NCT04907903Unknown不适用
RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to Coronavirus-19: Study Protocol of a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 主要终点
- Outcome Questionnaire (OQ-45)
研究概览
简要总结
This study aims is the evaluation of the efficacy and feasibility of RinasciMENTE, the Randomized Controlled Clinical Trial compared with a waiting list control group.
详细描述
A sample of 128 participants, who experience psychological discomfort due to COVID-19, will be recruited. After initial screening, participants will be randomly assigned to either an experimental group or a waiting list group. Measures will be taken at the baseline (T0), at the end of the treatment (T1) and 12 months follow-up (T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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 old or over and both gender
- •Italian mother-tongue
- •Score 14 or less on Patients Health Questionnaire-9 (PHQ-9)
- •Internet access and basic informatic ability to navigate the internet platform
- •Must be able to complete a phone interview
排除标准
- •Having severe and mental impairments, psychiatric condition and neurological disorder
- •Not be able to use a computer or do not have internet access
- •Not be able to complete a phone interview
- •Score 15 or more on PHQ-9
结局指标
主要结局
Outcome Questionnaire (OQ-45)
时间窗: Baseline, 2 months follow-up, 12 months follow-up
It measures the changes in adult patients thanks to intervention.
次要结局
- World Health Organization Quality of Life (WHOQOL)-BREF(Baseline, 2 months follow-up, 12 months follow-up)
- Depression Anxiety Stress Scales-Short Version (DASS-21)(Baseline, 2 months follow-up, 12 months follow-up)
- General Self-efficacy Scale (GSES)(Baseline, 2 months follow-up, 12 months follow-up)
- Perceived stress scale (PSS)(Baseline, 2 months follow-up, 12 months follow-up)
- Emotional regulation questionnaire (ERQ)(Baseline, 2 months follow-up, 12 months follow-up)
- Fear of COVID-19 Scale (FCV-19S)(Baseline, 2 months follow-up, 12 months follow-up)
研究者
Vanessa Bertuzzi
PhD Student
Catholic University of the Sacred Heart
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