Skip to main content
Clinical Trials/NCT04858737
NCT04858737
Active, not recruiting
Not Applicable

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 site in 1 country1,054 target enrollmentJune 1, 2021
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
The Mediterranean Institute for the Advance of Biotechnology and Health Research
Enrollment
1054
Locations
1
Primary Endpoint
Rate of major depression measured by the Composite International Diagnostic Interview (CIDI)
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The Mediterranean Institute for the Advance of Biotechnology and Health Research
Responsible Party
Principal Investigator
Principal Investigator

Juan Ángel Bellón

PhD, Medicine

Andalusian Health Service

Eligibility Criteria

Inclusion Criteria

  • Have a paid employement
  • PHQ-9 \<10 at baseline

Exclusion Criteria

  • 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.)

Outcomes

Primary Outcomes

Rate of major depression measured by the Composite International Diagnostic Interview (CIDI)

Time Frame: 12 months

Composite International Diagnostic Interview (CIDI) is a structured diagnostic interview that provides current diagnoses of major depression according to DSM

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials