Skip to main content Accessibility help

The effect of smartphone-based monitoring on illness activity in bipolar disorder: the MONARCA II randomized controlled single-blinded trial

  • Maria Faurholt-Jepsen (a1), Mads Frost (a2), Ellen Margrethe Christensen (a1), Jakob E. Bardram (a3), Maj Vinberg (a1) and Lars Vedel Kessing (a1)...



Recently, the MONARCA I randomized controlled trial (RCT) was the first to investigate the effect of smartphone-based monitoring in bipolar disorder (BD). Findings suggested that smartphone-based monitoring sustained depressive but reduced manic symptoms. The present RCT investigated the effect of a new smartphone-based system on the severity of depressive and manic symptoms in BD.


Randomized controlled single-blind parallel-group trial. Patients with BD, previously treated at The Copenhagen Clinic for Affective Disorder, Denmark and currently treated at community psychiatric centres, private psychiatrists or GPs were randomized to the use of a smartphone-based system or to standard treatment for 9 months. Primary outcomes: differences in depressive and manic symptoms between the groups.


A total of 129 patients with BD (ICD-10) were included. Intention-to-treat analyses showed no statistically significant effect of smartphone-based monitoring on depressive (B = 0.61, 95% CI −0.77 to 2.00, p = 0.38) and manic (B = −0.25, 95% CI −1.1 to 0.59, p = 0.56) symptoms. The intervention group reported higher quality of life and lower perceived stress compared with the control group. In sub-analyses, the intervention group had higher risk of depressive episodes, but lower risk of manic episodes compared with the control group.


There was no effect of smartphone-based monitoring. In patient-reported outcomes, patients in the intervention group reported improved quality of life and reduced perceived stress. Patients in the intervention group had higher risk of depressive episodes and reduced risk of manic episodes. Despite the widespread use and excitement of electronic monitoring, few studies have investigated possible effects. Further studies are needed.


Corresponding author

Author for correspondence: Maria Faurholt-Jepsen, E-mail:


Hide All
Adli, M, Whybrow, PC, Grof, P, Rasgon, N, Gyulai, L, Baethge, C, Glenn, T and Bauer, M (2005) Use of polypharmacy and self-reported mood in outpatients with bipolar disorder. International Journal of Psychiatry in Clinical Practice 4, 251256.
Altman, EG, Hedeker, D, Peterson, JL and Davis, JM (1997) The Altman Self-Rating Mania Scale. Biological Psychiatry 42, 948955.
Angst, J and Sellaro, R (2000) Historical perspectives and natural history of bipolar disorder. Biological Psychiatry 48, 445457.
Anthes, E (2016) Mental health: there's an app for that. Nature 532, 2023.
Bardram, J, Frost, M, Szanto, K and Margu, G (2012) The MONARCA self-assessment system: a persuasive personal monitoring system for bipolar patients. In Proceedings of the 2nd ACM SIGHIT International Health Informatics Symposium (IHI ’12). ACM, New York, NY, USA, 21–30. vol 2012, pp 21–30. ACM New York, NY, USA.
Bardram, JE, Frost, M, Szánto, K, Faurholt-Jepsen, M, Vinberg, M and 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, pp2627-2636. New York, NY, USA, 2013.
Barnes, CW, Hadzi-Pavlovic, D, Wilhelm, K and Mitchell, PB (2015) A web-based preventive intervention program for bipolar disorder: outcome of a 12-months randomized controlled trial. Journal of Affective Disorders 174, 485492.
Bauer, M, Grof, P, Gyulai, L, Rasgon, N, Glenn, T and Whybrow, PC (2004) Using technology to improve longitudinal studies: self-reporting with ChronoRecord in bipolar disorder. Bipolar Disorders 6, 6774.
Bauer, M, Rasgon, N, Grof, P, Gyulai, L, Glenn, T and Whybrow, PC (2005) Does the use of an automated tool for self-reporting mood by patients with bipolar disorder bias the collected data? MedGenMed: Medscape General Medicine 7, 21.
Bauer, M, Grof, P, Rasgon, N, Glenn, T, Alda, M, Priebe, S, Ricken, R and Whybrow, PC (2006) Mood charting and technology: new approach to monitoring patients with mood disorders. Current Psychiatry Reviews 2, 423429.
Bauer, M, Glenn, T, Grof, P, Pfennig, A, Rasgon, NL, Marsh, W, Munoz, RA, Sagduyu, K, Alda, M, Quiroz, D, Sasse, J and Whybrow, PC (2007) Self-reported data from patients with bipolar disorder: frequency of brief depression. Journal of Affective Disorders 101, 227233.
Bauer, M, Wilson, T, Neuhaus, K, Sasse, J, Pfennig, A, Lewitzka, U, Grof, P, Glenn, T, Rasgon, N, Bschor, T and Whybrow, PC (2008) Self-reporting software for bipolar disorder: validation of ChronoRecord by patients with mania. Psychiatry Research 159, 359366.
Bech, P, Rasmussen, NA, Olsen, LR, Noerholm, V and 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.
Ben-Zeev, D, Brian, RM, Jonathan, G, Razzano, L, Pashka, N, Carpenter-Song, E, Drake, RE and Scherer, EA (2018) Mobile health (mHealth) versus clinic-based group intervention for people with serious mental illness: a randomized controlled trial. Psychiatric Services 69, 978985.
Bilderbeck, AC, Atkinson, LZ, McMahon, HC, Voysey, M, Simon, J, Price, J, Rendell, J, Hinds, C, Geddes, JR, Holmes, E, Miklowitz, DJ and Goodwin, GM (2016) Psychoeducation and online mood tracking for patients with bipolar disorder: a randomised controlled trial. Journal of Affective Disorders 205, 245251.
Bopp, JM, Miklowitz, DJ, Goodwin, GM, Stevens, W, Rendell, JM and 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 and Ravaud, P (2008) Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Annals of Internal Medicine 148, 295309.
Chan, A-W, Tetzlaff, JM, Altman, DG, Dickersin, K and Moher, D (2013) SPIRIT 2013: new guidance for content of clinical trial protocols. Lancet 381, 9192.
Chinman, M, Young, AS, Schell, T, Hassell, J and Mintz, J (2004) Computer-assisted self-assessment in persons with severe mental illness. The Journal of Clinical Psychiatry 65, 13431351.
Cohen, S, Kamarck, T and Mermelstein, R (1983) A global measure of perceived stress. Journal of Health and Social Behavior 24, 385396.
