Implementing mHealth for Schizophrenia in Community Mental Health Settings

Study Overview
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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.

Official Title
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Implementing mHealth for Schizophrenia in Community Mental Health Settings

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: FOCUS


Participation Criteria
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Eligibility Criteria
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All participants need to be receiving clinical care at participating clinics who have partnered with the research team for this study. Inclusion: Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, schizotypal disorder, delusional disorder, or schizophreniform disorder; 18 years or older; English-speaking; Own a smartphone that can support FOCUS and active data plan. Exclusion: Used FOCUS in the past; Plan to move or discontinue services at participating clinics in the upcoming 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |