Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial. Voice analysis as an objective state marker in bipolar disorder 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 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 A Pilot Study of Mood Ratings Captured by Mobile Phone Versus Paper-and-Pencil Mood Charts in Bipolar Disorder Using Smartphones to Monitor Bipolar Disorder Symptoms: A Pilot Study Saving time and money: a validation of the self ratings on the prospective NIMH life-chart method (NIMH-LCM) Augmenting psychoeducation with a mobile intervention for bipolar disorder: a randomized controlled trial. Self-monitoring and psychoeducation in bipolar patients with a smart-phone application (SIMPLe) project: design, development and studies protocols Long-term effectiveness and cost of a systematic care program for bipolar disorder. Effectiveness of adjunctive antidepressant treatment for bipolar depression. Self-monitoring Using Mobile Phones in the Early Stages of Adolescent Depression: Randomized Controlled Trial Adherence to antihypertensive medication assessed by self-report was associated with electronic monitoring compliance. Design and implementation of a randomized trial evaluating systematic care for bipolar disorder. A prospective, longitudinal study of percentage of time spent ill in patients with bipolar I or bipolar II disorders. An open-label trial of aripiprazole monotherapy in children and adolescents with bipolar disorder. A Prospective Open‐Label Trial of Lamotrigine Monotherapy in Children and Adolescents with Bipolar Disorder Quetiapine for the continuation treatment of bipolar depression: naturalistic prospective case series from the Stanley Bipolar Treatment Network The HCL-32: towards a self-assessment tool for hypomanic symptoms in outpatients. Validation of the prospective NIMH-Life-Chart Method (NIMH-LCM-p) for longitudinal assessment of bipolar illness. Randomized trial of a population-based care program for people with bipolar disorder. A measure for assessing patient perception of provider support for self-management of bipolar disorder. A randomized comparison of online and paper mood charts for people with bipolar disorder.
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 r and omized 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 r and omized 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 purpose s ( 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 Changes in speech have been suggested as sensitive and valid measures of depression and mania in bipolar disorder . The present study aim ed at investigating ( 1 ) voice features collected during phone calls as objective markers of affective states in bipolar disorder and ( 2 ) if combining voice features with automatically generated objective smartphone data on behavioral activities ( for example , number of text messages and phone calls per day ) and  electronic self-monitored data ( mood ) on illness activity would increase the accuracy as a marker of affective states . Using smartphones , voice features , automatically generated objective smartphone data on behavioral activities  and  electronic self-monitored data  were collected from 28 out patients with bipolar disorder in naturalistic setting s on a daily basis during a period of 12 weeks . Depressive and manic symptoms were assessed using the Hamilton Depression Rating Scale 17-item and the Young Mania Rating Scale , respectively , by a research er blinded to smartphone data . Data were analyzed using r and om forest algorithms . Affective states were classified using voice features extracted during everyday life phone calls . Voice features were found to be more accurate , sensitive and specific in the classification of manic or mixed states with an area under the curve (AUC)=0.89 compared with an AUC=0.78 for the classification of depressive states . Combining voice features with automatically generated objective smartphone data on behavioral activities  and electronic self-monitored data  increased the accuracy , sensitivity and specificity of classification of affective states slightly . Voice features collected in naturalistic setting s using smartphones may be used as objective state markers in patients with bipolar disorder 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 r and omized 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 purpose s , 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 r and omized 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 r and omized 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 purpose s ( 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 Clinical Trials.gov NCT02221336 . Registered 26th of September 2014 Introduction Electronic self-monitoring of affective symptoms using cell phones is suggested as a practical and inexpensive way to monitor illness activity and identify early signs of affective symptoms . It has never been tested in a r and omised clinical trial whether electronic self-monitoring improves outcomes in bipolar disorder . We are conducting a trial testing the effect of using a Smartphone for self-monitoring in bipolar disorder . Methods We developed the MONARCA application for And roid-based Smartphones , allowing patients suffering from bipolar disorder to do daily self-monitoring — including an interactive feedback loop between patients and clinicians through a web-based interface . The effect of the application was tested in a parallel-group , single-blind r and omised controlled trial so far including 78 patients suffering from bipolar disorder in the age group 18–60 years who were given the use of a Smartphone with the MONARCA application ( intervention group ) or to the use of a cell phone without the application ( placebo group ) during a 6-month study period . The study was carried out from September 2011 . The outcomes were changes in affective symptoms ( primary ) , social functioning , perceived stress , self-rated depressive and manic symptoms , quality of life , adherence to medication , stress and cognitive functioning ( secondary and tertiary ) . Analysis Recruitment is ongoing . Ethics Ethical permission has been obtained . Dissemination Positive , neutral and negative findings of the study will be published . Registration details The trial is approved by the Regional Ethics Committee in The Capital Region of Denmark ( H-2 - 2011 - 056 ) and The Danish Data Protection Agency ( 2013 - 41 - 1710 ) . The trial is registered at Clinical Trials.gov as NCT01446406 Objective : Patient-reported mood charts are frequently used in management of bipolar disorder . Although mood charts have recently been programmed in electronic devices such as mobile phones , little is known about the impact of the method of data capture on the psychometric properties and validity of these data . Methods : In an ongoing pilot study , a sample of out patients with bipolar disorder were r and omized to complete mood charts either on a mobile phone or with st and ard paper and pencil as part of a 12-week intervention ( primary outcomes for the trial await study completion ) . We compared these conditions across a single item rating of mood state , and we hypothesized that mobile phone-based data capture would produce greater compliance to mood ratings , variability between and within participants , and concurrent validity with blinded clinician-rated affective symptom severity . Results : A total of 56 participants were r and omized and 40 participants were included in the analyses . There were no significant differences between conditions on demographic or clinical variables . The rate of compliance was significantly higher in paper- and -pencil versus mobile phone ratings . Ratings demonstrated significantly more variability within individuals in the mobile phone condition . Mobile phone mood ratings were significantly correlated with clinician-rated depressive symptom severity across the study and with manic symptom severity at the week-6 assessment , whereas paper- and -pencil ratings were not significantly associated with clinician-rated depression or mania . Conclusions : Although preliminary , our results suggest a lower rate of compliance with mobile phones compared to paper- and -pencil daily mood rating in bipolar disorder , yet a greater ability to capture variability and concurrent validity in quantifying affective symptoms . This clinical trial is registered at www . clinical trials.gov as NCT01670123 Background Relapse prevention in bipolar disorder can be improved by monitoring symptoms in patients ' daily life .  Smartphone apps are easy-to-use , low-cost tools that can be used to assess this information . To date , few studies have examined the usefulness of smartphone data for monitoring symptoms in bipolar disorder . Objective We present results from a pilot test of a smartphone-based monitoring system , Social Information Monitoring for Patients with Bipolar Affective Disorder ( SIMBA ) , that tracked daily mood , physical activity , and social communication in 13 patients . The objective of this study was to investigate whether smartphone measurements predicted clinical symptoms levels and clinical symptom change . The hypotheses that smartphone measurements are ( 1 ) negatively related to clinical depressive symptoms and ( 2 ) positively related to clinical manic symptoms were tested . Methods Clinical rating scales were administered to assess clinical depressive and manic symptoms . Patients used a smartphone with the monitoring app for up to 12 months . R and om-coefficient multilevel models were computed to analyze the relationship between smartphone data and externally rated manic and depressive symptoms . Overall clinical symptom levels and clinical symptom changes were predicted by separating between-patient and within-patient effects . Using established clinical thresholds from the literature , marginal effect plots displayed clinical relevance of smartphone data . Results Overall symptom levels and change in clinical symptoms were related to smartphone measures . Higher overall levels of clinical depressive symptoms were predicted by lower self-reported mood measured by the smartphone ( beta=-.56 , P<.001 ) . An increase in clinical depressive symptoms was predicted by a decline in social communication ( ie , outgoing text messages : beta=-.28 , P<.001 ) and a decline in physical activity as measured by the smartphone ( ie , cell tower movements : beta=-.11 , P=.03 ) . Higher overall levels of clinical manic symptoms were predicted by lower physical activity on the smartphone ( ie , distance travelled : beta=-.37 , P<.001 ) , and higher social communication ( beta=.48 , P=.03 ) . An increase in clinical manic symptoms was predicted by a decrease in physical activity on the smartphone ( beta=-.17 , P<.001 ) . Conclusions Clinical symptoms were related to some objective and subjective smartphone measurements , but not all smartphone measures predicted the occurrence of bipolar symptoms above clinical thresholds . Thus , smartphones have the potential to monitor bipolar disorder symptoms in patients ’ daily life . Further validation of monitoring tools in a larger sample is needed . Conclusions are limited by the low prevalence of manic and depressive symptoms in the study sample . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 05663421 ; http://www.controlled-trials.com/IS RCT N05663421 ( Archived by WebCite at http://www.webcitation.org/6d9wsibJB Background Careful observation of the longitudinal course of bipolar disorders is pivotal to finding optimal treatments and improving outcome . A useful tool is the daily prospect i ve Life-Chart Method , developed by the National Institute of Mental Health . However , it remains unclear whether the patient version is as valid as the clinician version . Methods We compared the patient-rated version of the Lifechart ( LC-self ) with the Young-Mania-Rating Scale ( YMRS ) , Inventory of Depressive Symptoms – Clinician version ( IDS-C ) , and Clinical Global Impression – Bipolar version ( CGI-BP ) in 108 bipolar I and II patients who participated in the Naturalistic Follow-up Study ( NFS ) of the German centres of the Bipolar Collaborative Network ( BCN ; formerly Stanley Foundation Bipolar Network ) . For statistical evaluation , levels of severity of mood states on the Lifechart were transformed numerically and comparison with affective scales was performed using chi-square and t tests . For testing correlations Pearson´s coefficient was calculated . Results Ratings for depression of LC-self and total scores of IDS-C were found to be highly correlated ( Pearson coefficient r = −.718 ; p < .001 ) , whilst the correlation of ratings for mania with YMRS compared to LC-self were slightly less robust ( Pearson coefficient r = .491 ; p = .001 ) . These results were confirmed by good correlations between the CGI-BP IA ( mania ) , IB ( depression ) and IC ( overall mood state ) and the LC-self ratings ( Pearson coefficient r = .488 , r = .721 and r = .65 , respectively ; all p < .001 ) . Conclusions The LC-self shows a significant correlation and good concordance with st and ard cross sectional affective rating scales , suggesting that the LC-self is a valid and time and money saving alternative to the clinician-rated version which should be incorporated in future clinical research in bipolar disorder . Generalizability of the results is limited by the selection of highly motivated patients in specialized bipolar centres and by the open design of the study BACKGROUND Psychosocial interventions for bipolar disorder are frequently unavailable and re source intensive . Mobile technology may improve access to evidence -based interventions and may increase their efficacy . We evaluated the feasibility , acceptability and efficacy of an augmentative mobile ecological momentary intervention targeting self-management of mood symptoms . METHODS This was a r and omized single-blind controlled trial with 82 consumers diagnosed with bipolar disorder who completed a four-session psychoeducational intervention and were assigned to 10 weeks of either : 1 ) mobile device delivered interactive intervention linking patient-reported mood states with personalized self-management strategies , or 2 ) paper- and -pencil mood monitoring . Participants were assessed at baseline , 6 weeks ( mid-point ) , 12 weeks ( post-treatment ) , and 24 weeks ( follow up ) with clinician-rated depression and mania scales and self-reported functioning . RESULTS Retention at 12 weeks was 93 % and both conditions were associated with high satisfaction . Compared to the paper- and -pencil condition , participants in the augmented mobile intervention condition showed significantly greater reductions in depressive symptoms at 6 and 12 weeks ( Cohen׳s d for both were d=0.48 ) . However , these effects were not maintained at 24-weeks follow up . Conditions did not differ significantly in the impact on manic symptoms or functional impairment . LIMITATIONS This was not a definitive trial and was not powered to detect moderators and mediators . CONCLUSIONS Automated mobile-phone intervention is feasible , acceptable , and may enhance the impact of brief psychoeducation on depressive symptoms in bipolar disorder . However , sustainment of gains from symptom self-management  mobile interventions , once stopped , may be limited Background New technologies have recently been used for monitoring signs and symptoms of mental health illnesses and particularly have been tested to improve the outcomes in bipolar disorders . Web-based psychoeducational programs for bipolar disorders have also been implemented , yet to our knowledge , none of them have integrated both approaches in one single intervention . The aim of this project is to develop and vali date a smartphone application to monitor symptoms and signs and empower the self-management of bipolar disorder , offering customized embedded psychoeducation contents , in order to identify early symptoms and prevent relapses and hospitalizations . Methods / design The project will be carried out in three complementary phases , which will include a feasibility study ( first phase ) , a qualitative study ( second phase ) and a r and omized controlled trial ( third phase ) comparing the smartphone application ( SIMPLe ) on top of treatment as usual with treatment as usual alone . During the first phase , feasibility and satisfaction will be assessed with the application usage log data and with an electronic survey . Focus groups will be conducted and technical improvements will be incorporated at the second phase . Finally , at the third phase , survival analysis with multivariate data analysis will be performed and relationships between socio-demographic , clinical variables and assessment s scores with relapses in each group will be explored . Discussion This project could result in a highly available , user-friendly and not costly monitoring and psychoeducational intervention that could improve the outcome of people suffering from bipolar disorders in a practical and secure way . Trial registration Clinical Trials.gov : NCT02258711 ( October 2014 ) CONTEXT Despite the availability of efficacious treatments , the long-term course of bipolar disorder is often unfavorable . OBJECTIVE To test the effectiveness of a multicomponent intervention program to improve the quality of care and long-term outcomes for persons with bipolar disorder . DESIGN R and omized controlled trial with allocation concealment and blinded outcome assessment . SETTING Mental health clinics of a group-model prepaid health plan . PATIENTS Of 785 patients in treatment for bipolar disorder who were invited to participate , 509 attended an evaluation appointment , 450 were found eligible to participate , and 441 enrolled in the trial . INTERVENTIONS Participants were r and omly assigned to a multicomponent intervention program or to continued care as usual . Three nurse care managers provided a 2-year systematic intervention program , including the following : a structured group psychoeducational program , monthly telephone monitoring of mood symptoms and medication adherence , feedback to treating mental health providers , facilitation of appropriate follow-up care , and as-needed outreach and crisis intervention . MAIN OUTCOME MEASURES In-person blinded research interviews every 3 months assessed mood symptoms using the Longitudinal Interval Follow-up Examination . Health plan administrative records were used to assess the use and cost of mental health services . RESULTS Intent-to-treat analyses demonstrated that the intervention significantly reduced the mean level of mania symptoms ( z = 2.09 , P = .04 ) and the time with significant mania symptoms ( 19.2 vs 24.7 weeks ; F(1 ) = 6.0 , P = .01 ) . There was no significant intervention effect on mean level of depressive symptoms ( z = 0.19 , P = .85 ) or time with significant depressive symptoms ( 47.6 vs 50.7 weeks ; F(1 ) = 0.56 , P = .45 ) . Benefits of the intervention were found only in a subgroup of 343 persons with clinical ly significant mood symptoms  at the baseline assessment . The incremental cost ( adjusted ) of the intervention was 1251 dollars ( 95 % confidence interval , 55 - 2446 dollars ) , including approximately 800 dollars for the intervention program services and an approximate 500 dollars increase in the costs of other mental health services . CONCLUSIONS Population -based systematic care programs can significantly reduce the frequency and severity of mania in bipolar disorder , and cost increases are modest considering the clinical gains . The incorporation of more specific cognitive and behavioral content or more effective medication regimens may be necessary to significantly reduce the symptoms of depression BACKGROUND Episodes of depression are the most frequent cause of disability among patients with bipolar disorder . The effectiveness and safety of st and ard antidepressant agents for depressive episodes associated with bipolar disorder ( bipolar depression ) have not been well studied . Our study was design ed to determine whether adjunctive antidepressant therapy reduces symptoms of bipolar depression without increasing the risk of mania . METHODS In this double-blind , placebo-controlled study , we r and omly assigned subjects with bipolar depression to receive up to 26 weeks of treatment with a mood stabilizer plus adjunctive antidepressant therapy or a mood stabilizer plus a matching placebo , under conditions generalizable to routine clinical care . A st and ardized clinical monitoring form adapted from the mood-disorder modules of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders , fourth edition , was used at all follow-up visits . The primary outcome was the percentage of subjects in each treatment group meeting the criterion for a durable recovery ( 8 consecutive weeks of euthymia ) . Secondary effectiveness outcomes and rates of treatment-emergent affective switch ( a switch to mania or hypomania early in the course of treatment ) were also examined . RESULTS Forty-two of the 179 subjects ( 23.5 % ) receiving a mood stabilizer plus adjunctive antidepressant therapy had a durable recovery , as did 51 of the 187 subjects ( 27.3 % ) receiving a mood stabilizer plus a matching placebo ( P=0.40 ) . Modest nonsignificant trends favoring the group receiving a mood stabilizer plus placebo were observed across the secondary outcomes . Rates of treatment-emergent affective switch were similar in the two groups . CONCLUSIONS The use of adjunctive , st and ard antidepressant medication , as compared with the use of mood stabilizers , was not associated with increased efficacy or with increased risk of treatment-emergent affective switch . Longer-term outcome studies are needed to fully assess the benefits and risks of antidepressant therapy for bipolar disorder . ( Clinical Trials.gov number , NCT00012558 [ Clinical Trials.gov ] . ) Background The stepped-care approach , where people with early symptoms of depression are stepped up from low-intensity interventions to higher-level interventions as needed , has the potential to assist many people with mild depressive symptoms .  