Study Protocol for a Pilot Randomized Controlled Trial on a Smartphone Application-based Intervention for Subthreshold Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
研究概览
简要总结
The investigators plan to conduct a randomized controlled trial to examine whether a Smartphone-based Intervention improves subthreshold depression symptoms compared to no intervention.
The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.
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
- •18 Years and older
- •Males and females
- •Center for Epidemiologic Studies Depression Scale score ≥16
- •Written informed consent prior to participation
- •Owns a smartphone with the iOS® operating system
排除标准
- •Lifetime history of psychiatric disorders
- •Currently receiving treatment for a mental health problem from a mental health professional
- •Experience of a major depressive episode in the 2 weeks prior to the study, as ascertained using the Mini-International Neuropsychiatric Interview
- •Vision or hearing deficits that negatively impact everyday life
结局指标
主要结局
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
时间窗: Change from Baseline CES-D at 5 weeks
The CES-D is a 20-item self-report questionnaire used to measure depressive symptoms. The CES-D is a four-point Likert scale, with each item scored from 0 to 3. The total score ranges from 0 to 60 points. The higher the score, the stronger the depressive symptoms.
次要结局
- Psychological distress as measured by the Kessler Screening Scale for Psychological Distress (K6) score.(Change from Baseline K6 at 5 weeks)
- Anxiety as measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7).(Change from Baseline GAD-7 at 5 weeks)
研究者
Kazuki Hirao, PhD, OT
Assistant Professor
Kibi International University