Major Depressive Disorder Clinical Trial
— MOODOfficial title:
Mobile Screening for Major Depressive Disorder in Adults From an Ethnically and Socioeconomically Diverse Population.
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
Status | Not yet recruiting |
Enrollment | 1786 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Erasmus Medical Center |
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life follow up | 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 | |
Primary | Quality of life scores after 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 | 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 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 |
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