Evaluation of mHealth for Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Change in Depressive Symptoms
研究概览
简要总结
This study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •18 years or older
- •Owns an Android or iPhone smartphone with WiFi or 3G/4G capabilities (required for data transmission)
- •Has diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar Disorder or Major Depression
- •English speaker
排除标准
- •Does not live in the U.S.
- •Has already participated in the study
- •Unavailable for 60 days
- •Currently incarcerated or hospitalized
结局指标
主要结局
Change in Depressive Symptoms
时间窗: Baseline, 30 days, 60 days
The Beck Depression Inventory is a self-reported 21-item inventory, scores range from 0-63 and items are summed to compute the total score. A higher score represents more depressive symptoms.
Change in Paranoid Thinking
时间窗: Baseline, 30 days, 60 days
The Green Paranoid Thoughts Scale Parts A \& B is a 32-item scale, the total score is summed with a range of 16-80. A higher score represents more symptoms of paranoid thinking.
Change in Psychotic Symptoms
时间窗: Baseline, 30 days, 60 days
The Hamilton Program for Schizophrenia Voices Questionnaire is a 13-item questionnaire, 9 of the items are scored 0 (least severe or impairing) to 4 (most severe). The total score is intended to indicate the overall severity of psychotic symptoms. Total score range is 0-36. The remaining 4 items are intended to assess qualitative aspects.
Participant Acceptability
时间窗: 30 days
Participant Acceptability/Usability Ratings Scale is a 26-item scale measuring participant-rated acceptability of the intervention. Participants rate statements on a scale of Disagree (0), Neutral (1), or Agree (2). Items are summed to create a total score and a higher total score indicates greater acceptability.
Change in Anxiety Symptoms
时间窗: Baseline, 30 days, 60 days
The Generalized Anxiety Disorder 7-item Scale is summed with a total score range of 0-21. Higher scores represent more symptoms of anxiety.
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