Mobile Health Apps for Mental Health

(COMPASS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Eating disorder, Cognitive restrictions, Pediatric appointment

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mobile health interventions can assist individuals while they wait for in-person mental health care. Participants will use an app offering either Cognitive Behavioral Therapy (CBT) or Mindfulness exercises, with some receiving customized messages to assess their impact. The goal is to determine if these app-based treatments can enhance mental health. Individuals seeking mental health services at specific Michigan clinics and who have daily access to a compatible smartphone may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mobile apps for Cognitive Behavioral Therapy (CBT) are generally easy to use. One study examined apps like Mind Booster Green, which included engaging activities and personalized content, and found that these apps can help reduce symptoms of depression. Another study focused on the "Psicovida" app, which uses CBT to support healthcare workers. Users reported a positive experience with it and did not report any major side effects.

For Mindfulness apps, studies also suggest they are safe and easy to use. Research on various mindfulness apps found they can effectively reduce stress and improve mental health. Users found these apps helpful, with no significant negative effects.

Overall, both CBT and Mindfulness apps appear safe for users. They provide a way to support mental health without serious risks, according to the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mobile health apps for mental health because they offer a new way to deliver Cognitive Behavioral Therapy (CBT) and Mindfulness practices. Unlike traditional face-to-face therapy, these apps allow users to access treatment anytime and anywhere, which can make mental health support more accessible and convenient. Additionally, the inclusion of tailored messages and activity trackers can personalize the experience, potentially increasing engagement and effectiveness. This innovative approach could complement existing therapies like in-person counseling and medication, providing a flexible option for those seeking mental health support.

What evidence suggests that this trial's treatments could be effective for mental health?

This trial will compare different mobile health app interventions for mental health. Participants may receive Cognitive Behavioral Therapy (CBT) with or without tailored messages, or Mindfulness with or without tailored messages. Studies have shown that CBT, whether online or in person, effectively reduces anxiety and depression symptoms. App-based CBT programs have successfully engaged users, especially when personalized messages are included, enhancing treatment effectiveness. Research also shows that mindfulness apps help reduce depression and anxiety symptoms, with personalized messages possibly enhancing these benefits. Mindfulness-based approaches have improved mental health issues like stress and depression. Both CBT and mindfulness therapies offer promising options for managing mental health symptoms through mobile health tools. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals seeking mental health services from specific Michigan clinics, who have daily access to a compatible smartphone and understand English. It's not for those with current eating disorders or cognitive restrictions that prevent informed consent, nor for pediatric appointments even if the patient is 18+.

Inclusion Criteria

Seeking mental health services from Michigan Medicine, University Health Services, or collaborative clinics and services

Must have daily access to a smartphone version that is compatible with study activity trackers

Understands English to enable consent and use of the MyDataHelps app and app-based interventions

Exclusion Criteria

Self-reported or medical record indication of a current eating disorder

I am able to understand and agree to the study on my own.

My mental health appointment is for pediatric care, even though I am 18 or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mobile health interventions, including app-based Cognitive Behavioral Therapy (CBT) or Mindfulness, with or without tailored messages, and activity tracking

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy (CBT) + Tailored Messages
• Cognitive Behavioral Therapy (CBT) without Tailored Messages
• Mindfulness + Tailored Messages
• Mindfulness without Tailored Messages

Trial Overview The study tests mobile health interventions in patients awaiting in-clinic mental health treatment. It compares mindfulness and Cognitive Behavioral Therapy (CBT), both with and without tailored messages, to see which approach benefits patients more.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy (CBT) with tailored messages Active Control 1 Intervention

Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.

Group II: Mindfulness with tailored messages Active Control 1 Intervention

Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.

Group III: Mindfulness without tailored messages Active Control 1 Intervention

Participants will receive an app-based intervention and standard feedback from activity tracker.

Group IV: Cognitive Behavioral Therapy (CBT) without tailored messages Active Control 1 Intervention

Participants will receive an app-based intervention and standard feedback from activity tracker.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A study involving 70 college students showed that using a conversational agent (Woebot) for 2 weeks significantly reduced symptoms of depression compared to an information-only control group, indicating its efficacy in delivering cognitive-behavioral therapy (CBT).

Participants engaged with the Woebot an average of 12 times, demonstrating good feasibility and acceptability, with feedback suggesting that the interaction process was more important to users than the content itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. Fitzpatrick, KK., Darcy, A., Vierhile, M.[2020]

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]

The study involved 68 participants who received individually tailored text messages alongside telephone-based psychotherapy, but there were no significant differences in clinical outcomes compared to a historical control group of 157 participants who only received psychotherapy.

While both groups showed improvement over time, the SMS intervention did not enhance clinical outcomes, and the study suggests that further research with a larger sample size is needed to better assess the potential benefits of text messaging in psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison between phone-based psychotherapy with and without text messaging support in between sessions for crisis patients. Furber, G., Jones, GM., Healey, D., et al.[2021]

A digital mental health program providing internet-based cognitive behavioral therapy (iCBT) was successfully implemented in primary care, with 2,228 patients prescribed the program and nearly 49% enrolling, indicating good acceptance among patients.

Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in anxiety scores (GAD-7), demonstrating the efficacy of digital tools in treating mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

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]

An automated text-messaging system was developed to support cognitive-behavioral therapy (CBT) for depression, focusing on enhancing homework adherence and tracking patient progress among low-income patients.

In a feasibility test with 12 participants in two CBT groups, the system achieved a 65% response rate to daily mood inquiries and received positive feedback, suggesting it could be a cost-effective tool to improve mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Messaging as an Adjunct to CBT in Low-Income Populations: A Usability and Feasibility Pilot Study. Aguilera, A., Muñoz, RF.[2022]

Standalone smartphone-based ecological momentary interventions (EMIs) based on cognitive behavioral therapy (CBT) principles have been shown to significantly improve well-being and reduce mental health symptoms among users, according to a review of 26 studies.

Users rated these EMIs as helpful and satisfying, indicating their potential as scalable and accessible mental health support, especially important during global crises like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone Smartphone Cognitive Behavioral Therapy-Based Ecological Momentary Interventions to Increase Mental Health: Narrative Review. Marciniak, MA., Shanahan, L., Rohde, J., et al.[2020]

When cognitive behavioral therapy (CBT) is conducted effectively, the rate of adverse events is very low, comparable to or even lower than that of a placebo, indicating its safety and efficacy.

Many adverse events arise from poor-quality CBT due to therapists' insufficient training, highlighting the importance of regular patient assessments and supervision to ensure high standards in therapy delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. Okmaoto, Y., Jinnin, R., Yoshino, A., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943665/

Next-Generation Cognitive-Behavioral Therapy for Depression Teletherapy-based CBT is hypothesized to demonstrate similar, if not superior, efficacy outcomes to in-person therapy. Teletherapy provides flexibility, reduces ...

2. mhealth.jmir.org mhealth.jmir.org/2025/1/e50006

App-Based CBT for College Students: Randomized Trial Tailored mental health intervention programs have been generally reported to positively affect user adherence, thereby enhancing program ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214782925000557

Internet-based CBT for Anxiety/Depression in Brazilians This study examines the efficacy of individually tailored ICBT intervention with on-demand support for reducing anxiety and depressive symptoms in young adults.

4. frontiersin.org frontiersin.org/journals/global-womens-health/articles/10.3389/fgwh.2023.1182267/full

The effectiveness of CBT-based daily supportive text ... Results: The results from the longitudinal study indicated a significant reduction in anxiety prevalence and anxiety symptoms, with a 19.63% decrease in GAD-7 ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2805591

A Precision Treatment Model for Internet-Delivered ... Self-guided i-CBT is sometimes equally or more effective than guided i-CBT for depression but not anxiety.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7691088/

Standalone Smartphone Cognitive Behavioral Therapy ... This review investigates standalone smartphone-based ecological momentary interventions (EMIs) built on principles derived from CBT that aim to improve mental ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06840457

Study Details | NCT06840457 | COMPASS: a ... Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker. Intervention/Treatment, Behavioral ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/15228835.2025.2491347?af=R

Personalized Mobile Apps for Mental Health and Well ... Common psychological support interventions utilized in MHapps have included components from Cognitive Behavioral Therapy (CBT), Acceptance and commitment ...

9. sciencedirect.com sciencedirect.com/org/science/article/pii/S2292949525001683

Mobile-Based Cognitive Behavioral Therapy for Health ... This study aims to evaluate the effectiveness of Psicovida, a mobile app that delivers CBT-based interventions, in reducing depressive symptoms and emotional ...