ChronoRecord Background

Mood disorders are mental illnesses in which a person experiences emotions outside the normal boundaries of sadness and elation.¹ The most commonly occurring mood disorder is major depressive disorder, which features one or more episodes of depression.² Bipolar disorder features one or more episodes of mania or episodes of both mania and depression. Other mood disorders are dysthymia (persistent low-grade depression) and cyclothymia (mild moodswings).

Mood disorders are prevalent and despite current treatments, episodes recur frequently. In the US, the National Comorbidity Study showed a lifetime prevalence of 17% for major depressive disorder and 1.6% for bipolar disorder.³ Mood disorders are associated with high morbidity and mortality. Following an initial episode, the probability of recurrence in major depressive disorder is 50-85%.⁴ In bipolar disorder, the probability of recurrence within 5 years is 90%.⁵ Dysthymia is associated with a marked increase in risk of developing major depressive episodes.⁶

Many patients do not obtain full recovery between episodes. In 20-30% of those with major depressive disorder, the depressive symptoms persist for longer than a year after treatment of the acute phase and 12% do not recover within 5 years.⁷ In bipolar disorder, episodes of mania and depression are often protracted with 24% of patients remaining acutely ill after 1 year, 16% after 2 years and 9% after 5 years.⁸ Many patients with depressive disorder or bipolar disorder report residual symptoms that impose considerable morbidity despite treatment.⁹ As a consequence, many patients with bipolar disorder¹⁰ and major depressive disorder¹¹ will develop a chronic and disabling course. Both major depressive disorder and bipolar disorder are among the top 10 causes of worldwide disability.¹²

The treatment of mood disorders is complex and usually requires a patient to take multiple medications several times a day. Maintenance therapy to prevent a recurrence of major depressive disorder may last several years or more¹³ while maintenance therapy for bipolar disorder is usually for the patient’s lifetime.¹⁴

Most medications that are used to treat psychiatric disorders have uncomfortable side effects such as weight gain, tremors, hair loss and cognitive dulling.¹⁵ Although the combinations of drugs needed to treat mood disorders may improve response, they also increase side effects and patient costs. Polypharmacy schedules can be difficult to adhere to. Thus, an understanding of the disorder and long-term commitment to the treatment is needed from the patient. Patient non-compliance with medication is a serious problem and the major factor that accounts for patient relapse. Studies show that between 24-53% of patients with major depressive or bipolar disorder are non-compliant with maintenance therapy.^16,17,18,19

Patient Self-Reporting

Daily patient self-reporting of mood and sleep is well established as a valuable clinical tool and has many benefits for both the patient and the practitioner.²⁰^,²¹ Mood disorders are characterized by rapid changes in mood that make treatment decisions difficult. The prospective semi-continuous measure of fluctuations of patients’ mood and sleep allows for detailed assessment of frequency and pattern of illness.²² Simultaneous comparison of daily mood fluctuations and medications may help to optimize and rationalize complex pharmacological therapy and to better detect nuances of partial response.²³ Another benefit of daily self-reporting of mood is increased patient involvement in their care.

Three methodologies are commonly used for daily patient self-reporting of mood: the Life Chart Methodology,²¹ the STEP-BP Mood Chart²⁴ and the ChronoSheet. The latter uses a 100-mm visual analogue scale (VAS) between the extreme states of mania and depression that the patient marks proportionately.²⁰ The patient describes all predominant features of the extreme state in addition to mood to set the anchor point. The ChronoSheet also records sleep, weight, psychiatric medications and life events. These self-rating methodologies are all paper and pencil based. The patient is given a form or booklet to complete by hand daily. The patient returns the completed form to staff monthly for data entry into a computer for analysis. There are several problems with a paper-based process. Patients complete paper forms sporadically,²⁵ often just before a clinic visit when recall may be biased.²⁶ Overall data quality is negatively impacted by data entry errors. The VAS data requires a manual digitization for computer entry. Any data transformations performed by humans provide additional opportunities for error.

ChronoRecord overcomes these deficiencies and allows the patient to enter daily mood ratings directly into a home computer. It is easy and fast for patients to use daily. An automated charting system may be perceived by the patient as more convenient to complete that a paper-pencil system thus improving compliance. Patients can click a mouse and send their data to the doctor for immediate analysis.

References

¹ Whybrow, PC. A Mood Apart. New York: HarperCollins Publishers, Inc. 1997.

² American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th revision (DSM-IV). Washington: American Psychiatric Press, 1994a.

³ Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry 1994;51:8-19.

