Implementing mHealth for Schizophrenia in Community Mental Health Settings

Randomized control trial examining two mHealth intervention strategies.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Device: FOCUS

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 299
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Chehalis, Washington, United States, 98532
      • Cascade Mental Health Care
    • Colville, Washington, United States, 99114
      • NEW Alliance Counseling Services
    • Everett, Washington, United States, 98201
      • Compass Health
    • Federal Way, Washington, United States, 98003
      • Valley Cities
    • Port Angeles, Washington, United States, 98362
      • Peninsula Behavioral Health
    • Seattle, Washington, United States, 98125
      • Sound Health
    • Spokane, Washington, United States, 99201
      • Frontier Behavioral Health
    • Yakima, Washington, United States, 98902
      • Comprehensive Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

All participants need to be receiving clinical care at participating clinics who have partnered with the research team for this study.

Inclusion:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Internal Facilitation; mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.	Device: FOCUS; FOCUS is a self management mHealth application for people with serious mental illness.
Active Comparator: External Facilitation; mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.	Device: FOCUS; FOCUS is a self management mHealth application for people with serious mental illness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Dror Ben-Zeev, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): September 16, 2024
• Study Completion (Actual): September 16, 2024

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: STUDY00006141; 1R01MH116057-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No