Skip to main content Accessibility help
×
Home

Daily electronic self-monitoring in bipolar disorder using smartphones – the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial

  • M. Faurholt-Jepsen (a1), M. Frost (a2), C. Ritz (a3), E. M. Christensen (a1), A. S. Jacoby (a1), R. L. Mikkelsen (a1), U. Knorr (a1), J. E. Bardram (a2), M. Vinberg (a1) and L. V. Kessing (a1)...

Abstract

Background

The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder.

Method

A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18–60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups.

Results

Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval −0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group.

Conclusions

These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

Copyright

Corresponding author

* Address for correspondence: Dr M. Faurholt-Jepsen, The Copenhagen Clinic for Affective Disorder, Psychiatric Centre Copenhagen, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark. (Email: maria@faurholt-jepsen.dk)

References

Hide All
Altman, EG, Hedeker, D, Peterson, JL, Davis, JM (1997). The Altman self-rating mania scale. Biological Psychiatry 42, 948955.
Baldessarini, RJ, Salvatore, P, Kaur Khalsa, H-M, Gebre-Medhin, P, Imaz, H, González-Pinto, A, Perez, J, Cruz, N, Maggini, C, Tohen, M (2010). Morbidity in 303 first-episode bipolar I disorder patients. Bipolar Disorders 12, 264270.
Bardram, J, Frost, M, Szanto, K, Margu, G (2012). The MONARCA self-assessment system: a persuasive personal monitoring system for bipolar patients. In Proceeding IHI ’12. Proceedings of the 2nd ACM SIGHIT, ACM, New York, NY, USA, 2012, pp. 2130.
Bardram, JE, Frost, M, Szánto, K, Faurholt-Jepsen, M, Vinberg, M, Kessing, LV (2013). Designing mobile health technology for bipolar disorder: a field trial of the Monarca system. In Proceedings of the SIGCHI Conference on Human Factors in Computing Systems, New York, NY, USA, 2013, pp. 26272636.
Bauer, MS, Crits-Christoph, P, Ball, WA, Dewees, E, McAllister, T, Alahi, P, Cacciola, J, Whybrow, PC (1991). Independent assessment of manic and depressive symptoms by self-rating. Scale characteristics and implications for the study of mania. Archives of General Psychiatry 48, 807812.
Bech, P, Olsen, LR (2001). Discovering depression. Ugeskrift for laeger 163, 19801982.
Bech, P, Rasmussen, NA, Olsen, LR, Noerholm, V, Abildgaard, W (2001). The sensitivity and specificity of the major depression inventory, using the present state examination as the index of diagnostic validity. Journal of Affective Disorders 66, 159164.
Bonsall, MB, Wallace-Hadrill, SMA, Geddes, JR, Goodwin, GM, Holmes, EA (2012). Nonlinear time-series approaches in characterizing mood stability and mood instability in bipolar disorder. Proceedings of the Royal Society of London, Series B: Biological Sciences 279, 916924.
Bopp, JM, Miklowitz, DJ, Goodwin, GM, Stevens, W, Rendell, JM, Geddes, JR (2010). The longitudinal course of bipolar disorder as revealed through weekly text messaging: a feasibility study. Bipolar Disorders 12, 327334.
Boutron, I, Moher, D, Altman, DG, Schulz, KF, Ravaud, P (2008). Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Annals of Internal Medicine 148, 295309.
Cohen, S, Kamarck, T, Mermelstein, R (1983). A global measure of perceived stress. Journal of Health and Social Behavior 24, 385396.
Colom, F, Vieta, E, Martinez-Aran, A, Reinares, M, Goikolea, JM, Benabarre, A, Torrent, C et al. (2003). A randomized trial on the efficacy of group psychoeducation in the prophylaxis of recurrences in bipolar patients whose disease is in remission. Archives of General Psychiatry 60, 402407.
De Assis da Silva, R, Mograbi, DC, Silva Silveira, LA, Santos Nunes, AL, Novis, FD, Landeira-Fernandez, J, Cheniaux, E (2015). Insight across the different mood states of bipolar disorder. Psychiatric Quarterly. Published online: 18 January 2015. doi:10.1007/s11126-015-9340-z.
Depp, CA, Kim, DH, de Dios, LV, Wang, V, Ceglowski, J (2012). A pilot study of mood ratings captured by mobile phone versus paper-and-pencil mood charts in bipolar disorder. Journal of Dual Diagnosis 8, 326332.
Depp, CA, Mausbach, B, Granholm, E, Cardenas, V, Ben-Zeev, D, Patterson, TL, Lebowitz, BD, Jeste, DV (2010). Mobile interventions for severe mental illness: design and preliminary data from three approaches. Journal of Nervous and Mental Disease 198, 715721.
Endler, NS, Parker, JD (1998). Coping Inventory for Stressful Situations (CISS), 2nd edn. Multi-health Systems. Manual.
Faurholt-Jepsen, M, Frost, M, Vinberg, M, Christensen, EM, Bardram, JE, Kessing, LV (2014). Smartphone data as objective measures of bipolar disorder symptoms. Psychiatry Research 217, 124-127.
Faurholt-Jepsen, M, Vinberg, M, Christensen, EM, Frost, M, Bardram, J, Kessing, LV (2013). 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. British Medical Journal Open 3: e003353.
Fava, M, Iosifescu, DV, Pedrelli, P, Baer, L (2009). Reliability and validity of the Massachusetts general hospital cognitive and physical functioning questionnaire. Psychotherapy and Psychosomatics 78, 9197.
Frost, M, Faurholt-Jepsen, M, Doryab, A, Kessing, LV, Bardram, JE (in press). Increasing awareness, insight and adherence in treatment of bipolar disorder through personal health technology: pilot study. Journal of Medical Internet Research.
Ghaemi, SN, Rosenquist, KJ (2004) Is insight in mania state-dependent?: a meta-analysis. Journal of Nervous and Mental Disease 192, 771775.
Guilera, G, Pino, O, Gómez-Benito, J, Rojo, JE, Vieta, E, Tabarés-Seisdedos, R, Segarra, N et al. (2009). Clinical usefulness of the Screen for Cognitive Impairment in Psychiatry (SCIP-S) Scale in patients with type I bipolar disorder. Health and Quality of Life Outcomes 7, 28.
Hamilton, M (1967). Development of a rating scale for primary depressive illness. British Journal of Social and Clinical Psychology 6, 278296.
Henry, C, Van den Bulke, D, Bellivier, F, Roy, I, Swendsen, J, M'Baïlara, K, Siever, LJ, Leboyer, M (2008). Affective lability and affect intensity as core dimensions of bipolar disorders during euthymic period. Psychiatry Research 159, 16.
Husky, MM, Gindre, C, Mazure, CM, Brebant, C, Nolen-Hoeksema, S, Sanacora, G, Swendsen, J (2010). Computerized ambulatory monitoring in mood disorders: feasibility, compliance, and reactivity. Psychiatry Research 178, 440442.
Kessing, LV, Hansen, HV, Hvenegaard, A, Christensen, EM, Dam, H, Gluud, C, Wetterslev, J (2013). Treatment in a specialised out-patient mood disorder clinic v. standard out-patient treatment in the early course of bipolar disorder: randomised clinical trial. British Journal of Psychiatry 202, 212219.
Kessing, LV, Hansen, MG, Andersen, PK (2004). Course of illness in depressive and bipolar disorders. naturalistic study, 1994–1999. British Journal of Psychiatry 185, 372377.
Kessing, LV, Søndergård, L, Kvist, K, Andersen, PK (2007). Adherence to lithium in naturalistic settings: results from a nationwide pharmacoepidemiological study. Bipolar Disorders 9, 730736.
Kreindler, D, Levitt, A, Woolridge, N, Lumsden, CJ (2003). Portable mood mapping: the validity and reliability of analog scale displays for mood assessment via hand-held computer. Psychiatry Research 120, 165177.
Látalová, K (2012). Insight in bipolar disorder. Psychiatric Quarterly 83, 293310.
Laursen, RP, Dalskov, S-M, Damsgaard, CT, Ritz, C (2014). Back-transformation of treatment differences-an approximate method. European Journal of Clinical Nutrition 68, 277280.
Lecrubier, Y, Bech, P (2007). The Ham D(6) is more homogenous and as sensitive as the Ham D(17). European Psychiatry 22, 252255.
Leverich, GS, Nolen, WA, Rush, AJ, McElroy, SL, Keck, PE, Denicoff, KD, Suppes, T, Althuler, LL, Kupka, R, Kramlinger, KG, Post, RM (2001). The Stanley Foundation bipolar treatment outcome network. I. Longitudinal methodology. Journal of Affective Disorders 67, 3344.
Lieberman, DZ, Kelly, TF, Douglas, L, Goodwin, FK (2010). A randomized comparison of online and paper mood charts for people with bipolar disorder. Journal of Affective Disorders 124, 8589.
MacQueen, GM, Marriott, M, Begin, H, Robb, J, Joffe, RT, Young, LT (2003). Subsyndromal symptoms assessed in longitudinal, prospective follow-up of a cohort of patients with bipolar disorder. Bipolar Disorders 5, 349355.
