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Healthy Minds Program for Adolescent Depression (AMPT Trial)

N/A

Recruiting

Led By Elizabeth Andersen, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 11 and 14

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 8

Awards & highlights

AMPT Trial Summary

This trial will look at why adolescent girls are more likely to have depression and boys ADHD, and what factors may be at play during puberty.

Who is the study for?

This trial is for adolescents aged 11-14 who have faced a stressful event in the past year or show moderate depression. They must own a mobile device to download necessary apps. It's not for those with prior Healthy Minds Program experience, regular meditation practice, history of manic or psychotic symptoms, current suicidal intent, hormone treatments within the last month, or medications affecting heart or brain function.Check my eligibility

What is being tested?

The study investigates how puberty affects mood disorders differently in males and females by looking at brain activity and hormone levels. Participants will use the Healthy Minds Program app designed to track these changes during their pubertal transition.See study design

What are the potential side effects?

Since this trial involves non-invasive monitoring through an app rather than medication, traditional side effects are not expected. However, participants may experience discomfort from reflecting on personal emotions while using the app.

AMPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 11 and 14 years old.

AMPT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CES-DC Score Over Time

AMPT Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlist ControlExperimental Treatment1 Intervention

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

Group II: Healthy Minds ProgramExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Healthy Minds Program

2022

N/A

~300

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Foundation of Hope, North CarolinaOTHER

15 Previous Clinical Trials

492 Total Patients Enrolled

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,982 Total Patients Enrolled

Elizabeth Andersen, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

2 Previous Clinical Trials

103 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any characteristics that make certain individuals more suitable for taking part in this trial?

"Patients aged between 11 and 14 with adolescent depression are able to apply to this medical trial, which is hoping to recruit a total of 60 people."

Answered by AI

Is this clinical experiment including participants over the age of 80?

"According to the eligibility requirements, this clinical trial is limited to children between 11 and 14 years old. In addition, 197 studies are recruiting participants younger than 18 and 898 for those over 65."

Answered by AI

Are recruitment efforts still open for this scientific experiment?

"According to clinicaltrials.gov, this trial is presently recruiting participants. The research was initially listed on August 24th 2023 and underwent an update as recently as October 2nd 2023."

Answered by AI

What is the upper limit for participants involved in this experiment?

"Affirmative. Evidence found on clinicaltrials.gov asserts that this medical study is presently searching for volunteers, with the initial posting date of August 24th 2023 and its most recent edition being October 2nd 2023. The trial requires 60 participants from a solitary site to be enrolled in order to advance forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adolescent Mood During Puberty and Testosterone

2023. "Adolescent Mood During Puberty and Testosterone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072677.

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