Prevention of Depression in the Workplace Through a Personalized Intervention Based on Risk Algorithms, ICTs and Decision Support Systems: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,054
- 试验地点
- 1
- 主要终点
- Rate of major depression measured by the Composite International Diagnostic Interview (CIDI)
研究概览
简要总结
The main goal is to design, develop and evaluate a personalized intervention to prevent depression in the workplace, based on Information and Communication Technologies (ICTs), predictive risk algorithms and decision support systems (DSS) for employed workers. The specific goals are: 1) to design and develop a DSS, called e-predictD-Work-DSS to elaborate personalized plans to prevent depression and its monitoring in the employed working population; 2) to design and develop an ICT solution that integrates the DSS on the web, a mobile application (App), the predictD risk algorithm, different intervention modules (including a work stress management module) and a monitoring-feedback system; 3) to evaluate the usability, adherence, acceptability and satisfaction of employed working population with the e-pD-Work intervention; 4) to evaluate the effectiveness of the e-pD-Work intervention to reduce the incidence of major depression, depression and anxiety symptoms, the probability of major depression next year and to improve quality of life; 5) to evaluate the cost-effectiveness and cost-utility of the e-pD-Work intervention to prevent depression.
Methods: This a randomized, double-blind, controlled trial with two parallel arms (e-pD-Work vs active m-Health control) and 12 months follow-up. A total of 3,160 depression-free workers, aged between 18 and 55 years old will be recruited in Spain and randomly assigned to one of the two groups in a 1:1 ratio considering a stratification of age (18-29, 30-39, 40-49, 50-55 years) and sex similar to the Spanish population. Participants, interviewers and statisticians will be blinded to participants' allocation. The e-pD-Work intervention is self-guided, has a biopsychosocial approach and is multi-component (9 modules: physical exercise, improve sleep, expand relationships, solve problems, improve communication, assertiveness, decision making, manage thoughts and reduce work stress). The e-pD-Work intervention will be implemented in the smartphone of the workers and pivot on an already validated risk predictive algorithm and a DSS that helps workers to develop their own personalized depression prevention plans. Primary outcome will be the rate of major depression measured by CIDI. As secondary outcomes: depressive and anxiety symptomatology measured by PHQ-9 and GAD-7 respectively, the risk probability of depression measured by the predictD risk algorithm, quality of life measured by SF-12 and EuroQol, and cost-effectiveness and cost-utility.
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
- 否
入选标准
- •Have a paid employement
- •PHQ-9 <10 at baseline
排除标准
- •Not have a smartphone and internet for personal use
- •Sick leave for more than 1 month
- •Unable to speak Spanish
- •Documented terminal illness
- •Documented cognitive impairment
- •Documented serious mental illness (psychosis, bipolar, addictions, etc.)
研究组 & 干预措施
e-predicD-Work intervention
In this arm, worker participants will receive an online personalized intervention to prevent depression based on ICTs, risk predictive algorithms and decision support systems (DSS).
干预措施: e-predictD-Work intervention (Behavioral)
m-Health control
In this arm, worker participants will continue receiving the usual care from their health providers. In addition, they will use an App with the same appearance as the e-predictD-Work App but it will only send weekly short messages about stress and general health that will be extracted from brochures and websites of official agencies.
干预措施: Brief psychoeducational messages (Other)
结局指标
主要结局
Rate of major depression measured by the Composite International Diagnostic Interview (CIDI)
时间窗: 12 months
Composite International Diagnostic Interview (CIDI) is a structured diagnostic interview that provides current diagnoses of major depression according to DSM
次要结局
- Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)(12 months)
- Acceptability and satisfaction with the interventions (e-predictD-Work intervention and m-Health control) measured by e-Health Impact Questionnaire(12 months)
- Satisfaction with paid work measured by an adapted version of the Job Content Instrument(12 months)
- Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)(12 months)
- Probability of depression measured by the Spanish predictD risk algorithm(12 months)
- Quality of life measured by SF-12(12 months)
- Cost-effectiveness(12 months)
- Cost-utility(12 months)
- Subgroup analyses(12 months)
研究者
Juan Ángel Bellón
PhD, Medicine
Andalusian Health Service
