Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 28, 2020
Date Accepted: Apr 26, 2020
Developing a Combined Digital and Biomarker Diagnostic Aid for Mood Disorders: Protocol and Recruitment for the Delta Trial
ABSTRACT
Background:
Mood disorders affect hundreds of millions of people worldwide, imposing a substantial medical and economic burden. Existing diagnostic methods for mood disorders often result in a delay until accurate diagnosis, exacerbating the challenges of these disorders. Advances in digital tools for psychiatry and understanding the biological basis of mood disorders offer potential for novel diagnostic methods that facilitate early and accurate diagnosis for patients.
Objective:
The Delta Trial was launched to develop an algorithm-based diagnostic aid combining symptom data and proteomic biomarkers to reduce the misdiagnosis of bipolar disorder (BD) as major depressive disorder (MDD) and achieve more accurate and earlier diagnosis of MDD.
Methods:
Participants for this ethically approved trial were recruited online, mainly through Facebook advertising. Participants were then screened for eligibility, consented to participate, and completed an adaptive digital questionnaire that was designed and created for the trial on a purpose-built digital platform. A subset of these participants was selected to provide dried blood spot (DBS) samples and undertake a World Health Organization World Mental Health Composite International Diagnostic Interview (CIDI). Inclusion and exclusion criteria were chosen to maximise the safety of a trial population that was both relevant to the trial objectives and generalisable. To provide statistical power and validation sets for the primary and secondary objectives, 840 participants were required to complete the digital questionnaire, submit DBS samples, and undertake a CIDI.
Results:
The Delta Trial is now complete. Over 3,200 participants completed the digital questionnaire, 924 of whom also submitted DBS samples and a CIDI, while a total of 1,780 participants completed a six-month follow-up questionnaire and 1,542 completed a twelve-month follow-up questionnaire. Analysis of the trial data is now underway.
Conclusions:
If a diagnostic aid is able to improve the diagnosis of BD and MDD, it may enable earlier treatment for mood disorder patients.
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