Corrigan, PW, Salzer, M, Ralph, RO, Sangster, Y and Keck, L (2004) Examining the factor structure of the recovery assessment scale. Schizophrenia Bulletin 30, 10351041.
Depp, CA, Mausbach, B, Granholm, E, Cardenas, V, Ben-Zeev, D, Patterson, TL, Lebowitz, BD and Jeste, DV (2010) Mobile interventions for severe mental illness: design and preliminary data from three approaches. The Journal of Nervous and Mental Disease 198, 715721.
Depp, CA, Kim, DH, de Dios, LV, Wang, V and 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, Ceglowski, J, Wang, VC, Yaghouti, F, Mausbach, BT, Thompson, WK and Granholm, EL (2015) Augmenting psychoeducation with a mobile intervention for bipolar disorder: a randomized controlled trial. Journal of Affective Disorders 174, 2330.
Donker, T, Petrie, K, Proudfoot, J, Clarke, J, Birch, M-R and Christensen, H (2013) Smartphones for smarter delivery of mental health programs: a systematic review. Journal of Medical Internet Research 15, e247.
Faurholt-Jepsen, M, Brage, S, Vinberg, M, Christensen, EM, Knorr, U, Jensen, HM and Kessing, LV (2012) Differences in psychomotor activity in patients suffering from unipolar and bipolar affective disorder in the remitted or mild/moderate depressive state. Journal of Affective Disorders 141, 457463.
Faurholt-Jepsen, M, Vinberg, M, Christensen, EM, Frost, M, Bardram, J and 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. BMJ Open 3, 7.
Faurholt-Jepsen, M, Frost, M, Vinberg, M, Christensen, EM, Bardram, JE and Kessing, LV (2014 a) Smartphone data as objective measures of bipolar disorder symptoms. Psychiatry Research 217, 12.
Faurholt-Jepsen, M, Vinberg, M, Frost, M, Christensen, EM, Bardram, J and Kessing, LV (2014 b) 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 14, 309.
Faurholt-Jepsen, M, Frost, M, Ritz, C, Christensen, EM, Jacoby, AS, Mikkelsen, RL, Knorr, U, Bardram, JE, Vinberg, M and Kessing, LV (2015 a) Daily electronic self-monitoring in bipolar disorder using smartphones – the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial. Psychological Medicine 45, 26912704.
Faurholt-Jepsen, M, Vinberg, M, Frost, M, Christensen, EM, Bardram, JE and Kessing, LV (2015 b) Smartphone data as an electronic biomarker of illness activity in bipolar disorder. Bipolar Disorders 17, 715728.
Faurholt-Jepsen, M, Busk, J, Frost, M, Vinberg, M, Christensen, EM, Winther, O, Bardram, JE and Kessing, LV (2016 a) Voice analysis as an objective state marker in bipolar disorder. Translational Psychiatry 6, e856.
Faurholt-Jepsen, M, Munkholm, K, Frost, M, Bardram, JE and Kessing, LV (2016 b) Electronic self-monitoring of mood using IT platforms in adult patients with bipolar disorder: a systematic review of the validity and evidence. BMC Psychiatry 16, 7.
Faurholt-Jepsen, M, Vinberg, M, Frost, M, Debel, S, Margrethe Christensen, E, Bardram, JE and Kessing, LV (2016 c) Behavioral activities collected through smartphones and the association with illness activity in bipolar disorder. International Journal of Methods in Psychiatric Research 25, 309323.
Faurholt-Jepsen, M, Frost, M, Martiny, K, Tuxen, N, Rosenberg, N, Busk, J, Winther, O, Bardram, JE and Kessing, LV (2017) Reducing the rate and duration of Re-ADMISsions among patients with unipolar disorder and bipolar disorder using smartphone-based monitoring and treatment – the RADMIS trials: study protocol for two randomized controlled trials. Trials 18, 277.
Faurholt-Jepsen, M, Busk, J, Þórarinsdóttir, H, Frost, M, Bardram, JE, Vinberg, M and Kessing, LV (2018) Objective smartphone data as a potential diagnostic marker of bipolar disorder. Australian & New Zealand Journal of Psychiatry 53, 119128.
FierceWireless (2011) Report: Global smartphone penetration to jump 25% in 2014, led by Asia-Pacific. FierceWireless.
Furukawa, TA, Horikoshi, M, Fujita, H, Tsujino, N, Jinnin, R, Kako, Y, Ogawa, S, Sato, H, Kitagawa, N, Shinagawa, Y, Ikeda, Y, Imai, H, Tajika, A, Ogawa, Y, Akechi, T, Yamada, M, Shimodera, S, Watanabe, N, Inagaki, M and Hasegawa, A (2018) Cognitive and behavioral skills exercises completed by patients with major depression during smartphone cognitive behavioral therapy: secondary analysis of a randomized controlled trial. JMIR Mental Health 5, e4.
Hamilton, M (1967) Development of a rating scale for primary depressive illness. The British Journal of Social and Clinical Psychology 6, 278296.
Harrison, PJ, Cipriani, A, Harmer, CJ, Nobre, AC, Saunders, K, Goodwin, GM and Geddes, JR (2016) Innovative approaches to bipolar disorder and its treatment. Annals of the New York Academy of Sciences 1366, 7689.
Hidalgo-Mazzei, D, Mateu, A, Reinares, M, Undurraga, J, Bonnín Cdel, M, Sánchez-Moreno, J, Vieta, E and Colom, F (2015) Self-monitoring and psychoeducation in bipolar patients with a smart-phone application (SIMPLe) project: design, development and studies protocols. BMC Psychiatry 15, 52.
Insel, TR (2017) Digital phenotyping: technology for a new science of behavior. JAMA 318, 12151216.
Judd, LL, Schettler, PJ, Akiskal, HS, Maser, J, Coryell, W, Solomon, D, Endicott, J and Keller, M (2003) Long-term symptomatic status of bipolar I vs. bipolar II disorders. The International Journal of Neuropsychopharmacology 6, 127137.
Kessing, LV, Hansen, MG and Andersen, PK (2004) Course of illness in depressive and bipolar disorders. Naturalistic study, 1994–1999. The British Journal of Psychiatry 185, 372377.
Kessing, LV, Hansen, HV, Hvenegaard, A, Christensen, EM, Dam, H, Gluud, C and 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. The British Journal of Psychiatry 202, 212219.
Krzystanek, M, Borkowski, M, Skałacka, K and Krysta, K (2018) A telemedicine platform to improve clinical parameters in paranoid schizophrenia patients: results of a one-year randomized study. Schizophrenia Research 204, 389396.
Kuhs, H and Reschke, D (1992) Psychomotor activity in unipolar and bipolar depressive patients. Psychopathology 25, 109116.
Kupfer, DJ, Weiss, BL, Foster, G, Detre, TP and McPartland, R (1974) Psychomotor activity in affective states. Archives of General Psychiatry 30, 765768.
Lauder, S, Chester, A, Castle, D, Dodd, S, Gliddon, E, Berk, L, Chamberlain, J, Klein, B, Gilbert, M, Austin, DW and Berk, M (2015) A randomized head to head trial of an Internet based self-help program for bipolar disorder. Journal of Affective Disorders 171, 1321.
Lieberman, DZ, Kelly, TF, Douglas, L and Goodwin, FK (2010) A randomized comparison of online and paper mood charts for people with bipolar disorder. Journal of Affective Disorders 124, 8589.
Lieberman, DZ, Swayze, S and Goodwin, FK (2011) An automated Internet application to help patients with bipolar disorder track social rhythm stabilization. Psychiatric Services 62, 12671269.
Moher, D, Hopewell, S, Schulz, KF, Montori, V, Gøtzsche, PC, Devereaux, PJ, Elbourne, D, Egger, M and Altman, DG (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ (Clinical Research ed.) 340, c869.
Mühlbauer, E, Bauer, M, Ebner-Priemer, U, Ritter, P, Hill, H, Beier, F, Kleindienst, N and Severus, E (2018) Effectiveness of smartphone-based ambulatory assessment (SBAA-BD) including a predicting system for upcoming episodes in the long-term treatment of patients with bipolar disorders: study protocol for a randomized controlled single-blind trial. BMC Psychiatry 18, 349.
Musiat, P, Goldstone, P and Tarrier, N (2014) Understanding the acceptability of e-mental health – attitudes and expectations towards computerised self-help treatments for mental health problems. BMC Psychiatry 14, 109.
Mutschler, J, von Zitzewitz, F, Rossler, W and Grosshans, M (2012) Application of electronic diaries in patients with schizophrenia and bipolar disorders. Psychiatria Danubina 24, 206210.
