Implementing mHealth for Schizophrenia in Community Mental Health Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 8
- 主要终点
- Green Paranoid Thoughts Scale- Part B
研究概览
简要总结
Randomized control trial examining two mHealth intervention strategies.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants need to be receiving clinical care at participating clinics who have partnered with the research team for this study.
- •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.
排除标准
- •Used FOCUS in the past;
- •Plan to move or discontinue services at participating clinics in the upcoming 6 months.
研究组 & 干预措施
Internal Facilitation
mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
干预措施: FOCUS (Device)
External Facilitation
mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.
干预措施: FOCUS (Device)
结局指标
主要结局
Green Paranoid Thoughts Scale- Part B
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Dror Ben-Zeev
Professor, School of Medicine: Psychiatry And Behavioral Sciences
University of Washington