Stress Trajectories and Anhedonia in Adolescence Research Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-15
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 13-15 years old at study entry
Ability to understand and sign an assent form
Meets study hearing and vision requirements
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Montreal Imaging Stress Task
BehavioralPsychosocial 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
BehavioralPsychosocial 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.
Treatment groups
192 Participants
are divided into 1 treatment groupGroup A: Adolescent TeenagersExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 10-months, 20-months2
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%.
Time frame
Baseline, 10-Months, 20-Months3
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.
Time frame
Baseline4
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.
Time frame
Baseline, 10-Months, 20-MonthsSecondary outcomes
1
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.
Time frame
Baseline, 10-months, 20-months2
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.
Time frame
Baseline, 10-months, 20-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov