Wellness App for Mental Health

Overseen By Heather J Nuske, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Not law enforcement, not employed, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

115 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the research study is to trial a smart phone application, the GUIDE App, to better understand its impact on social connectedness, personal growth and mental health/wellness among first responders, soldiers, and veterans. The research team will also investigate workplace metrics (e.g., engagement and burnout), implementation outcomes and technical merit. The investigators plan to run a three-armed randomized waitlist pilot feasibility trial with up to 150 participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Wellness App for Mental Health safe to use?

Mobile apps for mental health, like the Wellness App, can have safety concerns related to privacy, security, and potential side effects from the interventions they offer. While these apps are becoming more popular, further research is needed to fully understand their safety and any adverse effects they might have. ^{1 2 3 4 5}

How is the GUIDE treatment different from other mental health treatments?

The GUIDE treatment is unique because it is a wellness app designed to improve mental health by teaching evidence-based coping skills like relaxation, mindfulness, self-compassion, and goal-setting, making it accessible and scalable, especially during times when in-person therapy is limited. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment GUIDE in the Wellness App for Mental Health clinical trial?

Research on mental health apps shows that they can improve access to care and have positive user feedback, with many apps receiving high ratings and positive sentiments from users. However, there are challenges with app functionality and user retention that need to be addressed to enhance their effectiveness. ^{5 11 12 13 14}

Who Is on the Research Team?

Heather J Nuske, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for first responders, military personnel, and veterans interested in testing a wellness app called GUIDE. The study aims to see if the app helps with social connections, personal growth, and overall mental health. Participants will be randomly assigned to start using the app at different times.

Inclusion Criteria

Employed (part-time, full-time, self-employed)

Owns compatible smartphone

Not paid by the GUIDE App/Nlyten Corp.

Exclusion Criteria

Not law enforcement, military personnel, or veteran

Not employed

Paid by GUIDE App/Nlyten Corp

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the GUIDE App for 4 weeks to assess its impact on social connectedness, personal growth, and mental health/wellness

4 weeks

App usage monitored continuously

Follow-up

Participants are monitored for outcomes such as feasibility, appropriateness, and mental wellbeing post-trial

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GUIDE

Trial Overview The GUIDE App is being tested to evaluate its effectiveness on improving mental wellness among participants. The study involves comparing three groups: one that starts using the app immediately, another that waits before starting it, and possibly a control group without the app.

How Is the Trial Designed?

Group I: GUIDE without incentives Experimental Treatment 1 Intervention

Immediate access to the GUIDE App for 4 weeks without the opportunity to earn additional compensation.

Group II: GUIDE with incentives Experimental Treatment 1 Intervention

Immediate access to the GUIDE App smartphone application for 4 weeks with the opportunity to earn additional compensation, up to $100 in total, based on app engagement.

Group III: Waitlist Active Control 1 Intervention

Waitlisted with delayed access to the GUIDE App without the opportunity to earn additional compensation.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Nlyten Corp

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

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]

A review of 92 mental health screening and diagnostic apps revealed that while 65% of user reviews were positive, many apps suffer from high dropout rates due to issues with functionality and accessibility.

Common features like mood tracking were present in 74% of the apps, but improvements in performance and user experience are needed to enhance sustained use and effectiveness in supporting mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Solutions for Mental Health Screening and Diagnosis: A Review of App User Perspectives Using Sentiment and Thematic Analysis. Funnell, EL., Spadaro, B., Martin-Key, N., et al.[2022]

In a study involving 626 adults with mild to moderate depression, mobile apps designed for mental health showed significant benefits, particularly for those with more severe symptoms, indicating their potential effectiveness in improving mood.

Among the tested apps, the cognitive training app (Project: EVO) demonstrated the strongest impact on mood compared to a control app, suggesting that engaging cognitive processes can enhance the therapeutic effects of mobile interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial. Arean, PA., Hallgren, KA., Jordan, JT., et al.[2019]

Mobile health apps are increasingly popular for delivering healthcare services and interventions, providing benefits across various medical specialties, but they also come with potential risks that need careful consideration.

There is a critical need to study and report the safety and adverse effects of mobile apps, particularly those delivering psychosocial interventions, focusing on privacy, security, and unique digital interactions, as this is a relatively new area requiring further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update. Naeem, F., Gire, N., Xiang, S., et al.[2020]

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 'Whitu' app significantly improved emotional and mental well-being, self-compassion, and sleep, while reducing stress and depression among 90 young participants over a 4-week period, with benefits persisting at 3 months.

Participants rated the app highly for usability and acceptability, suggesting it could be an effective and scalable tool for enhancing mental health and resilience in young people, especially during challenging times like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Well-being app to support young people during the COVID-19 pandemic: randomised controlled trial. Thabrew, H., Boggiss, AL., Lim, D., et al.[2022]

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]

Citations

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

Enhancing Problem-Solving Therapy With Smartphone Technology: A Pilot Randomized Controlled Trial. [2022]

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mHealth Solutions for Mental Health Screening and Diagnosis: A Review of App User Perspectives Using Sentiment and Thematic Analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Longitudinal trends in the quality, effectiveness and attributes of highly rated smartphone health apps. [2021]

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Clinician's Guide to Evaluating and Developing eHealth Interventions for Mental Health. [2022]

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The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial. [2019]

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Actionable health app evaluation: translating expert frameworks into objective metrics. [2023]

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

Smartphone Applications for Mental Health. [2018]

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

Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update. [2020]

9. England pubmed.ncbi.nlm.nih.gov

By the numbers: ratings and utilization of behavioral health mobile applications. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot study of a well-being app to support New Zealand young people during the COVID-19 pandemic. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Yoga of Immortals Intervention Reduces Symptoms of Depression, Insomnia and Anxiety. [2021]

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E-therapies in England for stress, anxiety or depression: what is being used in the NHS? A survey of mental health services. [2022]

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

Well-being app to support young people during the COVID-19 pandemic: randomised controlled trial. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Standalone smartphone apps for mental health-a systematic review and meta-analysis. [2020]