Qoyangnuptu Intervention App for Mental Health Wellness

Overseen By Marissa Adams, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Northern Arizona University

Disqualifiers: Age, Community, Smartphone, Internet

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mobile health app can support mental health and community engagement in American Indian/Alaska Native youth. Participants will use the Qoyangnuptu Intervention (QI) App to log their mood, practice mindfulness, and engage in cultural activities. The researchers aim to determine if the app can improve mental well-being and community engagement by providing daily guidance from peer mentors. This trial suits individuals aged 14-25 who belong to a Southwestern Tribal community and can access the internet on their smartphones daily.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mental health support for the community.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app for mental health support, so it's unlikely that medication changes are required.

What prior data suggests that the Qoyangnuptu Intervention App is safe for mental health wellness?

Research shows that mental health apps, such as the Qoyangnuptu Intervention App, are generally safe. Studies on similar apps have found no major side effects. Most users find these apps easy to use, and they often help reduce stress and improve mental well-being. This is encouraging for anyone considering participation in trials like this one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Qoyangnuptu Intervention (QI) App because it offers a new approach to mental health wellness by utilizing digital technology. Unlike traditional therapies that often require in-person sessions with a healthcare provider, the QI App can be used daily at home for just 5-10 minutes, providing convenient and consistent support. This app-based intervention is designed to empower users, potentially making mental health care more accessible and less stigmatizing, especially for younger individuals who are comfortable with digital solutions. By integrating mental health support into a digital format, the QI App could revolutionize how mental well-being is managed in everyday life.

What evidence suggests that the QI App is effective for mental health wellness?

Research shows that mobile health apps like the Qoyangnuptu Intervention (QI) App, which participants in this trial will use, can positively affect mental health by encouraging mindfulness practices. These practices include activities like guided breathing and meditation, which are linked to reducing stress and improving mood. Studies on similar apps indicate that structured mindfulness activities can help users better manage their emotions. The QI App is also designed to be culturally relevant, incorporating Hopi cultural activities to potentially enhance its effectiveness for American Indian/Alaska Native communities. Although specific data on the QI App's effectiveness is still being collected, early findings suggest it has promising potential to improve mental well-being. ^{1 2 3 6 7}

Who Is on the Research Team?

Morgan Vigil-Hayes, PhD

Principal Investigator

Northern Arizona University

Are You a Good Fit for This Trial?

This trial is for individuals aged 14-25 who belong to a Southwestern Tribal community, can access the internet daily with a smartphone, and have a device that can run the Qoyangnuptu Intervention (QI) App.

Inclusion Criteria

I own a smartphone that can run the QI App.

I can access the Internet with a smartphone daily.

I am a member of a Southwestern Tribal community.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consent Process

Participants review study details, answer questions, and obtain informed consent via Zoom or in-person meeting

1 week

Treatment

Participants use the QI App daily for 5-10 minutes over 6 weeks, logging mood and stress, practicing mindfulness, and engaging in cultural activities

6 weeks

Follow-up

Participants complete a user questionnaire and participate in focus groups 12 weeks after starting the app

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Qoyangnuptu Intervention (QI) App

Trial Overview The study tests the QI App's effectiveness in promoting mental health wellness among American Indian/Alaska Native youth. It includes daily app use, peer mentor guidance, mood tracking, mindfulness practices, and cultural activities like running.

How Is the Trial Designed?

Group I: QI App Users Experimental Treatment 1 Intervention

Participants will be asked to use the QI App once per day for 5-10 minutes per day for 6 weeks.

Group II: Parents/Guardians of QI App Users Experimental Treatment 1 Intervention

Parents/guardians of QI App users will be aware that their child is using the QI App once per day for 5-10 minutes per day for 6 weeks.

Who Is Running the Clinical Trial?

Northern Arizona University

Lead Sponsor

Trials

36

Recruited

6,300+

Published Research Related to This Trial

The systematic review analyzed 22 articles on 8 mental health apps developed by the Veterans Affairs and Department of Defense, highlighting their feasibility and acceptability among users, including patients and clinicians.

Evidence supporting the efficacy and effectiveness of these apps is limited, with only two apps (PTSD Coach and Virtual Hope Box) showing promising results, suggesting that clinicians should be cautious in promoting these tools until more robust evidence is available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veterans Affairs and the Department of Defense mental health apps: A systematic literature review. Gould, CE., Kok, BC., Ma, VK., et al.[2019]

A review of 28 popular smartphone apps for depression found that none utilized just-in-time adaptive intervention (JITAI) mechanisms, which are designed to provide tailored support based on an individual's state of vulnerability and receptivity.

Most apps relied on self-reported outcomes (71%) but did not use these measurements to customize content or timing, indicating a significant gap in leveraging the potential of JITAI mechanisms to enhance the effectiveness of depression interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review. Teepe, GW., Da Fonseca, A., Kleim, B., et al.[2023]

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 smartphone app 'MCT & More' showed a small but positive effect on self-competence among 159 inpatients with depression after discharge, although it did not significantly improve overall self-esteem, quality of life, or depressive symptoms over 4 weeks.

User engagement with the app was influenced by positive attitudes towards mobile interventions and treatment expectations, suggesting that user perception may play a key role in the effectiveness of such digital tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile-based aftercare intervention to increase self-esteem in inpatients diagnosed with depression: A randomized controlled trial. Bruhns, A., Baumeister, A., Demeroutis, G., et al.[2023]

In a study involving 218 patients with moderately severe to severe depression, participation in the therapist-supported Meru Health Program led to a significant reduction in depressive symptoms, with an average decrease of 8.30 points on the PHQ-9 scale, indicating strong efficacy.

Approximately 34% of patients with moderately severe symptoms and 29.9% of those with severe symptoms showed a response to the intervention, achieving at least a 50% reduction in their PHQ-9 scores, suggesting that the program may be effective for those with more severe depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant reduction in depressive symptoms among patients with moderately-severe to severe depressive symptoms after participation in a therapist-supported, evidence-based mobile health program delivered via a smartphone app. Forman-Hoffman, VL., Nelson, BW., Ranta, K., et al.[2021]

The Journey to the West app is specifically designed for Asian international college students, addressing their unique mental health challenges, such as higher rates of depression and stigma around seeking help, which are often overlooked in generic stress management apps.

By integrating Cognitive Behavioral Therapy techniques into a culturally relevant role-playing game format, the app aims to enhance engagement and effectiveness in stress management, promoting social integration and resilience among its users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Cultural Contexts in the Management of Stress via Narrative and Mobile Technology. Lee, MD., Kang, X., Hanrahan, N.[2022]

A 30-day field trial of a personal mental healthcare application demonstrated significant improvements in mood scores among participants, indicating its potential effectiveness in managing mental health.

The study highlights the application’s ability to help users self-monitor and regulate their behavior, suggesting a promising approach for preventive mental healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing behavioral self-regulation application for preventive personal mental healthcare. Hirano, M., Ogura, K., Kitahara, M., et al.[2020]

Mobile applications have been shown to effectively reduce symptoms in patients with mental disorders, including depression, mania, and psychosis, based on a systematic review of 14 randomized controlled trials involving 1307 patients.

Interventions that include features like feedback, notifications, and data tracking lead to better outcomes, suggesting that well-designed mobile apps can serve as valuable supplements to traditional clinical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile applications for patients with severe mental illness: A meta-analysis of randomized controlled trials. Kim, SK., Lee, M., Jeong, H., et al.[2022]

Psychological health mobile applications are being used for various purposes, including self-management, skills training, and symptom tracking, highlighting their versatility in supporting mental health.

Current evidence suggests that these apps can be effective tools in psychological health practice, but there is a need for careful evaluation of their quality and clinical utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps for psychological health: A brief state of the science review. Bush, NE., Armstrong, CM., Hoyt, TV.[2019]

A study involving 85 participants using a mental health app for 12 weeks showed significant reductions in anxiety and depression, with anxiety decreasing at a statistically significant level (p = 0.003) and depression also showing improvement (p = 0.043).