Self-monitoring techniques assist people to underst and their mental health symptoms by increasing their emotional self-awareness ( ESA ) and can be easily distributed on mobile phones at low cost . Increasing ESA is an important first step in psychotherapy and has the potential to intervene before mild depressive symptoms progress to major depressive disorder . In this secondary analysis we examined a mobile phone self-monitoring tool used by young people experiencing mild or more depressive symptoms to investigate the relationships between  self-monitoring  , ESA , and depression . Objectives We tested two main hypotheses : ( 1 ) people who monitored their mood , stress , and coping strategies would have increased ESA from pretest to 6-week follow-up compared with an attention comparison group , and ( 2 ) an increase in ESA would predict a decrease in depressive symptoms . Methods We recruited patients aged 14 to 24 years from rural and metropolitan general practice s. Eligible participants were identified as having mild or more mental health concerns by their general practitioner . Participants were r and omly assigned to either the intervention group ( where mood , stress , and daily activities were monitored ) or the attention comparison group ( where only daily activities were monitored ) , and both groups self-monitored for 2 to 4 weeks . R and omization was carried out electronically via r and om seed generation , by an in-house computer programmer ; therefore , general practitioners , participants , and research ers were blinded to group allocation at r and omization . Participants completed pretest , posttest , and 6-week follow-up measures of the Depression Anxiety Stress Scale and the ESA Scale . We estimated a parallel process latent growth curve model ( LGCM ) using Mplus to test the indirect effect of the intervention on depressive symptoms via the mediator ESA , and calculated 95 % bias-corrected bootstrapping confidence intervals ( CIs ) . Results Of the 163 participants assessed for eligibility , 118 were r and omly assigned and 114 were included in analyses ( 68 in the intervention group and 46 in the comparison group ) . A parallel process LGCM estimated the indirect effect of the intervention on depressive symptoms via ESA and was shown to be statistically significant based on the 95 % bias-corrected bootstrapping CIs not containing zero ( –6.366 to –0.029 ) . The proportion of the maximum possible indirect effect estimated was κ2 = .54 ( 95 % CI .426–.640 ) . Conclusions This study supported the hypothesis that self-monitoring increases ESA , which in turn decreases depressive symptoms for young people with mild or more depressive symptoms . Mobile phone self-monitoring programs are ideally suited to first-step intervention programs for depression in the stepped-care approach , particularly when ESA is targeted as a mediating factor . Trial Registration Clinical Trials.gov NCT00794222 ; http:// clinical trials.gov/ct2/show/NCT00794222 ( Archived by WebCite at http://www.webcitation.org/65lldW34k BACKGROUND AND OBJECTIVE Clinicians often find it difficult to differentiate between subobtimal adherence and nonresponse to medical treatment if a patient 's clinical condition does not improve . This study aim ed to evaluate an adherence self-report tool to assess adherence to blood pressure lowering medication . STUDY DESIGN AND SETTING Participants were 245 patients with uncontrolled hypertension from 21 general practice s taking part in a r and omized trial . Prior to r and omization , participants were asked to indicate which of six descriptions ( adherence levels ) would most closely describe their medication taking and were given electronic medication monitors for 30 days . We used multivariable regression analysis to compare the adherence self-report tool with electronic monitoring . RESULTS There was strong evidence that a drop in one adherence level from level 1 ( highest level ) to level 2 and from level 2 to level 3 - 6 ( six being the lowest ) combined was associated with a decrease in timing compliance of approximately 5 % ( test for trend : P = 0.0004 ) . CONCLUSION Adherence assessed by a brief self-report tool was associated with timing compliance obtained through electronic monitoring in patients taking blood pressure lowering medication . Further research is required to investigate the validity of this tool in patients with lower adherence levels and in a nontrial population OBJECTIVES Everyday care of bipolar disorder typically falls short of evidence -based practice . This report describes the design and implementation of a r and omized trial evaluating a systematic program to improve quality and continuity of care for bipolar disorder . METHODS Computerized records of a large health plan were used to identify all patients treated for bipolar disorder . Following a baseline diagnostic assessment , eligible and consenting patients were r and omly assigned to either continued usual care or a multifaceted intervention program including : development of a collaborative treatment plan , monthly telephone monitoring by a dedicated nurse care manager , feedback of monitoring results and algorithm-based medication recommendations to treating mental health providers , as-needed outreach and care coordination , and a structured psychoeducational group program ( the Life Goals Program by Bauer and McBride ) delivered by the nurse care manager . Blinded assessment s of clinical outcomes , functional outcomes , and treatment process were conducted every 3 months for 24 months . RESULTS A total of 441 patients ( 64 % of those eligible ) consented to participate and 43 % of enrolled patients met criteria for current major depressive episode , manic episode , or hypomanic episode .  