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

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

Inclusion Criteria3

  • Between the ages of 11 and 14
  • Have their own personal mobile device and capability to download the MyCap and Healthy Minds apps
  • Experienced a stressful life event within the last year, or endorse moderate depression (defined by a CES-DC score 16 or higher)

Exclusion Criteria5

  • Previous experience with the Healthy Minds Program
  • Regular meditation practice
  • Current or history of manic episodes, psychotic symptoms, or current suicidal intent
  • Taking any form of exogenous hormones or intrauterine device (IUD) within one month of participation in the study
  • Taking medications that directly alter cardiovascular or neurological function

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