Implementing mHealth for Schizophrenia in Community Mental Health Settings

NCT ID: NCT04147897

Last Updated: 2025-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-16

Study Completion Date

2024-09-16

Brief Summary

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Randomized control trial examining two mHealth intervention strategies.

Detailed Description

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The investigators will conduct a multi-site site hybrid type III effectiveness/implementation study in Washington State. The study involves a systematic head-to-head comparison between External Facilitation (EF) and Internal Facilitation (IF) implementation models applied to the FOCUS mHealth intervention.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Internal Facilitation

mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.

Group Type ACTIVE_COMPARATOR

FOCUS

Intervention Type DEVICE

FOCUS is a self management mHealth application for people with serious mental illness.

External Facilitation

mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.

Group Type ACTIVE_COMPARATOR

FOCUS

Intervention Type DEVICE

FOCUS is a self management mHealth application for people with serious mental illness.

Interventions

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FOCUS

FOCUS is a self management mHealth application for people with serious mental illness.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, schizotypal disorder, delusional disorder, or schizophreniform disorder;
2. 18 years or older;
3. English-speaking;
4. Own a smartphone that can support FOCUS and active data plan.

Exclusion:

1. Used FOCUS in the past;
2. Plan to move or discontinue services at participating clinics in the upcoming 6 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Dror Ben-Zeev

Professor, School of Medicine: Psychiatry And Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dror Ben-Zeev, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Cascade Mental Health Care

Chehalis, Washington, United States

Site Status

NEW Alliance Counseling Services

Colville, Washington, United States

Site Status

Compass Health

Everett, Washington, United States

Site Status

Valley Cities

Federal Way, Washington, United States

Site Status

Peninsula Behavioral Health

Port Angeles, Washington, United States

Site Status

Sound Health

Seattle, Washington, United States

Site Status

Frontier Behavioral Health

Spokane, Washington, United States

Site Status

Comprehensive Healthcare

Yakima, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01MH116057-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00006141

Identifier Type: -

Identifier Source: org_study_id

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