While the app effectively reduced anxiety and depression, it did not significantly change emotional labor or overall well-being, indicating that while the app is a useful tool for mental health management, further modifications are needed for sustained effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Effects of Cognitive Behavior-Based Healing Programs Using Mobile Apps. Hwang, WJ., Jo, HH.[2021]

The Anchored app, designed to reduce depressive symptoms in stressed working adults, showed significant improvements in depression and anxiety levels after a 30-day program, with reductions in likely new onset depression from 24% to 6%.

Participants reported high usability and acceptability of the app, with 93.2% finding it easy to use, indicating that mobile app interventions can be a promising tool for addressing mental health issues in the workplace.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Evaluation of a Smartphone Application for Workplace Depression. Collins, DAJ., Harvey, SB., Lavender, I., et al.[2020]

A meta-analysis of 19 trials involving 3681 participants found that standalone smartphone apps significantly reduced symptoms of depression and smoking behavior, with effect sizes indicating moderate efficacy (Hedges' g = 0.33 for depression and g = 0.39 for smoking).

However, the analysis did not find significant effects for anxiety, suicidal ideation, self-injury, or alcohol use, suggesting that while some apps may help with specific issues, they cannot be recommended as standalone treatments for mental health based on current evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone smartphone apps for mental health-a systematic review and meta-analysis. Weisel, KK., Fuhrmann, LM., Berking, M., et al.[2020]

In a pilot study involving 33 veterans, the Moving Forward app was tested alongside problem-solving therapy (PST) and showed high satisfaction and reductions in depression, anxiety, and stress among participants.

Veterans using the app reported effective skills practice and found it valuable, suggesting that the app could help reduce barriers to mental health care in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Problem-Solving Therapy With Smartphone Technology: A Pilot Randomized Controlled Trial. Grubbs, KM., Abraham, TH., Pyne, JM., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-mental-health-wellness-1-3-2024-4e43e

Qoyangnuptu Intervention App for Mental Health Wellness The study tests the QI App's effectiveness in promoting mental health wellness among American Indian/Alaska Native youth.

2. trial.medpath.com trial.medpath.com/clinical-trial/0d8d519434496f0b/nct06254924-qoyangnuptu-mobile-health-app-adolescents

Qoyangnuptu Intervention (QI) App - MedPath This research seeks to investigate the impact that a mobile phone app that teaches mindfulness and provides opportunities for mindfulness practice might help ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06254924/qoyangnuptu-qoyangnuptu-intervention-qi-app

Qoyangnuptu Intervention (QI) App The goal of this clinical trial is to learn about the impacts of using a mobile health app, the Qoyangnuptu Intervention App (QI App) a

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06254872?term=AREA%5BConditionSearch%5D(Native-american%20Health)%20AND%20AREA%5BLastUpdatePostDate%5D%20RANGE%5B2020-08-27,MAX%5D&rank=9

Study Details | Qoyangnuptu: Peer Mentor A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, ...

5. sccvo.org sccvo.org/projects/qoyangnuptu-smart-connected-and-culturally-centered-system-support-well-being-hopitewa

Smart, Connected, and Culturally-centered System to ... Qoyangnuptu: Smart, Connected, and Culturally-centered System to Support the Well-being of Hopi/Tewa Youth · Performance Period. October 2022 - September 2026.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9505389/

Potential and Pitfalls of Mobile Mental Health Apps in ... The majority of results supported the key potential of apps in helping to (1) provide timely support, (2) ease the costs of mental healthcare, (3) combat ...

7. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLViooSi3LzC8tVtJR8nMOMTAxNjMyNDdT0tG1hAEcTDM9MwNjE0MTUx1Dc2NjA0NDIwMQ0FHKSy4xMDY3sjAzN1aKBQCOBRZ4

Save Selected ... health app, the Qoyangnuptu Intervention App (QI App) a Southwestern Tribal Community. The main questions it aims to answer are: In American Indian/Alaska ...