Mental Health App for Well-being

Overseen By Raissa Fabregas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Graduate degree, No smartphone, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2-4 months

2100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mental health app to determine its impact on psychological well-being among Hispanic immigrants in the U.S. Participants are divided into groups to compare the effects of varying levels of app access and incentives, such as direct payments or lotteries. Suitable candidates for this trial include Hispanic immigrants who have been in the U.S. for less than 10 years, speak Spanish, and are open to using a well-being app. As an unphased trial, this study provides participants the chance to contribute to important research that could improve 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 this mental health app is safe for use?

Research has shown that mental health apps are generally safe for users. A detailed review examined the risks of using these apps and found that, while they usually work well, some users experienced negative effects, such as increased anxiety or feeling overwhelmed. However, these cases are rare, and many people benefit from the convenience and support these apps provide.

Before becoming available to the public, mental health apps often undergo thorough checks. Systems ensure they meet certain standards, reducing the likelihood of user issues. Overall, most people find these apps easy to use and helpful for improving mental well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mental Health App for Well-being because it offers a unique digital approach to enhancing mental health, which is different from traditional treatments like therapy and medication. This app gives users personalized, on-demand support, making mental health resources more accessible and potentially more engaging. The trial is exploring whether incentives, like direct payments or lottery entries, can boost user engagement, which might lead to better outcomes. By comparing different access durations and incentive types, researchers hope to discover the most effective way to encourage regular app usage and improve mental health.

What evidence suggests that this mental health app could be effective for improving psychological well-being?

Research has shown that mental health apps can help reduce symptoms of depression, anxiety, and stress. In this trial, participants will join different groups to evaluate a mental health app's effectiveness. Some participants will access the app for varying durations and may receive incentives based on their engagement. Studies have found that these apps can improve mental health, especially while waiting for traditional care. A review of multiple studies found that mental health apps are somewhat effective for conditions like depression and anxiety. Additionally, some cases have linked these apps to reduced suicidal thoughts. Overall, evidence supports that using a mental health app can improve psychological well-being. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Hispanic U.S. immigrants experiencing psychological distress. The details on specific inclusion and exclusion criteria are not provided, but typically these would outline the characteristics that participants must or must not have to join the study.

Inclusion Criteria

Do not have a graduate degree

Have a PHQ4 score that is three or more

I am over 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants have access to the well-being app for 2 to 4 months, with varying incentives based on the group assignment

2-4 months

Follow-up

Participants are monitored for psychological well-being and other outcomes after treatment

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mental Health App

Trial Overview The study tests how a mental health app affects well-being when given for either 2 or 4 months. Participants may also receive direct incentives or be entered into a lottery as part of their participation.

How Is the Trial Designed?

Group I: 4-month access and no incentive Experimental Treatment 1 Intervention

Participants have access to the well-being app for four months and receive no incentive for using the app.

Group II: 4-month access and lottery incentive Experimental Treatment 2 Interventions

Participants have access to the well-being app for four months, and participate in a lottery for gift cards if they display sufficient engagement.

Group III: 4-month access and direct incentive Experimental Treatment 2 Interventions

Participants have access to the well-being app for four months, and receive a direct payment if they display sufficient engagement.

Group IV: 2-month access and no incentive Experimental Treatment 1 Intervention

Participants have access to the well-being app for two months and receive no incentive for using the app.

Group V: 2-month access and lottery incentive Experimental Treatment 2 Interventions

Participants have access to the well-being app for two months, and participate in a lottery for gift cards if they display sufficient engagement.

Group VI: 2-month access and direct incentive Experimental Treatment 2 Interventions

Participants have access to the well-being app for two months, and receive a direct payment if they display sufficient engagement.

Group VII: control Active Control 1 Intervention

Participants do not have access to the app during the study.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

A systematic review of 52 studies on mental health apps (MHapps) found that these apps can effectively reduce mental health symptoms and improve well-being, with a small effect size for symptom reduction (Hedges g=-0.24) and a medium effect for emotion regulation (g=0.49).

Despite the promising outcomes, many studies had unclear or high risk of bias, indicating a need for more rigorous research to ensure the effectiveness and quality of MHapps, especially those targeting emotion regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apps That Promote Emotion Regulation, Positive Mental Health, and Well-being in the General Population: Systematic Review and Meta-analysis. Eisenstadt, M., Liverpool, S., Infanti, E., et al.[2023]

A new mobile health (mHealth) platform was developed to support Collaborative Care for rural patients with PTSD and bipolar disorder, integrating patient data into clinical processes, which is crucial for managing complex psychiatric conditions.

Preliminary results from the first 10 patients showed high usability of the app, with an average System Usability Scale score of 91.9, indicating that the platform is user-friendly and has potential for sustained use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the Principles for Digital Development: Case Study of a Smartphone App to Support Collaborative Care for Rural Patients With Posttraumatic Stress Disorder or Bipolar Disorder. Bauer, AM., Hodsdon, S., Bechtel, JM., et al.[2023]

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]

Mental health apps, particularly those targeting anxiety and depression, show moderate to high quality evidence of effectiveness, with small to medium effect sizes, indicating they can be beneficial for self-management or as adjunctive treatments.

While stand-alone apps demonstrated better empirical quality, studies with follow-ups indicated that the positive impacts of these apps can be sustained for at least 11 weeks, highlighting their potential for long-term support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apps for Mental Health Issues: Meta-Review of Meta-Analyses. Lecomte, T., Potvin, S., Corbière, M., et al.[2021]

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 significant 73% of psychiatrists and nurses in six Flemish psychiatric hospitals reported being involved in at least one adverse event during their careers, with suicide-related incidents being the most impactful for nearly 64% of them.

The study highlights the critical need for timely support for healthcare professionals after adverse events, as those affected are at a higher risk of experiencing further incidents within the first 4-24 hours following the event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious reportable events within the inpatient mental health care: Impact on physicians and nurses. Martens, J., Van Gerven, E., Lannoy, K., et al.[2017]

The Patients First initiative uses the CareSense platform to combine patient-reported outcomes with biological monitoring, allowing for real-time feedback on symptoms like stress, anxiety, and depression, which enhances patient engagement and care delivery.

This project is pioneering in integrating digital therapeutics and providing video resources to primary care providers, enabling them to respond effectively when patients show signs of symptom severity, marking a significant advancement in psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Psychiatric Care Through Integrated Digital Technologies. Fowler, JC., Madan, A., Bruce, CR., et al.[2023]

Mobile technology, such as smartphone apps and activity trackers, can provide real-time data on patients' symptoms and behaviors, improving the accuracy of mental health assessments compared to traditional self-reports.

Despite the potential benefits of these technologies, there are still concerns about the reliability of available apps and sensors, as well as how effectively healthcare providers can use this data in their clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile technology for mental health assessment. Areàn, PA., Hoa Ly, K., Andersson, G.[2018]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

In a study involving 1,308 patients undergoing a 2-week cognitive-behavioral therapy program, the use of touch-screen technology for daily self-report measures effectively reduced symptoms in patients at risk of poor outcomes.

The integration of touch screens in psychiatric monitoring fosters collaboration between patients and therapists, enhancing patient engagement in tracking their progress and evaluating treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving clinical outcomes in psychiatric care with touch-screen technology. Newnham, EA., Doyle, EL., Sng, AAH., et al.[2019]

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

In a study involving 301 participants with depression or anxiety, the IntelliCare platform demonstrated strong engagement, with 84% of users continuing to use the apps for a median of 92 days post-treatment.

Coaching improved anxiety outcomes significantly compared to self-guided treatment, while weekly app recommendations enhanced depression outcomes, indicating that both methods can effectively support mental health through app engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Effects of Coaching and Receipt of App Recommendations on Depression, Anxiety, and Engagement in the IntelliCare Platform: Factorial Randomized Controlled Trial. Mohr, DC., Schueller, SM., Tomasino, KN., et al.[2020]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12079407/

The evolving field of digital mental health: current evidence ... In fact, individual trials have found that, in some cases, monitoring apps may even increase the risk of depressive episodes or be associated ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0319983

Effectiveness of evidence based mental health apps on user ... This study evaluates the effectiveness of evidence-based health apps on user mental health outcomes, particularly depression, anxiety, and suicidal behaviors.

3. michiganmedicine.org michiganmedicine.org/health-lab/mental-health-apps-may-help-those-waiting-care-study-finds

Mental health apps may help those waiting for care, study finds The study shows that depression and anxiety symptoms, and suicidality, all decreased measurably when patients were assigned to mobile applications.

4. nature.com nature.com/articles/s41746-025-01567-5

A meta-analysis of persuasive design, engagement, and ... Results identified that mental health apps are moderately effective for depression, anxiety, stress, and body image/eating disorders but show ...

5. formative.jmir.org formative.jmir.org/2025/1/e68031

Improving Mental Health and Well-Being Through the ... This study aimed to explore usage patterns and preliminary outcomes related to mental health and well-being among users of an app (Paradym; Paradym Ltd)

6. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1581779/abstract

Digital Wellness or Digital Dependency? A Critical ... Strengthening regulatory oversight requires mandatory certification for mental health apps, ensuring rigorous clinical validation before market ...

7. 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 ...

8. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/articles/mental-health-apps

Mental Health Apps: What You Need to Know Wilhelm explains what mental health apps are, how to find reputable apps, and how to protect your health privacy when using any online tool.

9. nature.com nature.com/articles/s41746-024-01388-y

Systematic review and meta-analysis of adverse events in ... Mental health apps are efficacious, yet they may pose risks in some. This review (CRD42024506486) examined adverse events (AEs) from mental health apps.