Implementing mHealth for Schizophrenia in Community Mental Health Settings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 299
- Locations
- 16
- Primary Endpoint
- Green Paranoid Thoughts Scale- Part B
Study Overview
Brief Summary
Randomized control trial examining two mHealth intervention strategies.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Green Paranoid Thoughts Scale- Part B
Time Frame: 0,3,6 months
The Green Paranoid Thoughts Scale (GPTS)- part B measures ideas of persecution. Scores range from 16-80. Higher scores represent more severe symptoms.
Patient Health Questionnaire (PHQ)-9
Time Frame: 0,3,6 months
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.
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 0,3,6 months
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.
Insomnia Severity Index (ISI)
Time Frame: 0,3,6 months
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.
Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)
Time Frame: 0,3,6 Months
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.
Symptom Check List (SCL-9)
Time Frame: 0,3,6 months
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.
Illness Management and Recovery Scales (IMRS)
Time Frame: 0,3,6 months
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dror Ben-Zeev
Professor, School of Medicine: Psychiatry And Behavioral Sciences
University of Washington