title: 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 Long-term effectiveness and cost of a systematic care program for bipolar disorder. Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial. A randomized head to head trial of MoodSwings.net.au: an Internet based self-help program for bipolar disorder. Self-monitoring and psychoeducation in bipolar patients with a smart-phone application (SIMPLe) project: design, development and studies protocols Feasibility and acceptability of web-based enhanced relapse prevention for bipolar disorder (ERPonline): trial protocol. The Ins and Outs of an Online Bipolar Education Program: A Study of Program Attrition An online randomised controlled trial to assess the feasibility, acceptability and potential effectiveness of 'Living with Bipolar': a web-based self-management intervention for bipolar disorder: trial design and protocol. The 16-Item quick inventory of depressive symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression Beating Bipolar: exploratory trial of a novel Internet-based psychoeducational treatment for bipolar disorder. The Bipolar Interactive Psychoeducation (BIPED) study: trial design and protocol Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment Saving time and money: a validation of the self ratings on the prospective NIMH life-chart method (NIMH-LCM) Long-term symptomatic status of bipolar I vs. bipolar II disorders. A prospective, longitudinal study of percentage of time spent ill in patients with bipolar I or bipolar II disorders. Computer-assisted self-assessment in persons with severe mental illness. Online mindfulness-based intervention for late-stage bipolar disorder: pilot evidence for feasibility and effectiveness. Subsyndromal symptoms assessed in longitudinal, prospective follow-up of a cohort of patients with bipolar disorder. Preliminary evidence of the reliability and validity of the prospective life-chart methodology (LCM-p). Augmenting psychoeducation with a mobile intervention for bipolar disorder: a randomized controlled trial. Patient compliance with paper and electronic diaries. Validation of the prospective NIMH-Life-Chart Method (NIMH-LCM-p) for longitudinal assessment of bipolar illness. A web-based preventive intervention program for bipolar disorder: outcome of a 12-months randomized controlled trial. A randomized comparison of online and paper mood charts for people with bipolar disorder. The Stanley Foundation Bipolar Treatment Outcome Network. I. Longitudinal methodology. A Pilot Study of Mood Ratings Captured by Mobile Phone Versus Paper-and-Pencil Mood Charts in Bipolar Disorder Development of an online intervention for bipolar disorder. www.moodswings.net.au A web-based self-management intervention for Bipolar Disorder 'living with bipolar': a feasibility randomised controlled trial. A prospective study of the trajectories of clinical insight, affective symptoms, and cognitive ability in bipolar disorder.
abstract: 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 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 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 BACKGROUND Adjunctive psychosocial interventions are efficacious in bipolar disorder , but their incorporation into routine management plans are often confounded by cost and access constraints . We report here a comparative evaluation of two online programs hosted on a single website ( www.moodswings.net.au ) . A basic version , called MoodSwings ( MS ) , contains psychoeducation material and asynchronous discussion boards ; and a more interactive program , MoodSwings Plus ( MS-Plus ) , combined the basic psychoeducation material and discussion boards with elements of Cognitive Behavioral Therapy . These programs were evaluated in a head-to-head study design . METHOD Participants with Bipolar I or II disorder ( n=156 ) were r and omized to receive either MoodSwings or MoodSwings-Plus .  Outcomes included mood symptoms , the occurrence of relapse , functionality , Locus of Control , social support , quality of life and medication adherence . RESULTS Participants in both groups showed baseline to endpoint reductions in mood symptoms and improvements in functionality , quality of life and medication adherence . The MoodSwings-Plus group showed a greater number of within-group changes on symptoms and functioning in depression and mania , quality of life and social support , across both poles of the illness . MoodSwings-Plus was superior to MoodSwings in improvement on symptoms of mania scores at 12 months ( p=0.02 ) but not on the incidence of recurrence . LIMITATIONS The study did not have an attention control group and therefore could not demonstrate efficacy of the two active arms . There was notable ( 81 % ) attrition by 12 months from baseline . CONCLUSION This study suggests that both CBT and psychoeducation delivered online may have utility in the management of bipolar disorder . They are feasible , readily accepted , and associated