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临床试验/NCT04858737
NCT04858737Unknown不适用

Prevention of Depression in the Workplace Through a Personalized Intervention Based on Risk Algorithms, ICTs and Decision Support Systems: Randomized Controlled Trial

The Mediterranean Institute for the Advance of Biotechnology and Health Research1 个研究点 分布在 1 个国家目标入组 1,054 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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

发起方
The Mediterranean Institute for the Advance of Biotechnology and Health Research
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Ángel Bellón

PhD, Medicine

Andalusian Health Service

研究点 (1)

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