Moher, D, Hopewell, S, Schulz, KF, Montori, V, Gøtzsche, PC, Devereaux, PJ, Elbourne, D, Egger, M, Altman, DG (2010). CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. British Medical Journal (Clinical Research Edition) 340, c869.
Morriss, RK, Faizal, MA, Jones, AP, Williamson, PR, Bolton, C, McCarthy, JP (2007). Interventions for helping people recognise early signs of recurrence in bipolar disorder. Cochrane Database of Systematic Reviews. Art no. CD004854. doi:10.1002/14651858.CD004854.pub2.
National Institute for Clinical Excellence (2004). Depression: Management of Depression in Primary and Secondary Care. National Institute for Clinical Excellence: London, England.
Olsen, LR, Jensen, DV, Noerholm, V, Martiny, K, Bech, P (2003). The internal and external validity of the major depression inventory in measuring severity of depressive states. Psychological Medicine 33, 351356.
Paykel, ES, Abbott, R, Morriss, R, Hayhurst, H, Scott, J (2006). Sub-syndromal and syndromal symptoms in the longitudinal course of bipolar disorder. British Journal of Psychiatry 189, 118123.
Perry, A, Tarrier, N, Morriss, R, McCarthy, E, Limb, K (1999). Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment. British Medical Journal (Clinical Research Edition) 318, 149153.
Rojo, E, Pino, O, Guilera, G, Gómez-Benito, J, Purdon, SE, Crespo-Facorro, B, Cuesta, MJ et al. (2010). Neurocognitive diagnosis and cut-off scores of the Screen for Cognitive Impairment in Psychiatry (SCIP-S). Schizophrenia Research 116, 243251.
Rosa, AR, Sánchez-Moreno, J, Martínez-Aran, A, Salamero, M, Torrent, C, Reinares, M, Comes, M et al. (2007). Validity and reliability of the Functioning Assessment Short Test (FAST) in bipolar disorder. Clinical Practice and Epidemiology in Mental Health: CP & EMH 3, 5.
Sachs, G (2014). Step-BD blank mood chart (http://www.manicdepressive.org/images/samplechart.gif).
Schärer, LO, Hartweg, V, Hoern, M, Graesslin, Y, Strobl, N, Frey, S, Biedermann, C, Walser, S, Walden, J (2002). Electronic diary for bipolar patients. Neuropsychobiology 46 (Suppl. 1), 1012.
Scott, J, Colom, F (2008). Gaps and limitations of psychological interventions for bipolar disorders. Psychotherapy and Psychosomatics 77, 411.
Simon, GE, Ludman, EJ, Bauer, MS, Unützer, J, Operskalski, B (2006). Long-term effectiveness and cost of a systematic care program for bipolar disorder. Archives of General Psychiatry 63, 500508.
Stone, AA, Shiffman, S, Schwartz, JE, Broderick, JE, Hufford, MR (2003). Patient compliance with paper and electronic diaries. Controlled Clinical Trials 24, 182199.
Strejilevich, SA, Martino, DJ, Murru, A, Teitelbaum, J, Fassi, G, Marengo, E, Igoa, A, Colom, F (2013). Mood instability and functional recovery in bipolar disorders. Acta Psychiatrica Scandinavica 128, 194202.
Totterdell, P, Briner, RB, Parkinson, B, Reynolds, S (1996). Fingerprinting time series: dynamic patterns in self-report and performance measures uncovered by a graphical non-linear method. British Journal of Psychology 87, 4360.
WHO (1998). Development of the World Health Organization WHOQOL-BREF Quality of Life Assessment. The WHOQOL Group. Psychological Medicine 28, 551558.
Whybrow, PC, Grof, P, Gyulai, L, Rasgon, N, Glenn, T, Bauer, M (2003). The electronic assessment of the longitudinal course of bipolar disorder: The ChronoRecord Software. Pharmacopsychiatry 36 (Suppl. 3), S244S249.
Wing, JK, Babor, T, Brugha, T, Burke, J, Cooper, JE, Giel, R, Jablenski, A, Regier, D, Sartorius, N (1990). SCAN. Schedules for Clinical Assessment in Neuropsychiatry. Archives of General Psychiatry 47, 589593.
Yen, C-F, Chen, C-S, Ko, C-H, Yen, J-Y, Huang, C-F (2007). Changes in insight among patients with bipolar I disorder: a 2-year prospective study. Bipolar Disorders 9, 238242.
Young, RC, Biggs, JT, Ziegler, VE, Meyer, DA (1978). A rating scale for mania: reliability, validity and sensitivity. British Journal of Psychiatry 133, 429435.

Keywords

Metrics

Altmetric attention score

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed