mHealth for Psychosis Help-seeking

NCT ID: NCT05905601

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-07-03

Brief Summary

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.

Conditions

Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NORTH "Full"

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.

Group Type: EXPERIMENTAL

NORTH "Full"

Intervention Type: BEHAVIORAL

NORTH is a native mobile app that provides on-demand content to young adults at risk for psychosis to improve or maintain their well-being, coping skills, and healthy habits, knowledge of psychosis, and provide help-seeking resources.

NORTH "Lite"

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 Type: EXPERIMENTAL

NORTH "Lite"

Intervention Type: BEHAVIORAL

NORTH "Lite" contains the same on-demand lessons, practices and tracking features found in the "Full" NORTH mobile application but does not include help-seeking resources.

Interventions

NORTH "Full"

NORTH is a native mobile app that provides on-demand content to young adults at risk for psychosis to improve or maintain their well-being, coping skills, and healthy habits, knowledge of psychosis, and provide help-seeking resources.

Intervention Type: BEHAVIORAL

NORTH "Lite"

NORTH "Lite" contains the same on-demand lessons, practices and tracking features found in the "Full" NORTH mobile application but does not include help-seeking resources.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)
• Age 18-30 years old
• Lives in the United States
• Under five years since participant's first psychotic episode or awareness of symptom onset
• Owns an iPhone
• Unengaged in specialty mental health treatment, in which the participant has not done either of the following in the previous three months: (1) taken a prescribed antipsychotic medication, (2) attended regular (i.e. more than one session of) psychotherapy.

Exclusion Criteria

• Failed to demonstrate understanding of study details in comprehension screening process.
• Engaged in specialty mental health treatment in the previous three months, defined as the following: (1) taken a prescribed antipsychotic medication, OR (2) attended regular (i.e. more than one session of) psychotherapy.
• Unengaged in treatment, but only as a result of having completed or "graduated" from a specialty mental health program.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Buck

Assistant Professor, Department of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Buck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23MH122504-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009039

Identifier Type: -

Identifier Source: org_study_id