Depressione-pD-WorkNCT04858737
Personalized Prevention of Depression in the Workplace (e-pD-Work)
A study testing e-predictD-Work intervention and Brief psychoeducational messages in people with Depression, run by The Mediterranean Institute for the Advance of Biotechnology and Health Research at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depression
- What is being tested?
- e-predictD-Work intervention and Brief psychoeducational messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,054 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a paid employement
- PHQ-9 <10 at baseline
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Depression in the Workplace Through a Personalized Intervention Based on Risk Algorithms, ICTs and Decision Support Systems: Randomized Controlled Trial
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.
- Conditions
- Depression
- Being tested
- e-predictD-Work intervention, Brief psychoeducational messages
- Keywords
- Depression, Primary prevention, Randomized controlled trial, m-Health, App, Workers
- Medical subject headings
- Depression, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-predictD-Work interventionBehavioural
The intervention is based on validated risk algorithms to predict depression and includes: 1) Mobile applications as main user's interface; 2) a DSS that helps worker participants to develop their own personalized plans to prevent (PPP) depression; 3) nine intervention modules (the core of the system) including activities to prevent depression, to be proposed by the DSS and chosen by the participants. The intervention is biopsychosocial and multi-component, including the following modules: physical exercise, improve sleep, expand relationships, solve problems, improve communication, assertiveness, decision making, manage thoughts and reduce work stress. Worker participants will implement the recommendations and the tool will monitor these actions, offering feedback to improve their PPP at 6 and 12 months.
Brief psychoeducational messagesOther
The intervention consists of an App that weekly send short messages about stress and general health that will be extracted from brochures and websites of official agencies.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: e-predictD-Work intervention |
| 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. Receives: Other: Brief psychoeducational messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major depression measured by the Composite International Diagnostic Interview (CIDI)
Composite International Diagnostic Interview (CIDI) is a structured diagnostic interview that provides current diagnoses of major depression according to DSM
Measured: 12 months
Secondary outcomes (9)
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) measures symptoms of depression through 9 items, each of which is scored 0 ('not at all') to 3 ('nearly every day'). Low scores are equivalent to less symptoms of depression, the scale range is 0 to 27 (9 items).
Measured: 12 months
Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)
The General Anxiety Questionnaire (GAD-7) measures generalized anxiety disorder through 7 items, each of which is scored 0 ('not at all') to 3 ('nearly every day'). Low scores are equivalent to less symptoms of anxiety, the scale range is 0 to 21 (7 items).
Measured: 12 months
Probability of depression measured by the Spanish predictD risk algorithm
The Spanish predictD risk algorithm reports a probability of suffering depression in the next 12 months measured by 13 risk factors. Scores range from 0% to 100%.
Measured: 12 months
Quality of life measured by SF-12
The 12-item Short Form (SF-12) measures quality of life related to physical health and quality of life related to mental health. Scores on the scales range from 0 to 100. Higher scores are equivalent to better health-related quality of life.
Measured: 12 months
Satisfaction with paid work measured by an adapted version of the Job Content Instrument
The Job Content Instrument measures psychological demands, decision latitude, social support, physical demands, and job insecurity with a total of seven items. The first four are distributed on a 4-point Likert scale ranging from 'Often to Almost never / never), one of them is distributed on a dichotomous scale (yes / no), and the latter on a 4-point Likert scale ranging from 'Not at all to A lot'.
Measured: 12 months
Acceptability and satisfaction with the interventions (e-predictD-Work intervention and m-Health control) measured by e-Health Impact Questionnaire
The e-Health Impact Questionnaire (e-HIQ) assesses the effects of websites containing health information. The e-HIQ questionnaire consists of two independently administered and scored parts. In the first part items represent general attitudes towards using the internet to access health information. In the second part items measure a person's ease with using online information, particularly emphasising a person's openness to learning and gaining support from other peoples experiences. Both parts of the questionnaire have a five point response category for all items ranging from 'Strongly disagree to Strongly agree'.
Measured: 12 months
Cost-effectiveness
It will be conducted from two perspectives: (1) a societal perspective and (2) a National Health System perspective. We will calculate incremental cost-effectiveness ratio (ICER) using the incremental cost (difference in costs between arms) divided by incremental effectiveness (difference in the number of diagnoses of major depression between arms).
Measured: 12 months
Cost-utility
It will be conducted from two perspectives: (1) a societal perspective and (2) a National Health System perspective. We will calculate incremental cost-effectiveness ratio (ICER) using the incremental cost (difference in costs between arms) divided by incremental QALYs (difference in QALYs between arms). Quality-adjusted life years (QALYs) will be measured using the EuroQol five questionnaire (EuroQol-5D).
Measured: 12 months
Subgroup analyses
Pre-specified subgroup analyses will be conducted according to age, sex, education level, screening lifetime depression, employment type, work sector, years in employment, number of workers in the company, type of employment contract, work schedule, number of weekly hours worked and type of salary, as well as baseline measurements of anxiety and depression symptoms, risk level for depression, physical and mental quality of life, physical activity level, insomnia, social support, assertiveness, troubled relationship, and difficulties communicating or making decisions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jun 2021
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mediterranean Institute for the Advance of Biotechnology and Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network, Biomedical Research Institute of Málaga, Andalusian Regional Ministry of Health, European Regional Development Fund, University of Malaga
- Responsible party
- Principal investigator, Juan Ángel Bellón, Andalusian Health Service
- Investigators
- Juan Á Bellón, PhD, Principal investigator, Andalusian Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858737
- Sponsor's protocol ID
- PI18/01307
- Acronym
- e-pD-Work
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2021
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Depression in the Workplace Through a Personalized Intervention Based on Risk Algorithms, ICTs and Decision Support Systems: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04858737
- Acronym / sponsor ID
- e-pD-Work / PI18/01307
- Conditions
- Depression
- Keywords
- Depression, Primary prevention, Randomized controlled trial, m-Health, App, Workers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,054 participants (actual)
- Lead sponsor
- The Mediterranean Institute for the Advance of Biotechnology and Health ResearchUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network, Biomedical Research Institute of Málaga, Andalusian Regional Ministry of Health, European Regional Development Fund, University of Malaga
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-predicD-Work intervention | Experimental | Behavioral: e-predictD-Work interventionIn this arm, worker participants will receive an online personalized intervention to prevent depression based on ICTs, risk predictive algorithms and decision support systems (DSS). |
| m-Health control | Active comparator | Other: Brief psychoeducational messagesIn 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have a paid employement
- PHQ-9 <10 at baseline
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-predictD-Work interventionThe intervention is based on validated risk algorithms to predict depression and includes: 1) Mobile applications as main user's interface; 2) a DSS that helps worker participants to develop their own personalized plans to prevent (PPP) depression; 3) nine intervention modules (the core of the system) including activities to prevent depression, to be proposed by the DSS and chosen by the participants. The intervention is biopsychosocial and multi-component, including the following modules: physical exercise, improve sleep, expand relationships, solve problems, improve communication, assertiveness, decision making, manage thoughts and reduce work stress. Worker participants will implement the recommendations and the tool will monitor these actions, offering feedback to improve their PPP at 6 and 12 months. | Behavioural | e-predicD-Work intervention |
| Brief psychoeducational messagesThe intervention consists of an App that weekly send short messages about stress and general health that will be extracted from brochures and websites of official agencies. | Other | m-Health control |
Primary outcome
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
9 secondary outcomes
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 months
Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)
Time frame: 12 months
Probability of depression measured by the Spanish predictD risk algorithm
Time frame: 12 months
Quality of life measured by SF-12
Time frame: 12 months
Satisfaction with paid work measured by an adapted version of the Job Content Instrument
Time frame: 12 months
Acceptability and satisfaction with the interventions (e-predictD-Work intervention and m-Health control) measured by e-Health Impact Questionnaire
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
Cost-utility
Time frame: 12 months
Subgroup analyses
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Á Bellón, PhD principal investigator
Andalusian Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-predictD-Work intervention and Brief psychoeducational messages in people with Depression, run by The Mediterranean Institute for the Advance of Biotechnology and Health Research at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major depression measured by the Composite International Diagnostic Interview (CIDI) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.