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

NCT05989412 | Enrolling By Invitation

• 1 other identifier: NL84280.078.23
• Study Type: interventional
• Target: 1,786
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depressive Disorder

Keywords

Randomized controlled trial; Major depressive disorder; Screening intervention; eHealth; Mental health

Outcome Measures

Primary Outcomes (1)

• Quality of life scores after 12 months

  Primary outcomes of the trial include participants' quality of life after 12 months as measured by the The 5-level EuroQuol-5D (EQ-5D-5L) between two intervention groups and the control group. EQ-5D-5L is being used as a 5-item self-report validated questionnaire for assessing health and health-related quality of life across five core dimensions (5D): mobility, self-care, daily activities, pain/discomfort, and anxiety/depression and has been widely used to measure the quality of life. Items are scored on zero-five levels of severity (5L) for each dimension. Higher scores represent decreased quality of life on that particular day with a minimum score of 5 and a maximum score of 25.

  12 months

Secondary Outcomes (1)

• Major depressive disorder symptoms

  12 months

Other Outcomes (1)

• Quality of life follow up

  24 months

Study Arms (3)

Control arm

NO INTERVENTION

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.

Standard referral

EXPERIMENTAL

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

Limited referral

EXPERIMENTAL

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

Interventions

Patient health questionnaire-9 via the Your Research application OTHER

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.

Limited referral; Standard referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old Live in Rotterdam Zuid
• Have access to a smartphone or tablet.
• Give informed consent

You may not qualify if:

• \- Is currently treated by a psychologist or psychiatrist for depressive symptoms

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (18)

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  PMID: 24273703 BACKGROUND

• Siu AL; US Preventive Services Task Force (USPSTF); Bibbins-Domingo K, Grossman DC, Baumann LC, Davidson KW, Ebell M, Garcia FA, Gillman M, Herzstein J, Kemper AR, Krist AH, Kurth AE, Owens DK, Phillips WR, Phipps MG, Pignone MP. Screening for Depression in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jan 26;315(4):380-7. doi: 10.1001/jama.2015.18392.

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• Yildiz B, Schuring M, Knoef MG, Burdorf A. Chronic diseases and multimorbidity among unemployed and employed persons in the Netherlands: a register-based cross-sectional study. BMJ Open. 2020 Jul 2;10(7):e035037. doi: 10.1136/bmjopen-2019-035037.

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• Zandbergen MME, Jansen EEL, Jabbarian LJ, de Koning HJ, de Kok IMCM. A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocol. BMC Psychol. 2024 Dec 18;12(1):742. doi: 10.1186/s40359-024-02230-6.

  PMID: 39695914 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Psychological Well-Being

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Inge de Kok, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The investigators will randomize 1786 eligible respondents across three arms, in a 2:1:1 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).

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be published within 10 months and will be available from then on.
• Access Criteria: Open source publication

Locations

NL (1)