Mobile Screening for Major Depressive Disorder in Adults From an Ethnically and Socioeconomically Diverse Population. (MOOD)
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ClinicalTrials.gov Identifier: NCT05989412 |
Recruitment Status :
Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : January 31, 2024
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Condition or disease | Intervention/treatment | Phase |
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Major Depressive Disorder | Other: Patient health questionnaire-9 via the Your Research application | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1786 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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). |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Mobile Screening for Major Depressive Disorder in Adults From an Ethnically and Socioeconomically Diverse Population. |
Estimated Study Start Date : | February 1, 2024 |
Estimated Primary Completion Date : | September 2026 |
Estimated Study Completion Date : | September 2026 |
Arm | Intervention/treatment |
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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.
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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).
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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).
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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. |
- 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.
- 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
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05989412
Contact: Michelle Zandbergen, Msc | +31621509410 | m.zandbergen@erasmusmc.nl | |
Contact: Erik Jansen, Msc | +31 6 48931356 | e.e.l.jansen@erasmusmc.nl |
Principal Investigator: | Inge de Kok, PhD | Erasmus Medical Center |
Responsible Party: | Inge MCM de Kok, Principal Investigator, Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT05989412 |
Other Study ID Numbers: |
NL84280.078.23 |
First Posted: | August 14, 2023 Key Record Dates |
Last Update Posted: | January 31, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Supporting Materials: |
Study Protocol |
Time Frame: | The data will be published within 10 months and will be available from then on. |
Access Criteria: | Open source publication |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Randomized controlled trial Major depressive disorder Screening intervention eHealth Mental health |
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |