60 Participants Needed

Healthy Minds Program for Adolescent Depression

(AMPT Trial)

KJ
Overseen ByKayla Jensen, BS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that directly alter cardiovascular or neurological function, as well as any form of exogenous hormones or intrauterine device (IUD) within one month of participation.

Is the Healthy Minds Program for Adolescent Depression safe for humans?

The reviewed school-based programs, which may include similar approaches to the Healthy Minds Program, generally show small effects in reducing depression and anxiety symptoms in adolescents, with no significant safety concerns reported. These programs are often delivered by mental health professionals and are considered safe for use in school settings.12345

How does the Healthy Minds Program for Adolescent Depression treatment differ from other treatments for this condition?

The Healthy Minds Program is unique because it focuses on a cognitive-behavioral approach, which involves teaching adolescents skills to manage their thoughts and behaviors to prevent depression. This program is delivered in a school setting, making it more accessible and integrated into the students' daily environment, unlike traditional treatments that often require visits to clinics or therapists.678910

What data supports the effectiveness of the Healthy Minds Program treatment for adolescent depression?

Research shows that cognitive-behavioral programs, similar to the Healthy Minds Program, can effectively reduce depressive symptoms in adolescents. A study found that adolescents participating in a cognitive-behavioral program had significantly lower depression scores compared to those who did not receive the intervention.56111213

Who Is on the Research Team?

EA

Elizabeth Andersen, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

I have never had manic episodes, psychosis, or current thoughts of suicide.
I have not used hormones or an IUD in the last month.
I am on medication that affects my heart or brain function.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a 4-week baseline period before starting the intervention

4 weeks

Treatment

Participants in the experimental group begin the Healthy Minds Program immediately after the baseline period, while the waitlist control group waits an additional 4 weeks before starting the program

4 weeks

Follow-up

Participants are monitored for changes in CES-DC scores to assess depressive symptoms

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Healthy Minds Program
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Waitlist ControlExperimental Treatment1 Intervention
Group II: Healthy Minds ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

Foundation of Hope, North Carolina

Collaborator

Trials
18
Recruited
670+

Published Research Related to This Trial

A systematic review of 42 randomized controlled trials found that school-based programs, particularly those using cognitive behavioral therapy (CBT), are effective in reducing depressive symptoms in students, especially those already showing elevated levels of depression.
The effectiveness of these programs varied widely, with effect sizes ranging from 0.21 to 1.40, and programs led by teachers or those using attention control conditions showed fewer significant effects, highlighting the need for further research in these areas.
Systematic review of school-based prevention and early intervention programs for depression.Calear, AL., Christensen, H.[2022]
The review highlights that there are effective treatment models and service delivery strategies available for addressing depression and suicidality in adolescents, emphasizing the importance of evidence-based care.
It calls for future research and quality improvement initiatives to better connect scientific findings with community practices, aiming to enhance mental health and well-being among young people.
Improving care for depression and suicide risk in adolescents: innovative strategies for bringing treatments to community settings.Asarnow, JR., Miranda, J.[2023]
The self-directed Internet intervention MoodGYM significantly reduced depressive symptoms in high school girls over a 20-week period, particularly benefiting those with higher initial depression scores, showing a moderate effect size (Cohen's d = 0.46).
Despite its effectiveness, only about 30% of participants completed three or more modules of MoodGYM, indicating challenges in adherence to online depression programs, which may limit their overall impact.
A controlled trial of a school-based Internet program for reducing depressive symptoms in adolescent girls.O'Kearney, R., Kang, K., Christensen, H., et al.[2022]

Citations

Systematic review of school-based prevention and early intervention programs for depression. [2022]
Improving care for depression and suicide risk in adolescents: innovative strategies for bringing treatments to community settings. [2023]
A controlled trial of a school-based Internet program for reducing depressive symptoms in adolescent girls. [2022]
A randomized controlled trial of a cognitive-behavioral program for the prevention of depression in adolescents compared with nonspecific and no-intervention control conditions. [2018]
An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial. [2023]
School-based depression and anxiety prevention programs: An updated systematic review and meta-analysis. [2021]
School-based depression and anxiety prevention programs for young people: A systematic review and meta-analysis. [2022]
Effect modification of an effective transdiagnostic cognitive behavioral psychotherapy in youths with common mental health problems: Secondary analyses of the randomized mind-my-mind trial. [2023]
A residents' program for educating adolescents about mental health issues. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Recognizing and responding to adolescent depression. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness in Regular Practice of Collaborative Care for Depression Among Adolescents: A Retrospective Cohort Study. [2022]
Prevention of depression among Icelandic adolescents. [2009]
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