Clinical trial NCT04858737: Personalized Prevention of Depression in the Workplace (e-pD-Work)
Official title: Prevention of Depression in the Workplace Through a Personalized Intervention Based on Risk Algorithms, ICTs and Decision Support Systems: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Keywords: Depression
Primary prevention
Randomized controlled trial
m-Health
App
Workers
Lead sponsor: The Mediterranean Institute for the Advance of Biotechnology and Health Research
Sponsor class: OTHER
Collaborators: name: Preventive Services and Health Promotion Research Network
name: Institute of Biomedical Research in Málaga (IBIMA)
name: Andalusian Regional Ministry of Health
name: European Regional Development Fund
name: University of Malaga
First posted: 2021-04-26
Enrollment: 1054
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.)

Primary outcomes:
measure: Rate of major depression measured by the Composite International Diagnostic Interview (CIDI)
timeFrame: 12 months
Secondary outcomes:
measure: Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 months
measure: Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)
timeFrame: 12 months
measure: Probability of depression measured by the Spanish predictD risk algorithm
timeFrame: 12 months
measure: Quality of life measured by SF-12
timeFrame: 12 months
measure: Satisfaction with paid work measured by an adapted version of the Job Content Instrument
timeFrame: 12 months
measure: Acceptability and satisfaction with the interventions (e-predictD-Work intervention and m-Health control) measured by e-Health Impact Questionnaire
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
measure: Cost-utility
timeFrame: 12 months
measure: Subgroup analyses
timeFrame: 12 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Juan Bellon Saameño
Study officials:
affiliation: Andalusian Health Service
name: Juan Á Bellón, PhD
role: PRINCIPAL_INVESTIGATOR
References: