Universal Prevention of Depression and Anxiety in the General Population Through a Personalized Intervention Based on Risk Algorithms, ICTs, and Decision Support Systems: Randomized Controlled Trial. The "PredictPlusPrevent" Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9,000
- 主要终点
- Incidence of depression and/or anxiety disorders.
研究概览
简要总结
Objective: To design, develop, and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms, ICTs, and decision support systems (DSS).
Methods: A double-blind, parallel-group, randomized controlled trial with a twelve-month follow-up. The entire process of recruitment, random allocation, intervention, and follow-up will be conducted through the 'PredictPlusPrevent' platform and its associated apps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 years without depression and/or anxiety at baseline will be randomly assigned to the intervention or active control group "PredictPlusPrevent". The "PredictPlusPrevent" intervention will be self-guided and implemented through participants' smartphones via an app; it will have a biopsychosocial and multi-component approach (8 modules: physical exercise, improving sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts). The "PredictPlusPrevent" intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans, which they will implement themselves while the platform monitors and provides feedback. The active control "PredictPlusPrevent" will include information from the risk algorithms and 24 self-help booklets. The primary outcome will be the incidence of new cases of depression and/or anxiety assessed using the PRIME-MD questionnaire, and secondary outcomes will include reductions in depression (PHQ-9) and anxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD and predictA algorithms), and physical and mental quality of life (SF-12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 55 years.
- •Participants must have a smartphone for their own use in the next year.
排除标准
- •Not signing the informed consent.
- •Having depression and/or anxiety at baseline according to the PRIME-MD questionnaire.
- •Living outside of Spain.
- •Having a severe mental disorder (psychosis, bipolar disorder, addictions, etc.), a terminal illness or cognitive impairment (dementia).
- •Difficulties in understanding Spanish.
结局指标
主要结局
Incidence of depression and/or anxiety disorders.
时间窗: 12 months
Incidence of depression and/or anxiety disorders by Primary Care Evaluation of Mental Disorders (PRIME-MD). PRIME-MD is a diagnostic tool to diagnose depression and anxiety disorders.
次要结局
- Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9).(12 months)
- Probability of anxiety measured by the Spanish predictA risk algorithm.(12 months)
- Quality of life measured by the 12-item Short Form (SF-12).(12 months)
- Probability of depression measured by the Spanish predictD risk algorithm.(12 months)
- Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7).(12 months)
研究者
Juan Ángel Bellón
Principal Investigator
The Mediterranean Institute for the Advance of Biotechnology and Health Research