An additional 39 % reported significant subthreshold symptoms , and 18 % reported minimal or no current mood symptoms . Of patients assigned to the intervention program , 94 % participated in telephone monitoring and 70 % attended at least one group session . CONCLUSIONS In a population -based sample of patients treated for bipolar disorder , approximately two-thirds agreed to participate in a r and omized trial comparing alternative treatment strategies . Nearly all patients accepted regular telephone monitoring and over two-thirds joined a structured group program . Future reports will describe clinical effectiveness and cost-effectiveness of the intervention program compared with usual care BACKGROUND There is a recent appreciation that patients with bipolar disorder spend a substantial period of time with minor or subsyndromal mood symptoms both manic and depressive . This study examined time spent in minor and subsyndromal mood states as well as with mania and depression in a cohort of well characterized bipolar I and II patients who were followed prospect ively for an average of three years . METHOD Detailed life-charting data were obtained from 138 patients with bipolar disorder . Mood states were characterized as euthymic , subsyndromal , minor or major affective episodes based on rigorously defined criteria . The amount of time spent in these mood states during follow-up was examined . RESULTS Patients in the total sample and within each bipolar subtype spent approximately half of their time euthymic . The remainder of the time was spent in varying severity of mood states . However , the majority of time was spent with minor and subsyndromal symptoms , both manic and depressive . Bipolar I patients differ from bipolar II in that significantly more time was spent with subsyndromal , minor and manic symptoms . There was no difference in time spent with depressive symptoms between the two groups . CONCLUSIONS Patients with bipolar disorder spend a substantial proportion of time with depressive or manic symptoms with the preponderance being minor or subsyndromal . Awareness of subthreshold symptoms in bipolar disorders and treatment of such symptoms may be improved by establishing guidelines that specifically outline appropriate strategies for reducing the duration of subsyndromal symptoms in bipolar disorder INTRODUCTION Aripiprazole is a novel second-generation antipsychotic approved for the treatment of bipolar disorder in adults but there is no systematic data available in pediatric bipolar disorder . METHODS This was an 8-week , open-label , prospect i ve study of aripiprazole 9.4+/-4.2 mg/day monotherapy to assess the efficacy and tolerability of this compound in treating pediatric bipolar disorder . Assessment s included the Young Mania Rating Scale , Clinical Global Impressions-Improvement scale , and Brief Psychiatric Rating Scale . Adverse events were assessed through spontaneous self-reports , vital signs weight monitoring , and laboratory analysis . RESULTS Fifteen of the 19 bipolar youth ( 79 % ) completed the study .  Aripiprazole treatment was associated with clinical ly and statistically significant improvement in mean Young Mania Rating Scale scores ( -18.0+/-6.9 , P<.0001 ) . With the important exception of two cases of extrapyramidal symptoms that precipitated dropout , aripiprazole was well tolerated with no statistically significant increase in body weight ( 1.8+/-1.7 kg , P=.2 ) . CONCLUSION Open-label aripiprazole treatment was beneficial in the treatment of mania in youth with bipolar disorder . Future placebo-controlled , double-blind studies are warranted Aim : To evaluate the safety and efficacy of lamotrigine monotherapy as an acute treatment of bipolar mood elevation in children with bipolar spectrum disorders . Method : This was a 12‐week , open‐label , prospect i ve trial of lamotrigine monotherapy to assess the effectiveness and tolerability of this compound in treating pediatric bipolar disorder . Assessment s included the Young Mania Rating Scale ( YMRS ) , Clinical Global Impressions‐Improvement scale ( CGI‐I ) , Children 's Depression Rating Scale ( CDRS ) , and Brief Psychiatric Rating Scale ( BPRS ) . Adverse events were assessed through spontaneous self‐reports , vital signs weight monitoring , and laboratory analysis . Results : Thirty‐nine children with bipolar disorder ( YMRS at entry : 31.6 ± 5.5 ) were enrolled in the study and 22 ( 56 % ) completed the 12‐week trial . Lamotrigine was slowly titrated to an average endpoint dose of 160.7 ± 128.3 in subjects < 12 years of age ( N = 22 ) and 219.1 ± 172.2 mg/day in children 12–17 years of age ( N = 17 ) . Treatment with lamotrigine was associated with statistically significant levels of improvement in mean YMRS scores ( −14.9 ± 9.7 , P < 0.001 ) at endpoint . Lamotrigine treatment also result ed in significant improvement in the severity of depressive , attention‐deficit/hyperactivity disorder ( ADHD ) , and psychotic symptoms  . Lamotrigine was generally well tolerated with marginal increase in body weight ( 47.0 ± 18.0 kg vs. 47.2 ± 17.9 kg , P= 0.6 ) and was not associated with abnormal changes in laboratory parameters . Several participants were discontinued due to skin rash ; in all cases , the rash resolved shortly after discontinuation of treatment . No patient developed Steven Johnson syndrome . Conclusions : Open‐label lamotrigine treatment appears to be beneficial in the treatment of bipolar disorder and associated conditions in children . Future placebo‐controlled , double‐blind studies are warranted to confirm these findings Continuation treatment for bipolar disorder often consists of a mood stabilizer and a second-generation antipsychotic . Quetiapine has been shown to be an effective treatment for acute mania and acute bipolar depression , but there are limited data for its use in continuation treatment . This study examined the effectiveness of open-label adjunctive quetiapine therapy for continuation treatment in patients with bipolar disorder . Prospect ively collected life chart data from 63 out patients with bipolar disorders , most recent episodes depressed , manic , or cycling , who received adjunctive quetiapine therapy as part of st and ard acute treatment were analyzed . Patients had 4 or more weeks of prequetiapine baseline data and at least 2 weeks of quetiapine treatment with no other medication changes . Patients were grouped by baseline symptoms ; depression only , mania only , or both mania and depression ( cycling group ) . Owing to small mania and well groups ( n=4 ) , differences between depression and cycling groups were examined and mania and well groups excluded . Fifty-five patients were included in the analyses . The primary outcome measure was change in mood severity from baseline to change in treatment regimen , as measured by the NIMH Life Charting Method . Patients received adjunctive quetiapine for a mean of 122 ( SD=149 ) days . Both groups showed significant improvement in depression ratings and time spent depressed by week 10 . Both groups showed significant improvement in overall mood . No between-group differences in improvement were found . Adjunctive quetiapine may be useful as continuation treatment in bipolar population s with both pure depressive and cycling symptoms . Further controlled studies are warranted BACKGROUND Bipolar disorders ( BP ) are frequently diagnosed and treated as pure depression initially ; accurate diagnosis often being delayed by 8 to 10 years . In prospect i ve studies , the presence of hypomanic symptoms in adolescence is strongly predictive of later bipolar disorders . As such , an instrument for self- assessment of hypomanic symptoms might increase the detection of suspected and of manifest , but under-treated , cases of bipolar disorders . METHODS The multi-lingual hypomania checklist ( HCL-32 ) has been developed and is being tested internationally . This preliminary paper reports the performance of the scale in distinguishing individuals with BP ( N=266 ) from those with major depressive disorder ( MDD ; N=160 ) . The sample s were adult psychiatry patients recruited in Italy ( N=186 ) and Sweden ( N=240 ) . RESULTS The sample s reported similar clinical profiles and the structure for the HCL-32 demonstrated two main factors identified as " active/elated " hypomania and " risk-taking/irritable " hypomania . The HCL-32 distinguished between BP and MDD with a sensitivity of 80 % and a specificity of 51 % . LIMITATIONS Although the HCL-32 is a sensitive instrument for hypomanic symptoms , it does not distinguish between BP-I and BP-II disorders . CONCLUSIONS Future studies should test if different combinations of items , possibly recording the consequences of hypomania , can distinguish between these BP subtypes BACKGROUND Systematic and accurate depiction of a patient 's course of illness is crucial for assessing the efficacy of maintenance treatments for bipolar disorder . This need to rate the long-term prospect i ve course of illness led to the development of the National Institute of Mental Health prospect i ve Life Chart Methodology ( NIMH-LCM-p or LCM ) . The NIMH-LCM-p allows for the daily assessment of mood and episode severity based on the degree of mood associated functional impairment . We have previously presented preliminary evidence of the reliability and validity of the LCM , and its utility in clinical trials . This study is a further and more extensive validation of the clinician rated NIMH-LCM-p . METHODS Subjects included 270 bipolar patients from the five sites participating in the Stanley Foundation Bipolar Network . Daily prospect i ve LCM ratings on the clinician form were initiated upon entry , in addition to at least monthly ratings with the Inventory of Depressive Symptomatology-clinician rated ( IDS-C ) , the Young Mania Rating Scale ( YMRS ) and the Global Assessment of Functioning ( GAF ) . We correlated appropriate measures and time domains of the LCM with the IDS-C , YMRS and GAF . RESULTS Severity of depression on the LCM and on the IDS-C were highly correlated in 270 patients ( r = -0.785 , P < 0.001 ) . Similarly , a strong correlation was found between LCM mania and the YMRS ( r = 0.656 , P < 0.001 ) and between the LCM average severity of illness and the GAF ( r = -0.732 , P < 0.001 ) . CONCLUSIONS These data further demonstrate the validity and potential utility of the NIMH-LCM-p for the detailed daily longitudinal assessment of manic and depressive severity and course , and response to treatment BACKGROUND Despite the availability of efficacious medications and psychotherapies , care of bipolar disorder in everyday practice is often deficient . This trial evaluated the effectiveness of a multi-component care management program in a population -based sample of people with bipolar disorder . METHOD Four hundred and forty-one patients treated for bipolar disorder during the prior year were r and omly assigned to continued usual care or usual care plus a systematic care management program including : initial assessment and care planning , monthly telephone monitoring including brief symptom assessment and medication monitoring , feedback to and coordination with the mental health treatment team , and a structured group psychoeducational program -- all provided by a nurse care manager . Blinded quarterly assessment s generated week-by-week ratings of severity of depression and mania symptoms using the Longitudinal Interval Follow-Up Evaluation . RESULTS Participants assigned to the intervention group had significantly lower mean mania ratings averaged across the 12-month follow-up period ( Z= 2.44 , p=0.015 ) and approximately one-third less time in hypomanic or manic episode ( 2.59 weeks v. 1.69 weeks ) . Mean depression ratings across the entire follow-up period did not differ significantly between the two groups , but the intervention group showed a greater decline in depression ratings over time ( Z statistic for group-by-time interaction = 1.98 , p = 0.048 ) . CONCLUSIONS A systematic care program for bipolar disorder significantly reduces risk of mania over 12 months . Preliminary results suggest a growing effect on depression over time , but longer follow-up will be needed OBJECTIVES Health care providers have an important role in acknowledging and supporting patients ' self-management of chronic illnesses such as bipolar disorder . This report describes the development and evaluation of a brief measure for assessing patient perception of providers ' support for self-management of bipolar disorder . METHODS A 10-item measure was developed combining generic items from an existing measure of providers ' autonomy supportive versus controlling style with items specific to the self-management of bipolar disorder . The psychometric properties of the measure and its relation to clinical variables were evaluated in a sample of patients enrolled in an ongoing r and omized intervention trial . RESULTS Data were obtained from 420 patients with a chart diagnosis of bipolar disorder ( mean age=44 , 68 % female , 88 % Caucasian ) . The proportion of missing responses for items ranged from 0 to 3 % . Reliability coefficient alpha for the full scale was 0.94 . Corrected item-total correlations for individual items ranged from 0.70 to 0.83 . Factor analysis identified a single factor accounting for 67 % of total variance . Factor loadings for individual items were all at least 0.75 . The measure showed moderate positive correlations with measures of self-efficacy for managing bipolar disorder ( r=0.34 ; p < 0.001 ) , treatment satisfaction ( r=0.63 ; p < 0.001 ) , small negative correlations with measures of mania symptoms ( r=-0.11 ; p < 0.03 ) and depressive symptoms ( r=-0.09 ; p < 0.10 ) . CONCLUSIONS This measure shows good psychometric properties and good evidence for convergent and discriminant validity . It is promising for assessing an important aspect of care for bipolar disorder BACKGROUND Longitudinal mood instability is the essential feature of bipolar disorder , however most rating scales are cross sectional in nature , and focus on acute symptoms . By contrast , the NIMH Life Chart Methodology ( LCM ) characterizes in detail the severity , duration , and frequency of mood episodes . Adherence to daily rating , however , tends to be low . In this study an online version of the LCM , design ed to enhance adherence , was compared to the st and ard paper version . METHODS Patients from a mood disorders specialty clinic were r and omized to the st and ard LCM or an online , open- source adaptation . The online version used hypertext links embedded in a daily email as the primary rating interface . Participants rated for 90 days . The total number of days rated and the number of days with complete data were compared for the two groups . RESULTS Forty-eight patients participated in the study . The online group rated approximately twice as many days compared to the st and ard group ( 44.3 versus 20.4 , p=.029 ) . The online group also entered complete data for a larger portion of days ( 55.2 % versus 27.7 % , p=.039 ) . LIMITATIONS This was a small , short-term study . The implication s for longer-term rating are unclear . CONCLUSIONS Despite the advantages of documenting mood fluctuation on a daily basis , the LCM is not commonly used , in part because ensuring adequate adherence can be re source intensive . An easily accessible online adaptation that utilizes email checking behavior can make this tool available to a wider range of patients
Conclusions  Electronic self-monitoring of mood in depression appears to be a valid measure of mood in contrast to self-monitoring of mood in mania .
Background Various paper-based mood charting instruments are used in the monitoring of symptoms in bipolar disorder .
During recent years an increasing number of electronic self-monitoring tools have been developed .
The objectives of this systematic review were 1 ) to evaluate the validity of electronic self-monitoring tools as a method of evaluating mood compared to clinical rating scales for depression and mania and 2 ) to investigate the effect of electronic self-monitoring tools on clinical ly relevant outcomes in bipolar disorder .
There are yet few studies on the effect of  electronic self-monitoring of mood  in bipolar disorder .