Well-being Training for Adolescent Depression

Overseen By Matthew Hirshberg, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: High school diploma, Meditation, Suicidal thoughts, Psychosis, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a meditation app, the Healthy Minds Program App, can assist teenagers experiencing higher levels of depression. Participants will use the app for 20 weeks to determine its effect on mood improvement. The trial includes a comparison group using a water-tracking app, the Hydro Coach App, to ensure any results are attributable to the meditation app. High school students who regularly feel down or blue might be suitable candidates. As an unphased trial, this study provides a unique opportunity for teens to explore innovative methods to enhance their mental well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on a psychotropic medication, you must have been on a stable dose for at least 4 weeks before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Healthy Minds Program app is generally safe for users. In past studies, people using the app reported feeling less stressed and anxious, with no major negative effects. For example, using the app for just 5 minutes a day led to a 28% drop in stress and an 18% drop in anxiety.

Importantly, no reports of serious side effects have emerged from using the app. As a meditation-based tool designed to boost well-being, it is less likely to cause harm compared to treatments involving medication. Overall, the app appears well-tolerated and safe for managing symptoms of depression. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Healthy Minds Program (HMP) App because it offers a unique, meditation-based approach to improving well-being in adolescents with depression. Unlike traditional treatments like medication and therapy, which often require in-person appointments, this app provides a convenient, smartphone-based solution that can be accessed anytime and anywhere. The app focuses on mindfulness and meditation, which are gaining attention for their potential to enhance mental health by promoting relaxation and emotional regulation. This innovative delivery method could make mental health support more accessible and appealing to tech-savvy teens.

What evidence suggests that this trial's treatments could be effective for adolescent depression?

Research has shown that the Healthy Minds Program app, available to participants in this trial, can reduce distress and improve well-being. One study found that the app lowered depression, anxiety, and even suicidal thoughts among college students, suggesting potential benefits for teenagers as well. The app employs meditation and lessons to train the mind, aiming to enhance focus and reduce stress. This approach is believed to build skills crucial for managing depression symptoms. These findings suggest the app could be a valuable tool for teenagers dealing with depression. Meanwhile, participants in the Hydro Coach active control group will use a water tracking app that prompts users to log daily liquid consumption and provides optimized hydration recommendations. ^{2 3 5 6 7}

Who Is on the Research Team?

Matthew Hirshberg, PhD

Principal Investigator

Center for Healthy Minds, UW Madison

Are You a Good Fit for This Trial?

This trial is for English-speaking teens aged 14-19 who are experiencing symptoms of depression and currently in high school or equivalent grade level. They must be stable on any psychotropic medications for at least 4 weeks, able to consent, and not practicing meditation weekly or have used the apps being tested.

Inclusion Criteria

Proficient in English

If PROMIS Depression Scale T-score greater than or equal to 70, must be under current care and provide provider contact information

I am willing and able to follow all study requirements.

Exclusion Criteria

Has received a high school diploma or a high school equivalency diploma (HSED or GED)

Weekly or more frequent meditation practice

Prior use of the water tracking app

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized into either the Healthy Minds Program intervention group or a water tracking active control group, using different mobile health apps for eight weeks.

8 weeks

Assessments at pre-intervention, weeks 2, 4, 6, and 8

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments at week 20.

12 weeks

1 visit (in-person or virtual) at week 20

Open-label extension

Participants receive access to the app they were not assigned to after follow-up.

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Minds Program App
• Hydro Coach App

Trial Overview

The study tests if the Healthy Minds Program app can alleviate depressive symptoms in adolescents compared to a water tracking app called Hydro Coach. Participants will use these apps over a period of 20 weeks to determine their effectiveness.

How Is the Trial Designed?

Group I: Healthy Minds Program (HMP) App Experimental Treatment 1 Intervention

The HMP is a smartphone meditation-based well-being training.

Group II: Hydro Coach active control group (HC) Active Control 1 Intervention

The water tracking app is a publicly available, user-designed hydration app that prompts users to enter in daily liquid consumption and provides optimized hydration recommendations based on user input.

Healthy Minds Program App is already approved in United States, European Union for the following indications:

Approved in United States as Healthy Minds Program App for:

• General well-being
• Stress reduction
• Anxiety management
• Depression management

Approved in European Union as Healthy Minds Program App for:

• General well-being
• Stress reduction
• Anxiety management
• Depression management

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

New quality standards recommend that pediatricians screen adolescents for depression and create follow-up plans for those who test positive, which may lead to an increase in referrals and the need for effective interventions.

The study highlights the potential of lifestyle medicine interventions as evidence-based tools for managing adolescent depression, which can complement traditional treatments like psychotherapy and medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Back to Basics: Lifestyle Interventions for Adolescent Depression. Benheim, TS., Dalal, M., Holcomb, JM., et al.[2023]

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]

The study involving 112 adolescents aged 12-16 demonstrated that the Computerised-CBT (C-CBT) program significantly improved symptoms of depression and anxiety compared to a waiting list, with benefits maintained at 3 and 6 months follow-up.

C-CBT also led to fewer school absences in the month following treatment, indicating practical benefits beyond mental health improvements, although it did not affect academic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised CBT for depressed adolescents: Randomised controlled trial. Smith, P., Scott, R., Eshkevari, E., et al.[2022]

Digital health interventions, particularly computerized cognitive behavioral therapy, have shown effectiveness in treating anxiety and depression among adolescents and young people, but other digital methods remain inconclusive.

