mHealth for Psychosis Help-seeking

NCT05905601 | Completed Results

• 2 other identifiers: STUDY00009039K23MH122504-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Early psychosis; Psychosis risk; Duration of untreated psychosis

Outcome Measures

Primary Outcomes (6)

• Change in Treatment Seeking Steps

  Treatment seeking will be measured using the Measure to Assess Steps to Service (MASS). The MASS is a 17-item self-report assessment of steps taken towards the attainment of mental health treatment, including research, social support, and engagement with service provider steps. Each item is endorsed on a three-point Likert scale (0 = No, I have not done this, 1 = I have done this once or twice, 2 = I have done this multiple times). The MASS is scored by summing individual items with higher scores indicating greater levels of treatment-seeking actions (range from 0 to 34). Increases in MASS scores were intended as an outcome of the proposed study (i.e. encouraging help-seeking).

  Baseline, 6 weeks, 12 weeks

• Change in Treatment-related Attitudes/Beliefs (Treatment Beliefs)

  Help-Seeking Attitudes and Stigma will be measured primarily using the Endorsed and Anticipated Stigma Inventory (EASI). The full EASI is a 40-item self-reported questionnaire with subscales measuring beliefs about mental illness, beliefs about mental health treatment, beliefs about mental health treatment seeking, concerns about stigma from loved ones, and concerns about stigma from the workplace. The subscales are scored by summing the ratings from the eight individual items in each subscale (5-point scale with 1 = Strongly disagree, 5 = Strongly agree), with lower scores indicating less stigma, and more positive attitudes towards treatment and treatment-seeking. The Beliefs About Treatment Scale assesses individuals' beliefs about the efficacy and usefulness of mental health treatments. It is totaled as a sum, and thus scores range from 8 to 40 with higher scores indicating more stigmatizing attitudes toward treatment.

  Baseline, 6 weeks, 12 weeks

• Change in Treatment-related Attitudes/Beliefs (Treatment Seeking Attitudes)

  Help-Seeking Attitudes and Stigma will be measured primarily using the Endorsed and Anticipated Stigma Inventory (EASI). The full EASI is a 40-item self-reported questionnaire with subscales measuring beliefs about mental illness, beliefs about mental health treatment, beliefs about mental health treatment seeking, concerns about stigma from loved ones, and concerns about stigma from the workplace. The subscales are scored by summing the ratings from the eight individual items in each subscale (5-point scale with 1 = Strongly disagree, 5 = Strongly agree), with lower scores indicating less stigma, and more positive attitudes towards treatment and treatment-seeking. The Beliefs About Treatment Seeking assesses individuals' attitudes toward seeking mental health treatments. It is totaled as a sum, and thus scores range from 8 to 40 with higher scores indicating more stigmatizing attitudes toward treatment seeking.

  Baseline, 6 weeks, 12 weeks

• Change in Internalized Stigma

  The Internalized Stigma of Mental Health Inventory, Brief (ISMI-9) will provide additional insight into the strength of participants' internalized stigma of mental illness. The ISMI-9 is a nine-item self-report short form, where each item is rated on a four-point Likert scale (1 = Strongly disagree, 4 = Strongly agree), and totaled as a mean score. Thus scores range from 1 to 4 with higher scores indicating more severe internalization of mental illness stigma.

  Baseline, 6 weeks, 12 weeks

• Change in Perceived Stress**

  Perceived stress will be measured using the Perceived Stress Questionnaire (PSQ), which is a 30-item, self-report questionnaire that examines the experience of stress independent of a specific and objective occasion. Items are endorsed on a four-point scale (1 = Almost never, 4 = Usually), and are summed for a total score (ranging from 30 to 120), with higher scores indicating higher levels of perceived stress. \*\*NOTE: At baseline, the version provided to participants included the version of the PSQ that instructing participants to report on the past "year or two" while 6-week and 12-week assessments ask participants to report on the previous "month or so." While totals are still reported (as these still provide some information about intervention effects) these numbers should be interpreted with caution and in concert with other collected measures that include items about stress levels and coping with consistent reporting periods at all time points.

  Baseline, 6 weeks, 12 weeks

• Change in Resilience / Coping

  The Brief Resilience Scale (BRS) will be used to assess resiliency. The BRS is a self-report form that consists of six resiliency statements that participants agree or disagree with on a five-point scale (1 = Strongly disagree, 5 = Strongly agree). Scores are totaled as a mean, and thus range from 1 to 5, with higher scores indicating greater resilience.

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (6)

• Change in Symptoms (Positive)

  Baseline, 6 weeks, 12 weeks

• Change in Symptoms (Negative)

  Baseline, 6 weeks, 12 weeks

• Change in Symptoms (Depressive)

  Baseline, 6 weeks, 12 weeks

• Change in Recovery

  Baseline, 6 weeks, 12 weeks

• Change in Functioning

  Baseline, 6 weeks, 12 weeks

Study Arms (2)

NORTH "Full"

EXPERIMENTAL

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.

Behavioral: NORTH "Full"

NORTH "Lite"

EXPERIMENTAL

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.

Behavioral: NORTH "Lite"

Interventions

NORTH "Full" 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 "Full"

NORTH "Lite" 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.

NORTH "Lite"

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Benjamin Buck, Ph.D.
• Organization: University of Washington / University of North Carolina at Chapel Hill

ben.buck@med.unc.edu

(919) 445-4330

Study Officials

• Benjamin Buck, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 15, 2023
• Study Start: June 15, 2023
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Locations

US (1)