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

January 30, 2024 updated by: Inge MCM de Kok, Erasmus Medical Center
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 2:1:1 allocation and stratification for age, gender and living area.

The intervention will be powered to demonstrate an effect on quality of life after 12 months with 80% power at a 5% significance threshold. It assumes that averted MDD will result in a 0.40 improvement in quality of life and that frequent screening will be effective in 40% of participants with MDD. Furthermore, we conservatively assume a cumulative incidence of MDD during 12 months of 10%, based on a three times increased rate of unemployment in the intervention area and therefore three times increased risk of developing MDD. An additional adjustment for an assumed 40% spontaneously remission rate within 12 months was applied. With a correlation coefficient of 0.8, the design effect for using the baseline measurement becomes 0.36. Therefore, 714 people are required in control and combined intervention arms. Yielding a total sample size of 1,428 people (2:1:1 randomization). The intervention will be powered to demonstrate an effect on quality of life with 80% power at a 5% significance threshold. To compensate for the potential 20% differential loss of follow-up in both arms due to adverse events, we aim to recruit an additional 179 participants for the control arm and 179 participants for the intervention arm (1:1 between both intervention groups). To reach our goal we therefore need 1786 participants.

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 January 2024 and December 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.

Study Type

Interventional

Enrollment (Estimated)

1786

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 for depressive symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
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
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
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.
Experimental: Limited referral
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life scores after 12 months
Time Frame: 12 months
Primary outcomes of the trial include participants' quality of life after 12 months as measured by the EQ-5D-5L between intervention and no intervention. Although only 3 out of 5 items on this questionnaire relate to mental problems and social functioning, evidence suggests that it is highly sensitive to MDD when used in community research settings (Short et al., 2021). Because the fifth question (''How anxious or depressed are you today?'') of the EQ-5D has the strongest relation with mental health, we will report outcomes on that question separately as well.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major depressive disorder symptoms
Time Frame: 12 months

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 12-month intervention period, PHQ-9 will be evaluated every four weeks for both intervention groups. Furthermore, population differences will be evaluated based on socio-demographic characteristics (including age, gender, ethnicity, education level, and employment status).

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life follow up
Time Frame: 24 months
Other study parameters include participants' quality of life after 24 months as measured by the EQ-5D-5L between two intervention groups and the control group. It will also provide information regarding the duration and severity of MDD symptoms across participants in both screening arms. Furthermore, the risk of measuring differences in referrals between two intervention groups will also be evaluated by comparing both screening arms.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Inge de Kok, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL84280.078.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data of participants that did not grant permission to reuse their data for future research will have to be removed. Furthermore, further pseudonymisation and/or aggregation of the pseudonymised dataset would be required to secure the privacy of the participants and avoid indirect identification.

The accessibility of the collected data could be important for potential follow-up research of this project and/or similar national/international projects that would like to perform analyses on our data because not much is known yet on the implementation of screening for MDD.

IPD Sharing Time Frame

The data will be published within 10 months and will be available from then on.

IPD Sharing Access Criteria

Open source publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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