N/A
N=299
Implementing mHealth for Schizophrenia in Community Mental Health Settings
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT04147897 ↗Enrolled (actual)
299
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Patient Health Questionnaire (PHQ)-9 — 11.6; 10.7; 9.6; 10.2 Scores on scale — p=.06
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FOCUS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Health Questionnaire (PHQ)-9 |
11.6; 10.7; 9.6; 10.2; 9.3; 9.4 | .06 |
| PRIMARY Generalized Anxiety Disorder-7 (GAD-7) |
9.3; 9; 7.6; 7.9; 7.9; 7.6 | 0.37 |
| PRIMARY Insomnia Severity Index (ISI) |
12.4; 12.4; 11.4; 11.9; 12.6; 11.1 | .619 |
| PRIMARY Green Paranoid Thoughts Scale- Part B |
31.8; 32.5; 31.6; 30.4; 32.4; 30.1 | .32 |
| PRIMARY Symptom Check List (SCL-9) |
13.7; 13; 11.2; 11.7; 10.7; 11.3 | .31 |
| PRIMARY Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) |
14.3; 13.8; 13.6; 12.5; 13.0; 11.5 | .63 |
| PRIMARY Illness Management and Recovery Scales (IMRS) |
49.7; 49.8; 51.0; 50.7; 50.4; 51.2 | 0.67 |
Summary
Randomized control trial examining two mHealth intervention strategies.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04147897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.