Interventions that include in-person elements, such as support from professionals or peers, tend to be more effective and have better adherence rates compared to fully automated digital solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence on Digital Mental Health Interventions for Adolescents and Young People: Systematic Overview. Lehtimaki, S., Martic, J., Wahl, B., et al.[2021]

The computerized cognitive behavioral therapy (cCBT) program, The Journey, was found to be feasible and acceptable for use among adolescents, with a high completion rate of 94%.

Adolescents receiving cCBT showed significantly greater improvement in depression symptoms compared to those in the placebo group, with a mean change of 17.6 on the Child Depression Rating Scale, indicating its efficacy in treating depression in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot double blind randomized placebo controlled trial of a prototype computer-based cognitive behavioural therapy program for adolescents with symptoms of depression. Stasiak, K., Hatcher, S., Frampton, C., et al.[2022]

The smartphone app designed to promote mental well-being did not significantly increase 'Sharing, Mind, and Enjoyment' (SME) behaviors among adolescents, with only 11.2% of students using it with their parents, but it did enhance awareness of anxious symptoms significantly at both 1 and 3 months follow-up.

Post hoc analysis revealed that students who used the app with their parents showed a notable increase in SME-related behaviors at 3 months compared to the control group, suggesting that parental involvement may enhance the app's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone App for Promoting Mental Well-being and Awareness of Anxious Symptoms in Adolescents: A Pilot Cluster Randomized Controlled Trial. Sun, Y., Wang, MP., Ho, SY., et al.[2022]

The Whitu app, designed to improve mental health in youth, showed significant reductions in anxiety and stress after 2 weeks, and improvements in well-being and depression after 6 weeks, based on a pilot study with 20 participants aged 16-25.

Qualitative feedback from 21 participants highlighted the app's usability and cultural acceptability, leading to modifications before a larger randomized controlled trial (RCT) to further assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a well-being app to support New Zealand young people during the COVID-19 pandemic. Serlachius, A., Boggiss, A., Lim, D., et al.[2022]

The 'Stressbusters' program, an interactive computer-based cognitive behavioral therapy (CBT) designed for teenagers with mild to moderate depression, showed significant efficacy, reducing the number of participants meeting criteria for a depressive disorder from 95% to 22% after treatment.

Participants also experienced notable improvements in global functioning and reductions in anxiety and depressive symptoms, with these benefits maintained at a 3-month follow-up, indicating the program's potential as a valid treatment option for adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized CBT for adolescent depression ("Stressbusters") and its initial evaluation through an extended case series. Abeles, P., Verduyn, C., Robinson, A., et al.[2022]

The MoodHwb program, designed with input from young people at risk of depression, aims to support their mood and well-being, and is currently being refined based on user feedback before a larger trial.

A multicentre feasibility randomized controlled trial will assess the acceptability and effectiveness of MoodHwb compared to a digital information pack, involving up to 120 participants aged 13-19, with outcomes measured two months post-randomization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol. Bevan Jones, R., Merry, S., Stallard, P., et al.[2023]

The CATCH-IT online intervention effectively reduces depressive symptoms in adolescents, showing significant improvement over 24 months, similar to an online health education program.

Both CATCH-IT and health education led to significant reductions in depressive symptoms, but CATCH-IT also showed a notable effect on reducing anxiety, highlighting its potential for broader mental health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of an Internet-Based Adolescent Depression Prevention Intervention in Primary Care: Internalizing Symptom Outcomes. Gladstone, T., Buchholz, KR., Fitzgibbon, M., et al.[2021]

The Adolescent Depression Awareness Program (ADAP) was created to improve education about depression in high schools, aiming to reduce the risks of depression and suicide among adolescents.

A survey of 5,645 high school students revealed that while they had some basic knowledge about depression, there were significant gaps in their understanding of treatment options and how to identify symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of adolescents' knowledge about depression. Hess, SG., Cox, TS., Gonzales, LC., et al.[2022]

The IT-based program 'DepisNet' was tested in a study with 151 adolescents across two schools in Finland, but it did not show statistically significant improvements in depression, quality of life, self-esteem, or self-efficacy compared to a control group.

Despite the lack of significant differences, the intervention group showed a more positive change in quality of life, suggesting potential benefits, and the program was well-received in terms of adherence and acceptance among students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact and Feasibility of Information Technology to Support Adolescent Well-Being and Mental Health at School: A Quasi-Experimental Study. Anttila, M., Lantta, T., Ylitalo, M., et al.[2022]

The 'Cuida tu Ánimo' program, aimed at preventing and intervening in adolescent depression, showed moderate to high acceptance among 199 participants from Chile and Colombia, but adherence to the program was lower than expected.

Post-intervention results indicated a reduction in depressive and anxious symptoms among Chilean adolescents, while no significant changes were observed in Colombian adolescents, highlighting the need for customization and context-specific strategies to improve effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of "Cuida tu Ánimo" (Take Care of Your Mood): An Internet-Based Program for Prevention and Early Intervention of Adolescent Depression in Chile and Colombia. Martínez, V., Espinosa-Duque, D., Jiménez-Molina, Á., et al.[2021]

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