mHealth App for Psychosis

Overseen By Benjamin E Buck, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Antipsychotics

Disqualifiers: Graduated mental health program, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to assist young people at risk for psychosis. The app, called NORTH, aims to improve wellness by providing educational lessons, therapy-based practices, symptom tracking, and help-seeking resources. The study compares a "Full" version of the app, which includes all features, with a "Lite" version that excludes help-seeking resources. It suits individuals aged 18-30 living in the U.S. who have experienced symptoms of psychosis within the last five years and are not currently receiving specialized mental health treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions for young adults.

Do I have to stop taking my current medications to join the trial?

The trial requires that you have not taken a prescribed antipsychotic medication in the past three months. If you are currently taking such medication, you would not be eligible to participate.

What prior data suggests that this mHealth app is safe for young people at risk for psychosis?

Research has shown that mobile health apps, like the NORTH app, are generally safe for users. Studies have found that many people feel comfortable using these apps as part of their healthcare, provided their data remains secure and private. However, specific safety information for the NORTH app is not yet available. This trial is in an early stage and primarily examines user interaction and ease of use. Reports of serious side effects from using mobile health apps for mental health are absent, suggesting they are well-tolerated. A clearer picture of safety will emerge as more people try the app and share their experiences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth app, NORTH, for psychosis because it offers a new digital approach to support young adults at risk. Unlike traditional treatments that often rely on medication or face-to-face therapy, NORTH provides a convenient and accessible smartphone application. This app not only empowers users by giving them tools to manage their mental health anywhere, anytime, but it also connects them with the research team for technical support, ensuring they are never alone in their journey. The "Lite" and "Full" versions of the app allow for tailored experiences, potentially enhancing engagement and effectiveness.

What evidence suggests that this mHealth app is effective for psychosis?

Research shows that mobile health apps can help manage early signs of psychosis. This trial will compare two versions of the NORTH app: the "Lite" version and the "Full" version. These apps offer tools for self-care, symptom tracking, and stress management. Studies have found that such apps encourage people to seek help, which is crucial for reducing untreated psychosis. Specifically, apps with features like educational content and practices based on Cognitive-Behavioral Therapy have proven effective. The NORTH app also includes resources for finding help, which can increase user involvement in treatment. Overall, mobile health apps have shown promise in supporting young people at risk for psychosis. ^{1 2 3 5 6}

Who Is on the Research Team?

Benjamin Buck, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-30 in the U.S. who are at risk for psychosis but haven't been treated with antipsychotic meds or regular psychotherapy recently. They must own an iPhone and be within five years of their first psychotic episode or symptom onset.

Inclusion Criteria

I haven't taken antipsychotic medication or attended multiple psychotherapy sessions in the last 3 months.

I own an iPhone.

Elevated risk for psychosis that warrants further evaluation (a distress score >= 20 on the Prodromal Questionnaire, Brief [PQ-B], per Savill et al., 2018; and a positive frequency average score >= 1.47 on the Community Assessment of Psychic Experiences [CAPE-P15], per Jaya et al., 2021 and Bukenaite et al., 2017) and confirmation of symptoms consistent with online data collection checks (per Moritz et al., 2013)

Exclusion Criteria

Failed to demonstrate understanding of study details in comprehension screening process

I have been in mental health treatment recently, either through medication or therapy.

Unengaged in treatment, but only as a result of having completed or 'graduated' from a specialty mental health program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the NORTH or NORTH 'Lite' mobile health intervention, including psychoeducational lessons, CBT-based practices, and symptom tracking

12 weeks

Remote engagement with the app

Follow-up

Participants are monitored for changes in treatment-seeking attitudes, resilience, internalized stigma, and perceived stress

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NORTH

Trial Overview The study tests a mobile health intervention, NORTH, designed to help those at risk for psychosis. It compares the full version (with lessons, practices, tracking, and help-seeking resources) against a 'Lite' version that lacks help-seeking features.

How Is the Trial Designed?

Group I: NORTH "Lite" Experimental Treatment 1 Intervention

Participants in the control arm will be provided access to the NORTH "Lite" smartphone application designed to support young adults at risk for psychosis. They will also have access to the research team by phone for technical troubleshooting and support as necessary.

Group II: NORTH "Full" Experimental Treatment 1 Intervention

Participants in the experimental arm will be provided access to the "Full" NORTH smartphone application designed to support young adults at risk for psychosis. They will also have access to the research team by phone for technical troubleshooting and support as necessary.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A study involving 80 individuals at clinical high risk for psychosis showed that using a mobile app for cognitive training significantly improved attention and vigilance over three months compared to a control group.

The improvement in cognitive function was linked to the amount of time spent on training, indicating that mobile health applications can effectively enhance cognitive abilities in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing attention and memory of individuals at clinical high risk for psychosis with mHealth technology. Li, H., Yang, S., Chi, H., et al.[2021]

The smartphone application 'Heal Your Mind' (HYM) was developed for cognitive-behavioral case management in young individuals with early psychosis, featuring modules for symptom and thought recording, which facilitates real-time feedback from case managers.

In a pilot survey of 24 clients, over 80% found the app easy to use and reported satisfaction, with 70% indicating that it helped them, suggesting its potential as a beneficial tool in managing early psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and feasibility of smartphone application for cognitive-behavioural case management of individuals with early psychosis. Kim, SW., Lee, GY., Yu, HY., et al.[2019]

A study involving 342 individuals with schizophrenia-spectrum disorders showed that they can actively engage with a mobile phone intervention (FOCUS) for up to 6 months after hospital discharge, with an average engagement of 82% of the weeks.