O'Donnell, LA, Ellis, AJ, de Loo, MMV, Stange, JP, Axelson, DA, Kowatch, RA, Schneck, CD and Miklowitz, DJ (2018) Mood instability as a predictor of clinical and functional outcomes in adolescents with bipolar I and bipolar II disorder. Journal of Affective Disorders 236, 1992206.
Patel, R, Lloyd, T, Jackson, R, Ball, M, Shetty, H, Broadbent, M, Geddes, JR, Stewart, R, McGuire, P and Taylor, M (2015) Mood instability is a common feature of mental health disorders and is associated with poor clinical outcomes. BMJ Open 5, e007504.
Perry, A, Tarrier, N, Morriss, R, McCarthy, E and Limb, K (1999) Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment. BMJ (Clinical Research ed.) 318, 149153.
Pini, S, de Queiroz, V, Pagnin, D, Pezawas, L, Angst, J, Cassano, GB and Wittchen, H-U (2005) Prevalence and burden of bipolar disorders in European countries. European Neuropsychopharmacology 15, 425434.
Rogers, ES, Chamberlin, J, Ellison, ML and Crean, T (1997) A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatric Services 48, 10421047.
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 and Vieta, E (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.
Saunders, KEA, Cipriani, A, Rendell, J, Attenburrow, M-J, Nelissen, N, Bilderbeck, AC, Vasudevan, SR, Churchill, G, Goodwin, GM, Nobre, AC, Harmer, CJ, Harrison, PJ and Geddes, JR (2016) Oxford lithium Trial (OxLith) of the early affective, cognitive, neural and biochemical effects of lithium carbonate in bipolar disorder: study protocol for a randomised controlled trial. Trials 17.
Simon, GE, Ludman, EJ, Bauer, MS, Unützer, J and Operskalski, B (2006) Long-term effectiveness and cost of a systematic care program for bipolar disorder. Archives of General Psychiatry 63, 500508.
Stolz, T, Schulz, A, Krieger, T, Vincent, A, Urech, A, Moser, C, Westermann, S and Berger, T (2018) A mobile app for social anxiety disorder: a three-arm randomized controlled trial comparing mobile and PC-based guided self-help interventions. Journal of Consulting and Clinical Psychology 86, 493504.
Strejilevich, SA, Martino, DJ, Murru, A, Teitelbaum, J, Fassi, G, Marengo, E, Igoa, A and Colom, F (2013) Mood instability and functional recovery in bipolar disorders. Acta Psychiatrica Scandinavica 128, 194202.
Thompson, K, Kulkarni, J and Sergejew, AA (2000) Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research 42, 241247.
Todd, NJ, Jones, SH, Hart, A and Lobban, FA (2014) A web-based self-management intervention for bipolar disorder ‘living with bipolar’: a feasibility randomised controlled trial. Journal of Affective Disorders 169, 2129.
Wang, K, Varma, DS and Prosperi, M (2018) A systematic review of the effectiveness of mobile apps for monitoring and management of mental health symptoms or disorders. Journal of Psychiatric Research 107, 7378.
Weinstock, LM and Miller, IW (2008) Functional impairment as a predictor of short-term symptom course in bipolar I disorder. Bipolar Disorders 10, 437442.
WHO (1998) Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychological Medicine 28, 551558.
WHO (2011) mHealth: New Horizons for Health Through Mobile Technologies. Geneva: WHO. Available at
Whybrow, PC, Grof, P, Gyulai, L, Rasgon, N, Glenn, T and 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 and Sartorius, N (1990) SCAN. Schedules for Clinical Assessment in Neuropsychiatry. Archives of General Psychiatry 47, 589593.
World Health Organisation W (2011) ICD-10: International Statistical Classification of Diseases and Related Health Problems, vol 2011. Geneva: World Health Organization.
Young, RC, Biggs, JT, Ziegler, VE and Meyer, DA (1978) A rating scale for mania: reliability, validity and sensitivity. The British Journal of Psychiatry 133, 429435.


Type Description Title
Supplementary materials

Faurholt-Jepsen et al. supplementary material
Faurholt-Jepsen et al. supplementary material 1

 Word (20 KB)
20 KB


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