60 Participants Needed

mHealth App for Psychosis

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Overseen ByBenjamin E Buck, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The proposed study research project aims to develop and test a mobile health intervention designed to improve the wellness of young people at risk for psychosis and facilitate users' engagement with treatment and thus reduce duration of untreated psychosis. This clinical trial will involve a remote pilot randomized controlled trial that will examine (1) the feasibility of the proposed research approach, (2) the acceptability and usability of the NORTH intervention as well as (3) the specific additive value of help-seeking support in the context of self-guided mHealth for early psychosis. The full intervention, which includes psychoeducational lessons, Cognitive-Behavior Therapy-based practices, a symptom tracking feature, and help-seeking resources will be compared to a "Lite" version that will include the lessons, practices, and tracking but exclude the help-seeking resources.

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 data supports the idea that mHealth App for Psychosis (also known as: NORTH) is an effective treatment?

The available research shows that using smartphone apps for psychosis treatment is promising. One study found that integrating a smartphone app into early psychosis care is feasible and provides symptom data similar to traditional clinician assessments. Another study highlighted the potential benefits of a smartphone app for managing early psychosis, suggesting it could be a useful tool. Additionally, a study on a similar app for schizophrenia-spectrum disorders showed significant reductions in psychiatric symptoms and improved coping strategies over a month. These findings suggest that mHealth apps can be effective in managing psychosis symptoms and supporting recovery.12345

What safety data exists for the mHealth app for psychosis?

The research indicates that mHealth interventions for psychosis, including those using mobile phones, are generally feasible, acceptable, and clinically promising. However, specific safety data for the mHealth app for psychosis, potentially evaluated under the name NORTH, is not directly mentioned in the provided studies. The studies focus on the accessibility, usability, and engagement of mHealth apps for psychosis, but do not provide detailed safety data. Further research or specific clinical trials would be needed to assess the safety of this particular app.36789

Is the treatment NORTH a promising treatment for psychosis?

Yes, the mHealth app for psychosis, which includes the treatment NORTH, is promising because it offers accessible, low-cost support through smartphones. It helps with self-management, encourages help-seeking, and provides information on medications, stress management, and symptom tracking. This makes it appealing to young adults with early psychosis and can improve recovery and treatment outcomes.348910

Research Team

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Benjamin Buck, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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)
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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.

Treatment Details

Interventions

  • NORTH
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: NORTH "Lite"Experimental Treatment1 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: NORTHExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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.
Enhancing early psychosis treatment using smartphone technology: A longitudinal feasibility and validity study.Niendam, TA., Tully, LM., Iosif, AM., et al.[2019]
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.
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 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.
Accessibility and availability of smartphone apps for schizophrenia.Kwon, S., Firth, J., Joshi, D., et al.[2022]

References

Enhancing early psychosis treatment using smartphone technology: A longitudinal feasibility and validity study. [2019]
Development and feasibility of smartphone application for cognitive-behavioural case management of individuals with early psychosis. [2019]
Accessibility and availability of smartphone apps for schizophrenia. [2022]
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. [2020]
Development and Initial Testing of an mHealth Transitions of Care Intervention for Adults with Schizophrenia-Spectrum Disorders Immediately Following a Psychiatric Hospitalization. [2022]
mHealth for Schizophrenia: Patient Engagement With a Mobile Phone Intervention Following Hospital Discharge. [2020]
Evaluating preferences for online psychological interventions to decrease cannabis use in young adults with psychosis: An observational study. [2023]
mHealth for Young Adults with Early Psychosis: User Preferences and Their Relationship to Attitudes About Treatment-Seeking. [2022]
Use of mobile technologies in patients with psychosis: A systematic review. [2018]
Enhancing attention and memory of individuals at clinical high risk for psychosis with mHealth technology. [2021]