Mobile Screening for Major Depressive Disorder in Adults From an Ethnically and Socioeconomically Diverse Population.

Study Overview
=================
Brief Summary
-----------------
Major depressive disorder (MDD) is a mental disorder leading to a variety of emotional and physical problems affecting almost 300 million people worldwide. Long-term treatments for MDD, including medication and therapy, imposes a significant financial burden on society. Mobile-based screening interventions might be a promising approach for effectively reducing MDD symptoms. The investigators hypothesize that the mobile-based screening strategy evaluated in this proposal will substantially reduce the burden of MDD over time, increase participants' quality of life, and decrease MDD-related disparities

Detailed Description
-----------------
The MOOD trial is designed as a prospective, randomized controlled multi-arm trial with three parallel groups: an intervention group that will be screened 4-weekly for MDD for 12 months and receives a referral for MDD diagnosis and treatment after one positive test score on the PHQ-9, an intervention group who will be screened the same as the first group but receives a referral for MDD diagnosis and treatment after three consecutive positive test scores on the PHQ-9 and a control group who do not receive mobile-based screening for MDD. Randomization will be performed by the Your Research application as block randomization with a 1:1:1.5 allocation. The sample size is calculated to be 450 participants in each intervention group and 675 participants in the control group, considering the 5% loss of observations. Dropouts due to adverse events are included in the sample size calculations. The intervention will be powered to demonstrate an effect on the quality of life with 80% power at a 5% significance threshold. It assumes that averted MDD will results in a 0.40 improvement in quality of life (per observational data) and that frequent screening will be effective in 40% of participants with MDD (based on preliminary simulations). Participants will follow the individual screening procedure through the application platform Your Research. Participants will be invited to create a secured personal account, after which they can log in through a website on their computer/laptop or by installing the Your Research app on their tablet or mobile phone. There will be a variety of platforms provided for additional inquiries about the study process, including video calls, chat options, and phone calls. Participants will be recruited through different online and offline strategies to encourage citizens' participation according to different cultural backgrounds. Offline recruitment includes in-person interactions with community members referred to be key figures, posting flyers in GP offices and municipal buildings, video promotion, presentations, and by addressing people personally in public areas. Online recruitment postings will be made on websites, social media networks, and local radio stations. Interested individuals can enroll by visiting the study website, or by initiating an application procedure through the Your Research app. If preferred, contacting the investigators through phone or email is also possible. Eligible participants will subsequently be provided with the patient information form (PIF) as well as an informed consent form. Participants who complete and return the signed consent form will be enrolled and randomized in the trial. The informed consent procedure is conducted digitally by using ValidSign. After randomization, participants will complete the baseline assessment. Recruitment will be closely monitored to ensure that the sample size will be reached. If the sample size is attained, inclusion tactics will be discontinued. Furthermore, to ensure that questionnaire assessments are completed and that participants remain in the study, researchers will automatically send reminders via several contact channels based on the participants' preferences (email, push notifications, SMS). Participants will be compensated for their participation at the end of the study. Depending on the study arm and the number of completed questionnaires the participants can earn up to €50 in gift cards. Participants have the option to withdraw from the study at any moment during the trial. Recruitment will take place between November 2023 and April 2024. Primary and secondary outcome measures for the MOOD study will be collected using mobile-based questionnaires. Data can be collected throughout the study and stored using encrypted digital files within password-protected folders with access limited to a restricted number of researchers. To protect confidentiality, participants will be granted a unique participant identification number upon registration. This number, as well as the associated personal information, is only available to the lead investigator and team members under their supervision. Contact information will be kept separate from any other research data gathered throughout the study. After the study is finished, all data will be safely archived for 15 years within Erasmus Medical Center. Once all outcome data has been collected, it will be exported to a statistics program. Members of the research team will examine and clean the data. All data will be kept and stored in accordance with the Personal Data Protection Act.

Official Title
-----------------
Mobile Screening for Major Depressive Disorder in Adults From an Ethnically and Socioeconomically Diverse Population.

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Other: Patient health questionnaire-9 via the Your Research application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Live in Rotterdam Zuid Have a smartphone Give informed consent Exclusion Criteria: - Is currently treated by a psychologist or psychiatrist

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will randomize 1575 eligible respondents across three arms, in a 1.5:1:1 fashion. The three arms comprise a control arm, a screening arm with limited participant referral for treatment (after three positive test scores on Patient Health questionnaire-9 (PHQ-9) or suicidal ideation), and a screening arm with standard referral for participants with moderate-severe symptoms of major depression (single positive test score on PHQ-9 questionnaire).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>a control arm where the investigators will only measure the quality of life using the EQ-5D questionnaire. This measurement will be performed at the same time as both screening arms. | |
| Experimental: Standard referral<br>a screening arm with standard participant referral for diagnosis at the general practitioner's office (after 1 positive test score on the PHQ-9 questionnaire or suicidal ideation). | Other: Patient health questionnaire-9 via the Your Research application<br>* Both intervention arms will have 4-weekly screening with either lenient follow-up or screening with stricter follow-up for a time period of one year. Data will be collected via an app designed by Your Research which runs on Microsoft Azure server, as the primary of participants' response collection. A dedicated backup system will serve as a secondary data collection.<br>|
| Experimental: Limited referral<br>a screening arm with limited participant referral for diagnosis at the general practitioner's office (after three consecutive positive test scores on the PHQ-9 questionnaire or suicidal ideation). | Other: Patient health questionnaire-9 via the Your Research application<br>* Both intervention arms will have 4-weekly screening with either lenient follow-up or screening with stricter follow-up for a time period of one year. Data will be collected via an app designed by Your Research which runs on Microsoft Azure server, as the primary of participants' response collection. A dedicated backup system will serve as a secondary data collection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life scores over time | Primary outcomes of the trial include participants' quality of life after 24 months as measured by the EQ-5D-5L. EQ-5D-5L will also be assessed at baseline, and again at 6 and 12 months. The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A higher digit number means a worse outcome. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major depressive disorder symptoms | The investigators will also examine the occurrence and severity of symptoms as measured by the PHQ-9. If participants are not referred to their GP due to one or three consecutive positive test scores on PHQ-9 during the course of the 12-month intervention period, PHQ-9 will be evaluated every four weeks for both intervention groups. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression including 9 questions and a 4-scale-based answer option (Not at all, Several days, More than half the days, Nearly every day). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. Scores on the PHQ-9 range from 0 to 27. A higher score means a worse outcome | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomized controlled trial, Major depressive disorder, Screening intervention, eHealth, Mental health