Virtual Mentoring + Mental Health Videos for Teen Anxiety and Depression

Overseen By Mallory Dobias, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Appa Health

Disqualifiers: Psychotic disorders, Substance use, Self-harm, Suicidal ideation

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

Compensation: Varies

Number of Visits: Unknown

475 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but you should confirm with the trial organizers.

What data supports the idea that Virtual Mentoring + Mental Health Videos for Teen Anxiety and Depression is an effective treatment?

The available research does not provide specific data on the effectiveness of Virtual Mentoring + Mental Health Videos for Teen Anxiety and Depression. However, it does mention that mobile health apps for depression self-management can improve patient self-management, treatment engagement, and mental health outcomes, with 74% of apps having acceptable quality. This suggests that app-based interventions, like Virtual Mentoring + Mental Health Videos, have the potential to be effective. Additionally, app-based just-in-time interventions have been shown to decrease depressive symptoms, indicating that similar digital approaches can be beneficial. ^{1 2 3 4 5}

What safety data exists for the virtual mentoring and mental health video treatment for teen anxiety and depression?

The research indicates that mobile applications for mental health, including those targeting anxiety and depression, have shown potential in improving symptoms. However, the studies emphasize the need for further evaluations to fully integrate these tools into healthcare. Usability and effectiveness have been positively rated, but motivation to use the apps can be low, and further improvements are needed. Safety data specifically for the virtual mentoring and mental health video treatment is not directly mentioned, but the general findings suggest that these types of interventions are considered safe and beneficial, with a need for more comprehensive studies. ^{6 7 8 9 10}

Is the treatment Appa Complete, Appa Lite a promising treatment for teen anxiety and depression?

Yes, Appa Complete and Appa Lite are promising treatments for teen anxiety and depression. They use virtual mentoring and mental health videos, making it easier for teens to access help. These apps can provide support and teach useful skills to manage mental health challenges. ^{11 12 13 14 15}

What is the purpose of this trial?

This clinical trial evaluates Appa Health, a mental health smartphone and computer app for teenagers. Appa is built from two components. Component #1 shares short TikTok-style videos with teens to cover techniques from a science-backed mental health treatment, Cognitive Behavioral Therapy. These videos are designed by mental health experts and delivered by mental health influencers. Component #2 pairs teens with peer mentors with similar life experiences, who help guide teens through each week's video content. All peer mentors are trained and supervised by licensed mental health experts. The researchers believe Appa Health improves teens' mental health and well-being through teens' strengthened relationships and support from their mentor, as well as through the skills they gain through watching the videos. This study hopes to understand: (1) whether these Appa Health components improve teens' mental health and well-being, (2) how these components might improve teen outcomes, and (3) costs associated with each of these components. To answer these questions, the researchers will compare two versions of Appa support: Appa Complete and Appa Lite. Appa Complete involves pairing teens with mentors and sharing videos. Appa Lite involves only sharing videos with teens. First, the researchers will conduct a small version of this study to test procedures. Seventy-five teenagers (13-18 years old) with high depression or anxiety scores will be randomly given either: Appa Complete (mentoring + videos), Appa Lite (videos only), or a Waiting List Control. Based on the results of this smaller study, the researchers will change study procedures to improve teens' experiences and engagement in this research. After completing this smaller study, the researchers will run a larger version of the same study with 400 more teens. After teens are randomly given Appa Complete, Appa Lite, or a Waiting List Control, the researchers will test whether Appa's two treatment components improve teens' depression, anxiety, well-being, and other related outcomes. The researchers expect both Appa Complete and Appa Lite will improve teens' outcomes more than the Waiting List Control. The researchers also expect Appa Complete will improve teens' outcomes more than Appa Lite. The researchers will also measure costs associated with giving teens both treatment components and use this information to improve Appa's services for future teens.

Research Team

Robert Miller, JD

Principal Investigator

Appa Health

Michelle Kaufman, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for teens aged 13-18 in the U.S. with high anxiety or depression scores, who speak and comprehend English at least at a 5th grade level. Caregivers, mentors involved in the study, and those supervising mentors can also participate.

Inclusion Criteria

I can speak English.

I live in the United States.

I can read and understand English well enough for medical treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Study

Initial pilot study with 75 youth to optimize study procedures and participant retention

1 year

Effectiveness Trial

Large randomized controlled trial with 400 youth to study Appa costs and effectiveness

2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Appa Complete
• Appa Lite

Trial Overview The trial evaluates 'Appa Health', an app combining TikTok-style mental health videos and peer mentoring based on Cognitive Behavioral Therapy. It compares two versions: 'Appa Complete' (videos + mentoring) vs. 'Appa Lite' (only videos).

Participant Groups

Group I: Appa Complete Experimental Treatment 1 Intervention

Participants in this arm will be granted access to Appa Complete (i.e., weekly mentorship + CBT videos).

Group II: Waiting List Control Active Control 1 Intervention

Participants in this arm will be given a mental health resources packet. In 12 weeks (after the study period), they will be granted access to Appa Lite.

Group III: Appa Lite Active Control 1 Intervention

Participants in this arm will be granted access to Appa Lite (i.e., CBT videos without weekly mentorship).

Appa Complete is already approved in United States for the following indications:

Approved in United States as Appa Health for:

• Anxiety
• Depression
• Teen mental health support

Who Is Running the Clinical Trial?

Appa Health

Lead Sponsor

Trials

1

Recruited

480+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Findings from Research

The pilot study indicates that Advanced Practice Psychiatric Nurses (APPNs) are highly effective in improving clinical outcomes for clients with depression.

Clients reported high levels of satisfaction with the care provided by APPNs, suggesting that this model of care is beneficial for those seeking treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced practice psychiatric nurses' outcomes of care: a pilot study. Parrish, E., Peden, A., Staten, RT., et al.[2015]

Advanced practice psychiatric nurses (APPNs) are increasingly involved in treating depression, combining psychotherapy with prescriptive authority to address both psychological and neurobiological aspects of care.

A review of 14 quantitative studies indicates a need for more comprehensive outcomes research to evaluate the effectiveness of APPN-led depression treatments, as current literature is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of depressed clients: a review of current literature. Parrish, E., Peden, A.[2019]

A study involving 235 participants showed that the app-based intervention ImproveYourMood+ significantly reduced depressive symptoms and negative automatic thoughts over a 3-week period, with effects lasting up to one month after the intervention.

The most effective features of the app included mood monitoring, content delivery, and just-in-time prompts, indicating that comprehensive, multi-modal approaches may enhance user experience and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the features of an app-based just-in-time intervention for depression. Everitt, N., Broadbent, J., Richardson, B., et al.[2021]

A pilot advanced pharmacy practice experience (APPE) significantly increased fourth-year pharmacy students' knowledge about substance use disorder and harm reduction, with average scores rising from 55.2% to 81.5%.

Students' confidence in providing care related to these topics also improved dramatically, from 34.2% to 81.8%, highlighting the effectiveness of this APPE in preparing future pharmacists for real-world challenges in addiction medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description and Evaluation of a Pilot Advanced Pharmacy Practice Experience in Addiction Medicine. Loera, LJ., Hill, LG., Zagorski, CM., et al.[2023]

A systematic review of mobile health apps for depression found that 74% of the evaluated apps had acceptable quality, with 32% scoring 4.0 or higher on the Mobile Application Rating Scale (MARS), indicating their potential effectiveness.

These high-quality apps can enhance patient self-management and treatment engagement, suggesting they may be valuable tools for individuals with depression who face barriers to traditional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Commercially Available Mobile Apps for Depression Self-Management. Myers, A., Chesebrough, L., Hu, R., et al.[2022]

A systematic review of 22 studies over the past decade found that mobile applications significantly improve symptoms of depression and anxiety, demonstrating their effectiveness as a digital treatment tool.

Mobile apps promote patient empowerment and health literacy, suggesting they can enhance self-management of mental health conditions, but further research is needed to fully integrate them into healthcare practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological prescription: evaluation of the effectiveness of mobile applications to improve depression and anxiety. Systematic review. Planas, R., Yuguero, O.[2021]

Out of 3806 mental health apps identified, only 15 (0.39%) met the criteria for targeting anxiety, depression, or PTSD in youth, indicating a significant lack of quality options available for young users.

The overall quality of the eligible apps was moderate, with a mean score of 3.59 on the Mobile App Rating Scale, and only one app had been evaluated in a randomized controlled trial, highlighting the need for more rigorous scientific evaluation and development of mental health apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile-based interventions for common mental disorders in youth: a systematic evaluation of pediatric health apps. Domhardt, M., Messner, EM., Eder, AS., et al.[2021]

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 study demonstrated that integrating mental health apps into primary care is feasible and accepted by both providers and patients, with 66% of patients finding the apps helpful for managing stress and anxiety.

Behavioral health providers see value in using these apps but expressed a need for additional training to feel more confident in incorporating them into patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmenting Mental Health in Primary Care: A 1-Year Study of Deploying Smartphone Apps in a Multi-site Primary Care/Behavioral Health Integration Program. Hoffman, L., Benedetto, E., Huang, H., et al.[2023]

A study involving 132 children and 45 service providers found that a smartphone app designed for preventing youth anxiety received high usability ratings, indicating it is user-friendly and well-received by both groups.

The app's effectiveness is linked to its support information quality, suggesting that better guidance within the app leads to higher user satisfaction and understanding, which is crucial for its adoption in anxiety prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of a Smartphone Application to Support the Prevention and Early Intervention of Anxiety in Youth. Stoll, R., Pina, A., Gary, K., et al.[2020]

The Appa Health program, a 12-week smartphone app combining web-based mentoring with CBT skills taught through engaging videos, showed promising results in reducing symptoms of depression and anxiety among 14 teenagers, with 100% reporting feeling better after the program.

Participants found the program highly acceptable, with over 85% willing to recommend it to friends, indicating that trained mentors can effectively support youth mental health in a convenient and engaging way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Appa Health App for Youth Mental Health: Development and Usability Study. Giovanelli, A., Sanchez Karver, T., Roundfield, KD., et al.[2023]

Both youth and mental health providers agree that mobile health apps, particularly behavior-tracking apps, could enhance psychotherapy by making it more enjoyable and accessible.

Concerns were raised about the potential burden of using these apps, particularly regarding negative emotions and user fatigue, highlighting the need for user-friendly features to encourage long-term engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Youth and Provider Perspectives on Behavior-Tracking Mobile Apps: Qualitative Analysis. Armstrong, CC., Odukoya, EJ., Sundaramurthy, K., et al.[2021]

A systematic review of 24 publications found that mobile apps designed for mental health in adolescents lack sufficient research evidence to support their effectiveness, with only two small trials showing no significant impact on mental health outcomes.

Despite good acceptability and moderate usage of these apps, none of the analyzed apps had undergone rigorous research evaluation, highlighting the urgent need for robust studies to assess their safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental Health Mobile Apps for Preadolescents and Adolescents: A Systematic Review. Grist, R., Porter, J., Stallard, P.[2022]

A systematic review identified eight studies of internet-based programs for treating anxiety and depression in children and adolescents, with most interventions based on cognitive behavior therapy.

Six out of eight studies reported reductions in symptoms of anxiety and/or depression after the interventions, indicating early support for the effectiveness of these online programs, although more rigorous research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. Calear, AL., Christensen, H.[2022]

E-health interventions, particularly online cognitive behavioral therapy (CBT), have shown positive effects in reducing anxiety and depressive symptoms among adolescents aged 12 to 18, based on five randomized controlled trials.

Most of the trials focused on prevention rather than treatment, indicating a need for further research to enhance the effectiveness of internet-based programs for both preventing and treating depression in youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is e-health the answer to gaps in adolescent mental health service provision? O'Dea, B., Calear, AL., Perry, Y.[2022]

References

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Clinical outcomes of depressed clients: a review of current literature. [2019]

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Exploring the features of an app-based just-in-time intervention for depression. [2021]

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Description and Evaluation of a Pilot Advanced Pharmacy Practice Experience in Addiction Medicine. [2023]

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Evaluating Commercially Available Mobile Apps for Depression Self-Management. [2022]

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Technological prescription: evaluation of the effectiveness of mobile applications to improve depression and anxiety. Systematic review. [2021]

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Mobile-based interventions for common mental disorders in youth: a systematic evaluation of pediatric health apps. [2021]

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A Smartphone App for Promoting Mental Well-being and Awareness of Anxious Symptoms in Adolescents: A Pilot Cluster Randomized Controlled Trial. [2022]

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Augmenting Mental Health in Primary Care: A 1-Year Study of Deploying Smartphone Apps in a Multi-site Primary Care/Behavioral Health Integration Program. [2023]

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Usability of a Smartphone Application to Support the Prevention and Early Intervention of Anxiety in Youth. [2020]

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Mental Health Mobile Apps for Preadolescents and Adolescents: A Systematic Review. [2022]

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