Implementing mHealth for Schizophrenia in Community Mental Health Settings

Randomized control trial examining two mHealth intervention strategies.

Study Overview

• Status: Enrolling by invitation
• 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 (Anticipated): 300
• 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
• Genders Eligible for Study: All

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
Change in PhQ9	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 worsening of symptoms.	0,3,6 months
Change in GAD-7	The Generalized Anxiety Disorder-7 measures generalized anxiety disorder. GAD-7 total score ranges from 0 to 21. Higher scores represent worsening of symptoms.	0,3,6 months
Change in Insomnia Severity Index	The Insomnia Severity Index (ISI) is a brief screening assessment tool designed to evaluate insomnia.Total scores range from 0-28. Higher scores represent worsening of symptoms.	0,3,6 months
Change in Green Paranoid Thoughts Scale- ideas and persecution sub-scale	The Green Paranoid Thoughts Scale (GPTS)- sub-scale: measures ideas of persecution. Scores range from 16-80. Higher scores represent worsening of symptoms.	0,3,6 months
Change in Symptom Check List SCL9	The Symptom Check List-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 (sum of all responses) then divided by 9 for an average global score. Total sum scores range from 0-36. Average global scores range from 0-4. Higher scores mean more severe symptoms.	0,3,6 months
Change in 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
Change in Illness Management and Recovery Scale	IMRS measures illness management and recovery. Scoring is a sum of all responses ranging from 15-75. Higher scores mean more severe symptoms.	0,3,6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): April 1, 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 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic 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