Adolescent Mood During Puberty and Testosterone (AMPT)

University of North Carolina (UNC)

Status: Enrolling

Conditions: Adolescent Depression

Treatments: Behavioral: Healthy Minds Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06072677

23-1336

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 11 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Healthy Minds Program

Experimental group

Description:

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

Treatment:

Behavioral: Healthy Minds Program

Waitlist Control

Other group

Description:

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

Treatment:

Behavioral: Healthy Minds Program