A Combined Digital and Biomarker Diagnostic Aid for Mood Disorders (the Delta Trial): Protocol for an Observational Study

Overview

Journal JMIR Res Protoc

Publisher JMIR Publications

Specialty General Medicine

Date 2020 Aug 11

PMID 32773373

Citations 10

Authors

Tony Olmert

Jason D Cooper

Sung Yeon Sarah Han

Giles Barton-Owen

Lynn Farrag

Emily Bell

Lauren V Friend

Sureyya Ozcan

Nitin Rustogi

Rhian L Preece

Pawel Eljasz

Jakub Tomasik

Daniel Cowell

Sabine Bahn

Affiliations

Soon will be listed here.

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 the potential for novel diagnostic methods that facilitate early and accurate diagnosis of 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 a major depressive disorder (MDD) and achieve more accurate and earlier MDD diagnosis.

Methods: Participants for this ethically approved trial were recruited through the internet, 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 maximize the safety of a trial population that was both relevant to the trial objectives and generalizable. 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. More than 3200 participants completed the digital questionnaire, 924 of whom also submitted DBS samples and a CIDI, whereas a total of 1780 participants completed a 6-month follow-up questionnaire and 1542 completed a 12-month follow-up questionnaire. The 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 patients with mood disorders.

International Registered Report Identifier (irrid): DERR1-10.2196/18453.

Citing Articles

Identification of Predictors of Mood Disorder Misdiagnosis and Subsequent Help-Seeking Behavior in Individuals With Depressive Symptoms: Gradient-Boosted Tree Machine Learning Approach.

Benacek J, Lawal N, Ong T, Tomasik J, Martin-Key N, Funnell E JMIR Ment Health. 2024; 11:e50738.

PMID: 38206660 PMC: 10811571. DOI: 10.2196/50738.

Learnings from user feedback of a novel digital mental health assessment.

Funnell E, Spadaro B, Benacek J, Martin-Key N, Metcalfe T, Olmert T Front Psychiatry. 2022; 13:1018095.

PMID: 36339864 PMC: 9630572. DOI: 10.3389/fpsyt.2022.1018095.

Multimodal Assessment of Schizophrenia and Depression Utilizing Video, Acoustic, Locomotor, Electroencephalographic, and Heart Rate Technology: Protocol for an Observational Study.

Cotes R, Boazak M, Griner E, Jiang Z, Kim B, Bremer W JMIR Res Protoc. 2022; 11(7):e36417.

PMID: 35830230 PMC: 9330209. DOI: 10.2196/36417.

Using decision-analysis modelling to estimate the economic impact of the identification of unrecognised bipolar disorder in primary care: the untapped potential of screening.

Benacek J, Martin-Key N, Spadaro B, Tomasik J, Bahn S Int J Bipolar Disord. 2022; 10(1):15.

PMID: 35680705 PMC: 9184689. DOI: 10.1186/s40345-022-00261-9.

Toward an Extended Definition of Major Depressive Disorder Symptomatology: Digital Assessment and Cross-validation Study.

Martin-Key N, Mirea D, Olmert T, Cooper J, Han S, Barton-Owen G JMIR Form Res. 2021; 5(10):e27908.

PMID: 34709182 PMC: 8587324. DOI: 10.2196/27908.

References

Depue R, Slater J, Klein D, Goplerud E, Farr D . A behavioral paradigm for identifying persons at risk for bipolar depressive disorder: a conceptual framework and five validation studies. J Abnorm Psychol. 1981; 90(5):381-437. DOI: 10.1037//0021-843x.90.5.381. View

Farah M, Gillihan S . The Puzzle of Neuroimaging and Psychiatric Diagnosis: Technology and Nosology in an Evolving Discipline. AJOB Neurosci. 2013; 3(4):31-41. PMC: 3597411. DOI: 10.1080/21507740.2012.713072. View

Van der Lem R, van der Wee N, van Veen T, Zitman F . The generalizability of antidepressant efficacy trials to routine psychiatric out-patient practice. Psychol Med. 2010; 41(7):1353-63. DOI: 10.1017/S0033291710002175. View

Kakuma R, Minas H, van Ginneken N, Dal Poz M, Desiraju K, Morris J . Human resources for mental health care: current situation and strategies for action. Lancet. 2011; 378(9803):1654-63. DOI: 10.1016/S0140-6736(11)61093-3. View

Hatfield D, Ogles B . Why some clinicians use outcome measures and others do not. Adm Policy Ment Health. 2007; 34(3):283-91. DOI: 10.1007/s10488-006-0110-y. View

Preece R, Han S, Bahn S . Proteomic approaches to identify blood-based biomarkers for depression and bipolar disorders. Expert Rev Proteomics. 2018; 15(4):325-340. DOI: 10.1080/14789450.2018.1444483. View

Van Weel-Baumgarten E, Lucassen P . Clinical diagnosis of depression in primary care. Lancet. 2009; 374(9704):1817. DOI: 10.1016/S0140-6736(09)62051-1. View

van Wijngaarden B, Schene A, Koeter M . Family caregiving in depression: impact on caregivers' daily life, distress, and help seeking. J Affect Disord. 2004; 81(3):211-22. DOI: 10.1016/S0165-0327(03)00168-X. View

Woodford J, Farrand P, Bessant M, Williams C . Recruitment into a guided internet based CBT (iCBT) intervention for depression: lesson learnt from the failure of a prevalence recruitment strategy. Contemp Clin Trials. 2011; 32(5):641-8. DOI: 10.1016/j.cct.2011.04.013. View

10.

. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015; 386(9995):743-800. PMC: 4561509. DOI: 10.1016/S0140-6736(15)60692-4. View

11.

Sheehan D, Lecrubier Y, Sheehan K, Amorim P, Janavs J, Weiller E . The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1999; 59 Suppl 20:22-33;quiz 34-57. View

12.

Leuchter A, Cook I, Hunter A, Korb A . A new paradigm for the prediction of antidepressant treatment response. Dialogues Clin Neurosci. 2010; 11(4):435-46. PMC: 3181929. View

13.

Robotham D, Satkunanathan S, Doughty L, Wykes T . Do We Still Have a Digital Divide in Mental Health? A Five-Year Survey Follow-up. J Med Internet Res. 2016; 18(11):e309. PMC: 5141335. DOI: 10.2196/jmir.6511. View

14.

Chan S, Godwin H, Gonzalez A, Yellowlees P, Hilty D . Review of Use and Integration of Mobile Apps Into Psychiatric Treatments. Curr Psychiatry Rep. 2017; 19(12):96. DOI: 10.1007/s11920-017-0848-9. View

15.

Ghaemi S, Sachs G, Chiou A, Pandurangi A, Goodwin K . Is bipolar disorder still underdiagnosed? Are antidepressants overutilized?. J Affect Disord. 1999; 52(1-3):135-44. DOI: 10.1016/s0165-0327(98)00076-7. View

16.

Rush A, Warden D, Wisniewski S, Fava M, Trivedi M, Gaynes B . STAR*D: revising conventional wisdom. CNS Drugs. 2009; 23(8):627-47. DOI: 10.2165/00023210-200923080-00001. View

17.

Bauer A, Baldwin S, Anguera J, Arean P, Atkins D . Comparing Approaches to Mobile Depression Assessment for Measurement-Based Care: Prospective Study. J Med Internet Res. 2018; 20(6):e10001. PMC: 6030575. DOI: 10.2196/10001. View

18.

Walters K, Buszewicz M, Weich S, King M . Help-seeking preferences for psychological distress in primary care: effect of current mental state. Br J Gen Pract. 2008; 58(555):694-8. PMC: 2553529. DOI: 10.3399/bjgp08X342174. View

19.

Tyrer P . Are general practitioners really unable to diagnose depression?. Lancet. 2009; 374(9690):589-90. DOI: 10.1016/S0140-6736(09)61156-9. View

20.

. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001; 69(3):89-95. DOI: 10.1067/mcp.2001.113989. View