Months, 20-Months]

Secondary outcome measures (2)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• University of North Carolina at Chapel Hill — Chapel Hill

Identifiers

NCT: NCT07040449 · 24-1236 · R01MH136102

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