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

4400 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Mobile Health Apps for Mental Health?

Research shows that smartphone apps based on cognitive behavioral therapy (CBT) are effective for improving mental health, as they are considered the gold standard for treating many mental health issues. Additionally, using text messages alongside CBT can help improve treatment outcomes by increasing engagement and adherence to therapy activities. ^{1 2 3 4 5}

Are mobile health apps for mental health generally safe for humans?

Mobile health apps for mental health, including those based on cognitive behavioral therapy (CBT), are generally considered safe when used appropriately. However, there are potential safety concerns related to privacy, security, and the quality of the intervention, especially if the app is not well-regulated or if the therapy is not delivered effectively. ^{1 6 7 8 9}

How does the treatment using mobile health apps for mental health differ from other treatments?

This treatment is unique because it combines Cognitive Behavioral Therapy (CBT) or Mindfulness with tailored messages delivered through mobile health apps, making mental health support more accessible and personalized. Unlike traditional therapy, it allows for real-time interventions and self-management, potentially reducing the need for in-person sessions and offering a scalable solution to mental health care. ^{1 9 10 11 12}

What is the purpose of this trial?

This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Standalone Smartphone Cognitive Behavioral Therapy-Based Ecological Momentary Interventions to Increase Mental Health: Narrative Review. [2020]

2. Canada pubmed.ncbi.nlm.nih.gov

A comparison between phone-based psychotherapy with and without text messaging support in between sessions for crisis patients. [2021]

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

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. [2021]

5. Canada 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. [2020]

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

Mobile Mental Health: Navigating New Rules and Regulations for Digital Tools. [2022]

7. 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]

8. Japan pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. [2018]

9. Canada pubmed.ncbi.nlm.nih.gov

Popular Evidence-Based Commercial Mental Health Apps: Analysis of Engagement, Functionality, Aesthetics, and Information Quality. [2021]

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Implementation of Cognitive Behavioral Therapy in e-Mental Health Apps: Literature Review. [2022]

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

Smartphone apps for psychological health: A brief state of the science review. [2019]

12. Canada pubmed.ncbi.nlm.nih.gov

The Use of Mobile Apps and SMS Messaging as Physical and Mental Health Interventions: Systematic Review. [2022]