Demographic factors such as gender, race, and age influenced engagement levels, with females and white participants using the intervention more frequently, indicating that tailored approaches may enhance mHealth program effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth for Schizophrenia: Patient Engagement With a Mobile Phone Intervention Following Hospital Discharge. Ben-Zeev, D., Scherer, EA., Gottlieb, JD., et al.[2020]

Integrating a smartphone app for symptom tracking in the University of California, Davis Early Psychosis Program was found to be feasible for adolescents and young adults, with participants using the app for up to 14 months.

Self-reported symptom data collected through the app was comparable to traditional clinician-rated assessments, suggesting that mobile health technology can effectively support early psychosis outpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing early psychosis treatment using smartphone technology: A longitudinal feasibility and validity study. Niendam, TA., Tully, LM., Iosif, AM., et al.[2019]

A study involving 104 young adults with first episode psychosis and cannabis use disorder revealed a strong preference for moderate intensity interventions (15-minute modules) and weekly feedback on cannabis use, highlighting the importance of patient engagement in treatment.

The findings guided the development of iCanChange (iCC), a smartphone app designed to provide tailored interventions for cannabis use disorder, which is currently undergoing clinical testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating preferences for online psychological interventions to decrease cannabis use in young adults with psychosis: An observational study. Tatar, O., Abdel-Baki, A., Dyachenko, A., et al.[2023]

This feasibility trial will assess the effectiveness of a self-management Smartphone app called My Journey 3 in supporting adults in Early Intervention in Psychosis (EIP) services, involving 40 participants over a 12-month period.

The study aims to evaluate not only the feasibility of a larger trial but also key outcomes such as relapse rates, mental health, recovery, and quality of life, providing insights into the potential benefits of digital interventions in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App to support Recovery in Early Intervention Services (ARIES) study: protocol of a feasibility randomised controlled trial of a self-management Smartphone application for psychosis. Steare, T., O'Hanlon, P., Eskinazi, M., et al.[2020]

Mobile Health interventions (m-Health) for patients with psychosis are feasible and user-friendly, showing promise in improving treatment adherence and reducing hospital admissions.

These interventions effectively monitor the evolution of psychotic symptoms, although the lack of standardized methodologies across studies makes it challenging to determine which specific strategies are most effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of mobile technologies in patients with psychosis: A systematic review. Bonet, L., Izquierdo, C., Escartí, MJ., et al.[2018]

A review of schizophrenia apps revealed that while there are many research apps (60 identified), only a small number (9) are easily accessible to patients, indicating a gap between research and public availability.

Most marketplace apps (537 found) primarily offer psychoeducation and lack regular updates, with an average of 1121 days since the last update, highlighting the need for more clinically relevant and sustainable app interventions for schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accessibility and availability of smartphone apps for schizophrenia. Kwon, S., Firth, J., Joshi, D., et al.[2022]

A study involving 77 young adults with early psychosis found that there is a high interest in mobile health (mHealth) interventions, particularly for information on medications, managing stress, and tracking symptoms, indicating a strong potential for these tools to engage this population.

Participants preferred straightforward delivery methods, such as text communication and direct interaction with healthcare providers, suggesting that mHealth strategies should focus on clear psychoeducational content to effectively support young adults with early psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth for Young Adults with Early Psychosis: User Preferences and Their Relationship to Attitudes About Treatment-Seeking. Buck, B., Chander, A., Tauscher, J., et al.[2022]

The Mobile After-Care Support (MACS) intervention, designed for patients transitioning from inpatient to outpatient care for schizophrenia-spectrum disorders, was found to be feasible and acceptable, with positive usability and satisfaction ratings from participants.

After using MACS for one month, participants showed significant reductions in dysfunctional coping strategies and psychiatric symptoms, indicating that this mobile health intervention could effectively support patients during a critical transition period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Initial Testing of an mHealth Transitions of Care Intervention for Adults with Schizophrenia-Spectrum Disorders Immediately Following a Psychiatric Hospitalization. Moitra, E., Park, HS., Gaudiano, BA.[2022]

Citations

1. psychiatry.uw.edu psychiatry.uw.edu/project/north-developing-a-mobile-health-intervention-to-support-treatment-seeking-in-early-psychosis/

NORTH: Developing a mobile health intervention to ... NORTH: Developing a mobile health intervention to support treatment seeking in early psychosis. Project Type(s): Clinical Research. Principal Investigator(s):.

2. withpower.com withpower.com/trial/phase-psychotic-disorders-5-2023-c13f3

mHealth App for Psychosis · Info for Participants It helps with self-management, encourages help-seeking, and provides information on medications, stress management, and symptom tracking.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10291100/

Mobile health in the specific management of first-episode ... The purpose of this systematic literature review is to assess the therapeutic efficacy of mobile health methods in the management of patients ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11704647/

Characteristics and Outcomes of mHealth Interventions in ... This study aimed to critically review outcome measures used to evaluate mHealth interventions for adults with psychosis in relation to the characteristics of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S092099642400389X

Hybrid mHealth care: Patient perspectives of blended ... A 2019 meta-analysis identified 66 randomised controlled trials of app-supported smartphone interventions for mental health problems.

6. jmir.org jmir.org/2025/1/e71989

Smartphone-Based Self-Monitoring in First Episode ... Most participants supported the idea of using an app as part of their clinical care, provided data security and privacy were adequately ...