Development of a Mobile System for Self-management of Schizophrenia (SOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change in Social Functioning
研究概览
简要总结
This 2-arm clinical trial piloted a mobile Self-Management of Schizophrenia (SOS) system that administers interventions targeting persistent symptoms of psychosis, social dysfunction, and medication adherence. Researchers compared an intervention arm using the SOS system and an arm receiving treatment as usual on the outcomes of change in severity of psychotic symptoms and change in social functioning.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV (Diagnostic and Statistical Manual IV) criteria for schizophrenia or schizoaffective disorder based on a chart diagnosis;
- •18 years or older;
- •Prescribed oral antipsychotic medication; and
- •A rating of "3" or lower on one of the three items which comprise the Domination by Symptoms factor from the Recovery Assessment Scale, indicating patient-rated need for illness self-management
排除标准
- •Hearing, vision, or motor impairment that make it impossible to operate a smartphone or respond to prompts (determined using demonstration smartphone for screening); and
- •English reading level below 4th grade (determined using the Wide Range Achievement Test - 4th Edition)
研究组 & 干预措施
Mobile Application
Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.
干预措施: Mobile Application (Behavioral)
Treatment as Usual
Treatment as usual includes outpatient case management, linkage to services and medication monitoring.
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Change in Social Functioning
时间窗: Baseline, week 12
Social Functioning was measured using two subscales from the Social Functioning Scale (SFS): Social Engagement (5-items) and Withdrawal \& Communication (10-items). The item values range from 0 (almost never) to 3 (often). The two subscales were summed to give a score between 0-45. A higher score indicates greater social functioning.
Change in Severity of Psychotic Symptoms
时间窗: Baseline, week 12
Severity of Psychotic Symptoms was assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms.
次要结局
- Usability and Satisfaction(4 weeks)
- Change in System Use(4 weeks)