Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones– the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial

BMC Psychiatry

Lars Vedel Kessing¹  Jakob Bardram²  Ellen Margrethe Christensen¹  Mads Frost²  Maj Vinberg¹  Maria Faurholt-Jepsen¹ 

[1] Psychiatric Center Copenhagen, Rigshospitalet, Blegdamsvej 9, Copenhagen, DK-2100, Denmark;Monsenso ApS, Rued Langgaards Vej 7, Copenhagen, 2300, Denmark

关键词: Electronic monitoring;    The Monsenso system;    The MONARCA II trial;    Illness activity;    Depressive and manic symptoms;    Smartphone;    Randomized controlled trial;    Bipolar disorder;   

Others  :  1092105
DOI  :  10.1186/s12888-014-0309-5

 received in 2014-09-30, accepted in 2014-10-21,  发布年份 2014

【 摘 要 】

Background

Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed.

Recently, the MONARCA I randomized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms. The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purposes, but had fewer manic symptoms during the trial. It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage, social activity, physical activity, and mobility. The Monsenso system, for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial.

Methods

The MONARCA II trial uses a randomized controlled single-blind parallel-group design. Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder, Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for a 9-month trial period. The trial was started in September 2014 and recruitment is ongoing. The outcomes are: differences in depressive and manic symptoms; rate of depressive and manic episodes (primary); automatically generated objective data on measures of illness activity; number of days hospitalized; psychosocial functioning (secondary); perceived stress; quality of life; self-rated depressive symptoms; self-rated manic symptoms; recovery; empowerment and adherence to medication (tertiary) between the intervention group and the control group during the trial. Ethical permission has been obtained. Positive, neutral and negative findings will be published.

Discussion

If the system is effective in reducing depressive and/or manic symptoms (and other symptoms of bipolar disorder) and the rate of episodes, there will be basis for extending the use to the treatment of bipolar disorder in general and in larger scale.

Trial registration

ClinicalTrials.gov NCT02221336 webcite. Registered 26^th of September 2014.

【 授权许可】

   
2014 Faurholt-Jepsen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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【 参考文献 】

