RecruitingNot ApplicableNCT06072677

Adolescent Mood During Puberty and Testosterone

Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program

Sponsor

University of North Carolina, Chapel Hill

Enrollment

60 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

Adolescent Depression

Summary

Starting at puberty, female adolescents are nearly three-times more likely to develop internalizing disorders, like depression, while male adolescents are two-times more likely to develop externalizing disorders, like attention deficit hyperactivity disorder (ADHD). This divergence between the sexes during puberty suggests sex-specific pathways of risk and differential effects of sex hormones. The purpose of this research is to determine: 1) sex-specific neural and endocrine features of the pubertal transition that may mediate sex differences in adolescent mood disorders, and 2) the neurophysiological basis of susceptibility to hormone change during puberty.

Eligibility

Min Age: 11 YearsMax Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study explores how puberty, stress, and the hormone testosterone affect mood in adolescents aged 11–14. Participants use a mindfulness app to track their emotions and complete surveys to help researchers understand mental health changes during this important developmental period. **You may be eligible if...** - You are between 11 and 14 years old - You have your own phone and can download study apps - You have experienced a stressful life event in the past year, OR you have moderate depressive symptoms based on a questionnaire **You may NOT be eligible if...** - You have previously used the Healthy Minds Program - You have a regular meditation practice - You have a history of manic episodes, psychosis, or current suicidal thoughts - You are currently taking hormones or have an IUD - You are currently in another mental health intervention Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHealthy Minds Program

The Healthy Minds Program is a 4-week mobile program to improve coping and emotion regulation skills. It includes 4 training modules corresponding to key pillars of wellbeing: awareness(focused attention/awareness of thoughts/emotions), connection (empathy, compassion, social connection), insight (clarity of identify/experience) and purpose (applying values/motivations). The Healthy Minds Program includes 2 introductory audio lessons and guided meditations, and each 1-week module includes 2 podcast lessons (5-7 minutes) with psychoeducation and practical examples, and 3 guided meditations relevant to the module topic, for a total of 10 lessons and 14 guided meditations.

Locations(1)

Carolina Crossing B, Suite 1

Chapel Hill, North Carolina, United States

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NCT06072677