Healthy Minds Program for Adolescent Depression

(AMPT Trial)

Overseen By Kayla Jensen, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Exogenous hormones, IUD, others

Disqualifiers: Manic episodes, Psychotic symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{4 10 11 12 13}

Research Team

Elizabeth Andersen, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Waitlist Control Experimental Treatment 1 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 Program Experimental Treatment 1 Intervention

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

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A cognitive-behavioral program (CB) significantly reduced depressive symptoms in adolescents compared to both a nonspecific control and a no-intervention control, as shown by lower scores on the Children's Depression Inventory at the 4-month follow-up.

The study involved 518 high school students over a 10-week intervention period, highlighting the potential effectiveness of structured cognitive-behavioral approaches in preventing depression among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a cognitive-behavioral program for the prevention of depression in adolescents compared with nonspecific and no-intervention control conditions. Pössel, P., Martin, NC., Garber, J., et al.[2018]

The CATCH-IT program is a unique Internet-based intervention designed to prevent depression in adolescents, currently being tested in a randomized clinical trial with 234 enrolled adolescents, aiming for a total of 400 participants.

This trial is significant as it connects at-risk youth with self-directed prevention programs in primary care settings, potentially offering a scalable model for addressing adolescent depression through technology and human support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial. Gladstone, TG., Marko-Holguin, M., Rothberg, P., et al.[2023]

A systematic review of 130 articles involving 45,924 participants found that school-based psychological prevention programs have small but significant effects in reducing symptoms of depression (effect size g = 0.21) and anxiety (effect size g = 0.18) immediately after intervention.

Targeted prevention programs for at-risk youth showed greater effectiveness compared to universal programs, suggesting that tailoring interventions to specific needs can enhance their impact on mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based depression and anxiety prevention programs: An updated systematic review and meta-analysis. Werner-Seidler, A., Spanos, S., Calear, AL., et al.[2021]

A review of 81 studies involving 31,794 school students found that school-based psychological programs for preventing depression and anxiety had small but significant effects immediately after the intervention (g=0.23 for depression and g=0.20 for anxiety).

Targeted prevention programs were more effective than universal programs for depression, while the effectiveness for anxiety was similar across both types; interventions delivered by external professionals showed better outcomes for depression compared to those delivered by school staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based depression and anxiety prevention programs for young people: A systematic review and meta-analysis. Werner-Seidler, A., Perry, Y., Calear, AL., et al.[2022]

The Mind My Mind (MMM) cognitive behavioral therapy (CBT) was found to be particularly effective for youths aged 6-16 with existing mental disorders, showing a significant reduction in the impact of mental health problems compared to those without such disorders.

Factors like comorbidity and longer duration of untreated mental health issues were linked to better treatment outcomes, indicating that MMM is especially beneficial for youths facing more severe or prolonged mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rimvall, MK., Vassard, D., Nielsen, SM., et al.[2023]

A school-based program where psychiatry residents educated adolescents on mental health topics received positive feedback, highlighting concerns about drugs, depression, suicide, and family issues.

The program not only benefited the students but also provided valuable experience for the residents in agency consultation and secondary prevention strategies, indicating a dual benefit for both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A residents' program for educating adolescents about mental health issues. Coverdale, JH., Battaglia, J., Bushong, CP.[2021]

Adolescents are often underserved in mental health care for depression, as they typically do not seek help from pediatricians, highlighting a gap in the traditional mental health system's ability to meet their developmental needs.

The adolescent comprehensive health care clinic model, which integrates primary care and mental health services, shows promise in effectively addressing early-stage depression in teens, but further research and funding are needed to enhance and expand these services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognizing and responding to adolescent depression. King, SR.[2019]

A 16-week randomized clinical trial involving 63 adolescents showed that interpersonal psychotherapy modified for adolescents (IPT-A) significantly reduced depression symptoms and improved overall functioning compared to treatment as usual (TAU).

The study found that IPT-A led to better outcomes on multiple measures, including the Hamilton Depression Rating Scale and the Children's Global Assessment Scale, demonstrating its effectiveness in school-based health clinics for treating adolescent depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents. Mufson, L., Dorta, KP., Wickramaratne, P., et al.[2022]

The EMERALD collaborative care program significantly improved depression outcomes for adolescents, showing an 11% higher remission rate and a 14% higher treatment response compared to standard care, based on a study of 162 participants.

This study highlights the effectiveness of integrating mental health care into primary care settings, suggesting that such models can provide better support for adolescents struggling with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness in Regular Practice of Collaborative Care for Depression Among Adolescents: A Retrospective Cohort Study. Shippee, ND., Mattson, A., Brennan, R., et al.[2022]

A prevention program aimed at enhancing resilience among 171 at-risk Icelandic adolescents significantly reduced the incidence of major depression and dysthymia compared to a control group that received standard assessments.

The study highlights that school personnel can effectively implement such prevention programs, suggesting a practical approach to addressing mental health issues in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of depression among Icelandic adolescents. Arnarson, EO., Craighead, WE.[2009]

References

1. England pubmed.ncbi.nlm.nih.gov

Systematic review of school-based prevention and early intervention programs for depression. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Improving care for depression and suicide risk in adolescents: innovative strategies for bringing treatments to community settings. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A controlled trial of a school-based Internet program for reducing depressive symptoms in adolescent girls. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

School-based depression and anxiety prevention programs: An updated systematic review and meta-analysis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

School-based depression and anxiety prevention programs for young people: A systematic review and meta-analysis. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

A residents' program for educating adolescents about mental health issues. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Recognizing and responding to adolescent depression. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Effectiveness in Regular Practice of Collaborative Care for Depression Among Adolescents: A Retrospective Cohort Study. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Prevention of depression among Icelandic adolescents. [2009]