Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06072677

Conditions

Adolescent Depression

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

Interventions

Healthy Minds Program

Study Details

Brief 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.

Conditions

Adolescent Depression

Study ID

NCT06072677

Start date

Aug 24, 2023

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Healthy Minds Program

Participants in this group will begin the Healthy Minds Program immediately following the 4-week baseline period.

other: Waitlist Control

After the 4-week baseline period, participants in the waitlist control condition will wait an additional 4 weeks before starting the Healthy Minds Program.

Interventions

Healthy 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.

Primary outcome measure

  • CES-DC Score Over Time [ Time Frame: up to Week 8 ]

Central Contacts and Locations

Central contacts

Kayla Jensen, BS

919-445-6815nerdlab@unc.edu

Locations

Carolina Crossing B, Suite 1

Recruiting

Chapel Hill, North Carolina, United States, 27517

Contacts

Kayla Jensen, BS

919-445-6815nerdlab@unc.edu

Principal Investigator:

Elizabeth Andersen, PhD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Keywords

  • Puberty
  • Depression
  • Mood disturbance
  • Adolescence
  • Stress
  • Peripubertal Transition
  • Hormones
  • EEG
  • Sex differences

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-01-14.