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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a smartphone app called GUIDE to assess its impact on mental health, social connections, and personal growth among first responders, soldiers, and veterans. It will also examine the app's influence on workplace engagement and burnout. Participants will be randomly assigned to one of three groups: immediate app access with incentives, immediate access without incentives, or a waitlist with delayed access. The trial seeks law enforcement, military personnel, or veterans who own a compatible smartphone and are currently employed. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance mental health support for their community.

Will I have to stop taking my current medications?

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

What prior data suggests that the GUIDE App is safe for mental health?

Research shows that the GUIDE App is designed to enhance mental wellness and resilience, particularly for individuals in high-stress professions like first responders and soldiers. Clinical testing has confirmed its effectiveness.

In past studies, users found the app easy to use, with no serious side effects reported. This indicates that people generally feel safe and comfortable using it. The app provides mental health support without causing harm, making it a promising tool for those seeking to improve their mental well-being.

Overall, based on past research, the GUIDE App is considered safe. As a digital tool, it does not involve medication or physical procedures, making it a low-risk option for enhancing mental health and social connections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GUIDE app for mental health because it offers a fresh approach to managing mental wellness through digital means. Unlike traditional therapies like talk therapy or medication, GUIDE uses a smartphone app to deliver support and interventions, making mental health care more accessible and convenient. The app can engage users actively with or without incentives, potentially increasing motivation and adherence to mental health practices. This tech-forward approach could redefine how people interact with mental health resources, offering support anytime and anywhere.

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

Studies have shown that the GUIDE App positively impacts mental health, emotional well-being, and social connectedness. Research indicates the app significantly boosts resilience and wellness, particularly for military personnel and first responders, who often face stigma when seeking help. The app's all-in-one approach, which includes mental health, fitness, and financial planning, improves morale and productivity. By providing timely support and reducing healthcare costs, the GUIDE App helps fight stigma and encourages mental health care. These findings suggest the app could effectively enhance mental wellness for users. Participants in this trial will either receive immediate access to the GUIDE App with or without incentives or be placed on a waitlist for delayed access. ^{1 3 6 7 8}

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

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]

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 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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12579301/

Evaluating a Mobile Health Intervention (GUIDE App) for ...

Data Analysis. To test how GUIDE access impacted our primary outcomes of wellness, emotional well-being, mental health, social connectedness ...

2.

theguideapp.com

theguideapp.com/

The GUIDE App™ | Mental Wellness App For First ...

The app's focus on holistic wellness—combining mental health, fitness, and financial planning—has had a positive impact on both morale and productivity.

3.

lauraburgess.com

lauraburgess.com/the-guide-app-demonstrates-significant-resilience-and-wellness-improvements-for-military-and-first-responder-community-in-pilot-study/

The GUIDE App Demonstrates Significant Resilience and ...

Seeking help can have a stigma within these communities, with individuals fearing that they will be seen as weak or unfit for duty or service.

4.

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 stigma ...

5.

withpower.com

withpower.com/trial/phase-mental-health-wellness-3-2024-8dae3

Wellness App for Mental Health · Info for Participants

Trial Overview The GUIDE App is being tested to evaluate its effectiveness on improving mental wellness among participants. The study involves comparing three ...

6.

humanfactors.jmir.org

humanfactors.jmir.org/2025/1/e64867/

Provider Perspectives on the Use of Mental Health Apps, and ...

It is based on BRITE, a patient-facing safety planning app developed by researchers in psychiatry and psychology at the University of Pittsburgh ...

7.

emhprac.org.au

emhprac.org.au/news/assessing-the-safety-and-quality-of-digital-mental-health-apps-a-guide-for-health-practitioners/

Assessing the Safety and Quality of Digital Mental Health ...

A variety of frameworks have been developed across the globe to guide the assessment of health apps in domains considered essential for quality ...

8.

reddit.com

reddit.com/r/IAmA/comments/uo3ahw/were_the_researchers_who_looked_into_the_privacy/

We're the researchers who looked into the privacy of 32 ...

A mental health app would be a non-covered entity, so depending on the type of data collected - the data could be considered PHI. If PHI is ...