⁴ Mueller TI, Leon AC, Keller MB, Solomon DA, Endicott J, Coryell W, Warshaw M, Maser JD. Recurrence after recovery from major depressive disorder during 15 years of observational follow-up. Am J Psychiatry 1999; 156(7):1000-6.

⁵ Tohen M, Waternaux CS, Tsuang MT. Outcome in Mania: A 4-year prospective followup of 75 patients utilizing survival analysis. Arch Gen Psychiatry. 1990;47:1106-1111.

⁶ Keller MB, Shapiro RW. “Double depression”: superimposition of acute depressive episodes on chronic depressive disorders. Am J Psychiatry 1982;139:438-42.

⁷ Keller MB, Lavori PW, Mueller TI, Endicott J, Coryell W, Hirshfield RM, Shea T. Time to Recovery, chronicity, and levels of psychopathology in major depression. A 5-year prospective follow-up of 431 subjects. Arch Gen Psychiatry 1992;49:809-16.

⁸ Keller MB, Lavori PW, Coryell W, Endicott J, Mueller TI. Bipolar I: A five-year prospective follow-up. J Nerv Ment Dis 1993;181:238-45.

⁹ Fava GA. Subclinical symptoms in mood disorders: Pathophysiological and therapeutic implications. Psychol Med 1999;29:47-61.

¹⁰ Gitlin MJ, Swendsen J, Heller TL, Hammen C. Relapse and impairment in bipolar disorder. Am J Psychiatry 1995;152:1635-40.

¹¹ Thase, M. E., & Sullivan, L. R. (1995). Relapse and recurrence of depression: A practical approach for prevention. CNS Drugs, 4, 261–277.

¹² Murray CJ, Lopez AD. Evidence-based health policy--lessons from the Global Burden of Disease Study. Science 1996;274:1593-4.

¹³ Bauer M, Whybrow PC, Angst J, Versiani M, Möller HJ. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for biological treatment of unipolar depressive disorders. Part 2. Maintenance treatment of major depressive disorder and treatment of chronic depressive disorders and subthreshold depressions. World J Biol Psychiatr 2002; 3:67-84.

¹⁴ Müller-Oerlinghausen B, Berghöfer A, Bauer M. Bipolar disorder. Lancet 2002;359:241-247.

¹⁵ Bauer M, Whybrow PC, Angst J, Versiani M, Möller HJ. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for biological treatment of unipolar depressive disorders. Part 1. Acute and continuation treatment of major depressive disorder. World J Biol Psychiatr 2002;3:5-43.

¹⁶ Schumann C, Lenz G, Berghöfer A, Müller-Oerlinghausen B. Non-adherence with long-term prophylaxis: A 6-year naturalistic follow-up study of affectively ill patients. Psychiatry Res 1999;89:247-57.

¹⁷ Simon SE, VonKorff M, Wagner EH, Barlow W. Patterns of antidepressant use in community practice. Gen Hops Psychiatry 1993;15:399-408.

¹⁸ Aagaard J, Vestergaard P, Maargjerg K. Adherence to lithium prophylaxis: I. Clinical predictors and patient’s reasons for nonadherence. Pharmacopsychiatry 1988;21:121-125.

¹⁹ Berghöfer A, Kossmann B, Müller-Oerlinghausen B. Course of illness and pattern of recurrences in patients with affective disorders during long-term lithium prophylaxis: a retrospective analysis over 15 years. Acta Psychiatr Scand 1996;93:349-54.

²⁰ 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. Arch Gen Psychiatry 48:807-812.

²¹ Leverich GS, Post RM (1996). Life charting the course of bipolar disorder. Curr Rev Mood Anxiety Disord 1:48-61.

²² Denicoff KD, Smith-Jackson EE, Disney ER, Suddath RL, Leverich GS, Post RM (1997). Preliminary evidence of the reliability and validity of the prospective life-chart methodology (LCM-p). J Psychiatr Res 31:593-603.

²³ Post RM, Leverich GS, Denicoff KD, Frye MA, Kimbrell TA, Dunn R (1997). Alternative approaches to refractory depression in bipolar illness. Depression Anxiety 5:175-189.

²⁴ Sachs, G Step-BP Blank Mood Chart, Available at www.manicdepressive.org/images/samplechart.gif. Accessed on 6/1/2003.

²⁵ 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;36:1-6.

²⁶ Kobak KA, Greist JH, Jefferson JW, Katzelnick DJ, Mundt JC. New technologies to improve clinical trials. J Clin Psychopharmacol 2001; 21: 255-256.