• [1]Vestergaard P, Schou M: Prospective studies on a lithium cohort. 1. General features. Acta Psychiatr Scand 1988, 78:421-426.
• [2]Hansen HV, Kessing LV: Adherence to antidepressant treatment. Expert Rev Neurother 2007, 7:57-62.
• [3]Kessing LV, Søndergård L, Kvist K, Andersen PK: Adherence to lithium in naturalistic settings: results from a nationwide pharmacoepidemiological study. Bipolar Disord 2007, 9:730-736.
• [4]Morriss RK, Faizal MA, Jones AP, Williamson PR, Bolton C, McCarthy JP: Interventions for helping people recognise early signs of recurrence in bipolar disorder. Cochrane Database Syst Rev 2007, 24:CD004854.
• [5]Berk M, Malhi GS, Hallam K, Gama CS, Dodd S, Andreazza AC, Frey BN, Kapczinski F: Early intervention in bipolar disorders: clinical, biochemical and neuroimaging imperatives. J Affect Disord 2009, 114:1-13.
• [6][http:/ / www.pewinternet.org/ files/ old-media/ Files/ Reports/ 2012/ PIP_Cell_Phone_Internet_Access.pdf] webcite Smith A: Cell internet use 2012. A project of the Pew Research Center. In ᅟ. ; ᅟ. Available from website at: .
• [7]Bopp JM, Miklowitz DJ, Goodwin GM, Stevens W, Rendell JM, Geddes JR: The longitudinal course of bipolar disorder as revealed through weekly text messaging: a feasibility study. Bipolar Disord 2010, 12:327-334.
• [8]Depp CA, Mausbach B, Granholm E, Cardenas V, Ben-Zeev D, Patterson TL, Lebowitz BD, Jeste DV: Mobile interventions for severe mental illness: design and preliminary data from three approaches. J Nerv Ment Dis 2010, 198:715-721.
• [9]Mutschler J, Von Zitzewitz F, Rossler W, Grosshans M: Application of electronic diaries in patients with schizophrenia and bipolar disorders. Psychiatr Danub 2012, 24:206-210.
• [10]Whybrow PC, Grof P, Gyulai L, Rasgon N, Glenn T, Bauer M: The electronic assessment of the longitudinal course of bipolar disorder: the chronorecord software. Pharmacopsychiatry 2003, 36(Suppl 3):S244-S249.
• [11]Chinman M, Young AS, Schell T, Hassell J, Mintz J: Computer-assisted self-assessment in persons with severe mental illness. J Clin Psychiatry 2004, 65:1343-1351.
• [12]Lieberman DZ, Swayze S, Goodwin FK: An automated Internet application to help patients with bipolar disorder track social rhythm stabilization. Psychiatr Serv Wash DC 2011, 62:1267-1269.
• [13]Bauer M, Grof P, Gyulai L, Rasgon N, Glenn T, Whybrow PC: Using technology to improve longitudinal studies: self-reporting with ChronoRecord in bipolar disorder. Bipolar Disord 2004, 6:67-74.
• [14]Adli M, Whybrow PC, Grof P, Rasgon N, Gyulai L, Baethge C, Glenn T, Bauer M: Use of Polypharmacy and Self-reported Mood in Outpatients with Bipolar Disorder. 2005.
• [15]Bauer M, Rasgon N, Grof P, Gyulai L, Glenn T, Whybrow PC: Does the use of an automated tool for self-reporting mood by patients with bipolar disorder bias the collected data? MedGenMed 2005, 7:21.
• [16]Bauer M, Grof P, Rasgon N, Glenn T, Alda M, Priebe S, Ricken R, Whybrow PC: Mood charting and technology: new approach to monitoring patients with mood disorders. Curr Psychiatry Rev 2006, 2(4):423-429.
• [17]Bauer M, Glenn T, Grof P, Pfennig A, Rasgon NL, Marsh W, Munoz RA, Sagduyu K, Alda M, Quiroz D, Sasse J, Whybrow PC: Self-reported data from patients with bipolar disorder: frequency of brief depression. J Affect Disord 2007, 101:227-233.
• [18]Bauer M, Wilson T, Neuhaus K, Sasse J, Pfennig A, Lewitzka U, Grof P, Glenn T, Rasgon N, Bschor T, Whybrow PC: Self-reporting software for bipolar disorder: validation of ChronoRecord by patients with mania. Psychiatry Res 2008, 159:359-366.
• [19]Depp CA, Kim DH, De Dios LV, Wang V, Ceglowski J: A pilot study of mood ratings captured by mobile phone versus paper-and-pencil mood charts in bipolar disorder. J Dual Diagn 2012, 8:326-332.
• [20]Faurholt-Jepsen M: Daily Electronic Self-monitoring on Smartphones in Bipolar Disorder - The MONARCA Trial: A Randomized, Placebo-controlled, Single-blind, Parallel Group Trial. 2014.
• [21]Weinstock LM, Miller IW: Functional impairment as a predictor of short-term symptom course in bipolar I disorder. Bipolar Disord 2008, 10:437-442.
• [22]Kupfer DJ, Weiss BL, Foster G, Detre TP, McPartland R: Psychomotor activity in affective states. Arch Gen Psychiatry 1974, 30:765-768.
• [23]Kuhs H, Reschke D: Psychomotor activity in unipolar and bipolar depressive patients. Psychopathology 1992, 25:109-116.
• [24]Faurholt-Jepsen M, Brage S, Vinberg M, Christensen EM, Knorr U, Jensen HM, Kessing LV: Differences in psychomotor activity in patients suffering from unipolar and bipolar affective disorder in the remitted or mild/moderate depressive state. J Affect Disord 2012, 141:457-463.
• [25]Bardram J, Frost M, Szanto K, Margu G: The MONARCA self-assessment system: a persuasive personal monitoring system for bipolar patients. In Conference Proceedings: Proceeding IHI ’12 Proceedings of the 2nd ACM SIGHIT. ACM, New York, NY, USA; 2012:21-30.
• [26]Bardram JE, Frost M, Szánto K, Faurholt-Jepsen M, Vinberg M, Kessing LV: Designing mobile health technology for bipolar disorder: a field trial of the monarca system. In Conference Proceedings: In Proceedings of the SIGCHI Conference on Human Factors in Computing Systems. ᅟ, New York, NY, USA; 2013:2627-2636.
• [27]Faurholt-Jepsen M, Vinberg M, Christensen EM, Frost M, Bardram J, Kessing LV: Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder–the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial.BMJ Open 2013, 3:ᅟ. doi:10.1136/bmjopen-2013-003353.
• [28]Faurholt-Jepsen M, Frost M, Vinberg M, Christensen EM, Bardram JE, Kessing LV: Smartphone data as objective measures of bipolar disorder symptoms. Psychiatry Res 2014, 217:124-127.
• [29]Hamilton M: Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 1967, 6:278-296.
• [30]Young RC, Biggs JT, Ziegler VE, Meyer DA: A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry J Ment Sci 1978, 133:429-435.
• [31]Faurholt-Jepsen M: Smartphone Data as an Electronic Biomarker of Illness Activity in Bipolar Disorder. 2014.
• [32]Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c869.
• [33]Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148:295-309.
• [34]Chan A-W, Tetzlaff JM, Altman DG, Dickersin K, Moher D: SPIRIT 2013: new guidance for content of clinical trial protocols. Lancet 2013, 381:91-92.
• [35]Goodwin GM: Evidence-based guidelines for treating bipolar disorder: revised second edition–recommendations from the British association for psychopharmacology. J Psychopharmacol Oxf Engl 2009, 23:346-388.
• [36]Kessing LV, Hansen HV, Hvenegaard A, Christensen EM, Dam H, Gluud C, Wetterslev J: Treatment in a specialised out-patient mood disorder clinic v. standard out-patient treatment in the early course of bipolar disorder: randomised clinical trial. Br J Psychiatry J Ment Sci 2013, 202:212-219.
• [37]Wing JK, Babor T, Brugha T, Burke J, Cooper JE, Giel R, Jablenski A, Regier D, Sartorius N: SCAN. Schedules for clinical assessment in neuropsychiatry. Arch Gen Psychiatry 1990, 47:589-593.
• [38]Rosa AR, Sánchez-Moreno J, Martínez-Aran A, Salamero M, Torrent C, Reinares M, Comes M, Colom F, Van Riel W, Ayuso-Mateos JL, Kapczinski F, Vieta E: Validity and reliability of the functioning assessment short test (FAST) in bipolar disorder. Clin Pract Epidemiol Ment Health 2007, 3:5. BioMed Central Full Text
• [39]Cohen S, Kamarck T, Mermelstein R: A global measure of perceived stress. J Health Soc Behav 1983, 24:385-396.
• [40]Development of the World health organization WHOQOL-BREF quality of life assessment Psychol Med 1998, 28:551-558.
• [41]Bech P, Olsen LR: Discovering depression. Ugeskr Laeger 2001, 163:1980-1982.
• [42]Bech P, Rasmussen NA, Olsen LR, Noerholm V, Abildgaard W: The sensitivity and specificity of the major depression inventory, using the present state examination as the index of diagnostic validity. J Affect Disord 2001, 66:159-164.
• [43]Olsen LR, Jensen DV, Noerholm V, Martiny K, Bech P: The internal and external validity of the major depression inventory in measuring severity of depressive states. Psychol Med 2003, 33:351-356.
• [44]Altman EG, Hedeker D, Peterson JL, Davis JM: The altman self-rating mania scale. Biol Psychiatry 1997, 42:948-955.
• [45]Corrigan PW, Salzer M, Ralph RO, Sangster Y, Keck L: Examining the factor structure of the recovery assessment scale. Schizophr Bull 2004, 30:1035-1041.
• [46]Thompson K, Kulkarni J, Sergejew AA: Reliability and validity of a new medication adherence rating scale (MARS) for the psychoses. Schizophr Res 2000, 42:241-247.
• [47]Rogers ES, Chamberlin J, Ellison ML, Crean T: A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv 1997, 48:1042-1047.
• [48]Schulz KF, Grimes DA: Allocation concealment in randomised trials: defending against deciphering. Lancet 2002, 359:614-618.
• [49]Schulz KF, Grimes DA: Unequal group sizes in randomised trials: guarding against guessing. Lancet 2002, 359:966-970.
• [50]Meinert C: Clinical Trials: Design, Conduct, and Analysis. 2nd edition. Oxford University Press, New York; 2012.
• [51]Faurholt-Jepsen M: Electronic Self-monitoring Using IT Platforms in Adult Patients with Bipolar Disorder: A Systematic Review. 2014.