Implementing mHealth for Schizophrenia in Community Mental Health Settings
2 other identifiers
interventional
299
1 country
8
Brief Summary
Randomized control trial examining two mHealth intervention strategies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Jun 2020
Typical duration for not_applicable schizophrenia
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedStudy Start
First participant enrolled
June 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2024
CompletedResults Posted
Study results publicly available
November 24, 2025
CompletedNovember 24, 2025
November 1, 2025
4.3 years
October 14, 2019
September 8, 2025
November 10, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
Patient Health Questionnaire (PHQ)-9
The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ. Total scores range from 0-27. Higher scores represent more severe symptoms.
0,3,6 months
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) measures generalized anxiety disorder symptoms. GAD-7 total score ranges from 0 to 21. Higher scores represent more severe symptoms.
0,3,6 months
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a brief screening assessment tool designed to evaluate insomnia. Total scores range from 0-28. Higher scores represent more severe symptoms.
0,3,6 months
Green Paranoid Thoughts Scale- Part B
The Green Paranoid Thoughts Scale (GPTS)- part B measures ideas of persecution. Scores range from 16-80. Higher scores represent more severe symptoms.
0,3,6 months
Symptom Check List (SCL-9)
The Symptom Check List-9 (SCL-9) is a brief version of the SCL-90, which aims to evaluate a broad range of psychological problems and symptoms of psychopathology. Total scores are calculated as sum of all responses. Total sum scores range from 0-36. Higher scores mean more severe symptoms.
0,3,6 months
Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)
A 9-item measure specifically designed to quantify characteristics of auditory hallucinations including frequency, negative content, loudness, duration, interference with life, distress, impact on self-appraisal, and compliance with commands. Total score is a sum of all 9 items. Total HPSVQ scores range from 0-36. Higher scores mean more severe symptoms.
0,3,6 Months
Illness Management and Recovery Scales (IMRS)
The Illness Management and Recovery Scales (IMRS) measure illness management and recovery. Scoring is a sum of all responses ranging from 15-75. Higher scores mean less severe symptoms.
0,3,6 months
Study Arms (2)
Internal Facilitation
ACTIVE COMPARATORmHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
External Facilitation
ACTIVE COMPARATORmHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.
Interventions
FOCUS is a self management mHealth application for people with serious mental illness.
Eligibility Criteria
You may qualify if:
- Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, schizotypal disorder, delusional disorder, or schizophreniform disorder;
- years or older;
- English-speaking;
- Own a smartphone that can support FOCUS and active data plan.
You may not qualify if:
- Used FOCUS in the past;
- Plan to move or discontinue services at participating clinics in the upcoming 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Cascade Mental Health Care
Chehalis, Washington, 98532, United States
NEW Alliance Counseling Services
Colville, Washington, 99114, United States
Compass Health
Everett, Washington, 98201, United States
Valley Cities
Federal Way, Washington, 98003, United States
Peninsula Behavioral Health
Port Angeles, Washington, 98362, United States
Sound Health
Seattle, Washington, 98125, United States
Frontier Behavioral Health
Spokane, Washington, 99201, United States
Comprehensive Healthcare
Yakima, Washington, 98902, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dror Ben-Zeev, Professor
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Dror Ben-Zeev, PhD
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, School of Medicine: Psychiatry And Behavioral Sciences
Study Record Dates
First Submitted
October 14, 2019
First Posted
November 1, 2019
Study Start
June 16, 2020
Primary Completion
September 16, 2024
Study Completion
September 16, 2024
Last Updated
November 24, 2025
Results First Posted
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share