with improvement 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 ) BACKGROUND Relapse prevention interventions for Bipolar Disorder are effective but implementation in routine clinical services is poor . Web-based approaches offer a way to offer easily accessible access to evidence based interventions at low cost , and have been shown to be effective for other mood disorders . METHODS / DESIGN This protocol describes the development and feasibility testing of the ERPonline web-based intervention using a single blind r and omised controlled trial . Data will include the extent to which the site was used , detailed feedback from users about their experiences of the site , reported benefits and costs to mental health and wellbeing of users , and costs and savings to health services . We will gain an estimate of the likely effect size of ERPonline on a range of important outcomes including mood , functioning , quality of life and recovery . We will explore potential mechanisms of change , giving us a greater underst and ing of the underlying processes of change , and consequently how the site could be made more effective . We will be able to determine rates of recruitment and retention , and identify what factors could improve these rates . DISCUSSION The findings will be used to improve the site in accordance with user needs , and inform the design of a large scale evaluation of the clinical and cost effectiveness of ERPonline . They will further contribute to the growing evidence base for web-based interventions design ed to support people with mental health problems Background The science of eHealth interventions is rapidly evolving . However , despite positive outcomes , evaluations of eHealth applications have thus far failed to explain the high attrition rates that are associated with some eHealth programs . Patient adherence remains an issue , and the science of attrition is still in its infancy . To our knowledge , there has been no in-depth qualitative study aim ed at identifying the reasons for nonadherence to— and attrition from— online interventions . Objective This paper explores the predictors of attrition and participant-reported reasons for nonadherence to an online psycho-education program for people newly diagnosed with a bipolar disorder . Methods As part of an ongoing r and omized controlled trial ( RCT ) evaluating an online psycho-education program for people newly diagnosed with a bipolar disorder , we undertook an in-depth qualitative study to identify participants ’ reasons for nonadherence to , and attrition from , the online intervention as well as a quantitative study investigating predictors of attrition . Within the RCT , 370 participants were r and omly allocated to 1 of 2 active interventions or an attention control condition . Descriptive analyses and chi-square tests were used to explore the completion rates of 358 participants , and st and ard regression analysis was used to identify predictors of attrition . The data from interviews with a sub sample of 39 participants who did not complete the online program  were analyzed using “ thematic analysis ” to identify patterns in reported reasons for attrition . Results Overall , 26.5 % of the sample did not complete their assigned intervention . St and ard multiple regression analysis revealed that young age ( P= .004 ) , male gender ( P= .001 ) , and clinical recruitment setting ( P= .001 ) were significant predictors of attrition ( F7,330= 8.08 , P < .001 ) . Thematic analysis of interview data from the noncompleter sub sample revealed that difficulties associated with the acute phases of bipolar disorder , not wanting to think about one ’s illness , and program factors such as the information being too general and not personally tailored were the major reasons for nonadherence . Conclusions The dropout rate was equivalent to other Internet interventions and to face-to-face therapy . Findings from our qualitative study provide participant-reported reasons for discontinuing the online intervention , which , in conjunction with the quantitative investigations about predictors , add to underst and ing about Internet interventions . However , further research is needed to determine whether there are systematic differences between those who complete and those who do not complete eHealth interventions . Ultimately , this may lead to the identification of population subgroups that most benefit from eHealth interventions and to informing the development of strategies to improve adherence . Trial Registration ACTRN12608000411347 ; http://www.anzctr.org.au/ACTRN12608000411347.aspx ( Archived by WebCite at http://www.webcitation.org/5uX4uYwVN BACKGROUND Bipolar Disorder ( BD ) is a common and severe form of mental illness . Pharmacotherapy is the main treatment offered , but has limited effectiveness , and there is increasing evidence that people with BD respond well to psychological interventions . Inequalities in access to face-to-face psychological interventions mean many people seek support outside of routine health services . AIM To assess a recovery informed web-based self-management intervention for BD to increase access to psychological support . METHOD A small online r and omised controlled trial ( RCT ) will evaluate the feasibility , acceptability and potential effectiveness of the intervention compared to treatment as usual ( TAU ) .  Feasibility and acceptability will be assessed by recruitment , adherence and dropout rates , website usage statistics , user satisfaction scales and a series of qualitative interviews . Effectiveness will be assessed on a range of outcome measures including quality of life , mood symptoms , coping , recovery , and illness beliefs . ANALYSIS Rates of adherence and dropout will be analysed using logistic regression models with health , socioeconomic and treatment factors as explanatory variables . Changes in quality of life mean scores , contrasting between arms , will be assessed using r and om effects models . An exploratory analysis will be performed on the secondary outcomes . Thematic analysis ( Braun & Clarke , 2006 ) will be used to analyse the qualitative interviews . DISCUSSION The benefits , challenges and method ological challenges of developing a web-based intervention and conducting an RCT online are discussed . CONCLUSION The results of this trial will inform a definitive trial ; and the implementation phase will aim to assess the potential for use within the NHS The 16-item Quick Inventory of Depressive Symptomatology ( QIDS ) , a new measure of depressive symptom severity derived from the 30-item Inventory of Depressive Symptomatology ( IDS ) , is available in both self-report ( QIDS-SR(16 ) ) and clinician-rated ( QIDS-C(16 ) ) formats . This report evaluates and compares the psychometric properties of the QIDS-SR(16 ) in relation to the IDS-SR(30 ) and the 24-item Hamilton Rating Scale for Depression ( HAM-D(24 ) ) in 596 adult out patients treated for chronic nonpsychotic , major depressive disorder .  Internal consistency was high for the QIDS-SR(16 ) ( Cronbach 's alpha = .86 ) , the IDS-SR(30 ) ( Cronbach 's alpha = .92 ) , and the HAM-D(24 ) ( Cronbach 's alpha = .88 ) .  QIDS-SR(16 ) total scores were highly correlated with IDS-SR(30 ) ( .96 ) and HAM-D(24 ) ( .86 ) total scores . Item-total correlations revealed that several similar items were highly correlated with both QIDS-SR(16 ) and  IDS-SR(30 ) total scores . Roughly 1.3 times the QIDS-SR(16 )  total score is predictive of the HAM-D(17 ) ( 17-item version of the HAM-D ) total score . The QIDS-SR(16 ) was as sensitive to symptom change as the IDS-SR(30 ) and HAM-D(24 ) , indicating high concurrent validity for all three scales . The QIDS-SR(16 ) has highly acceptable psychometric properties , which supports the usefulness of this brief rating of depressive symptom severity in both clinical and research setting OBJECTIVES Psychoeducational approaches are promising interventions for the long-term management of bipolar disorder . In consultation with professionals , patients , and their families we have developed a novel web-based psychoeducational intervention for bipolar disorder called Beating Bipolar . We undertook a preliminary exploratory r and omized trial to examine efficacy , feasibility and acceptability . METHODS This was an exploratory r and omized controlled trial of Beating Bipolar ( current controlled trials registration number : IS RCT N81375447 ) . The control arm was treatment-as-usual and the a priori primary outcome measure was quality of life [ measured by the brief World Health Organization Quality of Life ( WHOQOL-BREF ) scale ] . Secondary outcomes included psychosocial functioning , insight , depressive and manic symptoms and relapse , and use of healthcare re sources . Fifty participants were r and omized to either the Beating Bipolar intervention plus treatment-as-usual or just treatment-as-usual .  The intervention was delivered over a four-month period and outcomes were assessed six months later . RESULTS There was no significant difference between the intervention and control groups on the primary outcome measure ( total WHOQOL-BREF score ) but there was a modest improvement within the psychological subsection of the WHOQOL-BREF for the intervention group relative to the control group . There were no significant differences between the groups on any of the secondary outcome measures . CONCLUSIONS Beating Bipolar is potentially a safe and engaging intervention which can be delivered remotely to large numbers of patients with bipolar disorder at relatively low cost . It may have a modest effect on psychological quality of life . Further work is required to establish the impact of this intervention on insight , knowledge , treatment adherence , self-efficacy and self-management skills Background Bipolar disorders affect between 3–5 % of the population and are associated with considerable lifelong impairment . Since much of the morbidity associated with bipolar disorder is caused by recurrent depressive symptoms , which are often only poorly responsive to antidepressants , there is a need to develop alternative , non-pharmacological interventions . Psychoeducational interventions have emerged as promising long-term therapeutic options for bipolar disorder . Methods / design The study is an exploratory , individually r and omised controlled trial . The intervention known as ' Beating Bipolar ' is a psychoeducational programme which is delivered via a novel web-based system . We will recruit 100 patients with a diagnosis of DSM-IV bipolar disorder ( including type I and type II ) currently in clinical remission . The primary outcome is quality of life . This will be compared for those patients who have participated in the psychoeducational programme with those who received treatment as usual . Quality of life will be assessed immediately following the intervention as well as 10 months after r and omisation . Secondary outcomes include current depressive and manic symptoms , number of episodes of depression and mania/hypomania experienced during the follow-up period , global functioning , functional impairment and insight . An assessment of costs and a process evaluation will also be conducted which will explore the feasibility and acceptability of the intervention as well as potential barriers to effectiveness . Discussion Bipolar disorder is common , under-recognised and often poorly managed . It is a chronic , life-long , relapsing condition which has an enormous impact on the individual and the economy . This trial will be the first to explore the effectiveness of a novel web-based psychoeducational intervention for patients with bipolar disorder which has potential to be easily rolled out to patients .Trial registration Current Controlled Trials IS RCT Abstract Objective : To determine the efficacy of teaching patients with bipolar disorder ( manic-depressive psychosis ) to identify early symptoms of relapse and seek prompt treatment from health services . Design : Single blind r and omised controlled trial with matching on four baseline variables using a minimisation algorithm . Setting : Mental health services in four NHS trusts ( one teaching , three non-teaching ) . Subjects : 69 patients with bipolar disorder who had had a relapse in the previous 12 months . Interventions : Seven to 12individual treatment sessions from a research psychologist plus routine care or routine care alone . Main outcome measures : Time to first manic or depressive relapse , number of manic or depressive relapses , and social functioning examined by st and ardised interviews every six months for 18 months . Results : 25th centile time to first manic relapse in experimental group was 65weeks compared with 17weeks in the control group . Event curves of time to first manic relapse significantly differed between experimental and control groups ( log rank 7.04 , df=1 , P=0.008 ) , with significant reductions in the number of manic relapses over 18months ( median difference 30 % ( 95 % confidence interval 8 % to 52 % ) , P=0.013 ) . The experimental treatment had no effect on time to first relapse or number of relapses with depression , but it significantly improved overall social functioning ( mean difference 2.0(0.7to 3.2 ) , P=0.003 ) and employment ( mean difference 0.7(0.1to 1.3 ) , P=0.030 ) by 18months . Conclusion : Teaching patients to recognise early symptoms of manic relapse and seek early treatment is associated with important clinical improvements in time to first manic relapse , social functioning , and employment 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 Weekly affective symptom severity and polarity were compared in 135 bipolar I ( BP I ) and 71 bipolar II ( BP II ) patients during up to 20 yr of prospect i ve symptomatic follow-up . The course of BP I and BP II was chronic ; patients were symptomatic approximately half of all follow-up weeks ( BP I 46.6 % and BP II 55.8 % of weeks ) . Most bipolar disorder research has concentrated on episodes of MDD and mania and yet minor and subsyndromal symptoms are three times more common during the long-term course . Weeks with depressive symptoms predominated over manichypomanic symptoms in both disorders ( 31 ) in BP I and BP II at 371 in a largely depressive course ( depressive symptoms=59.1 % of weeks vs. hypomanic=1.9 % of weeks ) . BP I patients had more weeks of cyclingmixed polarity , hypomanic and subsyndromal hypomanic symptoms . Weekly symptom severity and polarity fluctuated frequently within the same bipolar patient , in which the longitudinal symptomatic expression of BP I and BP II is dimensional in nature involving all levels of affective symptom severity of mania and depression . Although BP I is more severe , BP II with its intensely chronic depressive features is not simply the lesser of the bipolar disorders ; it is also a serious illness , more so than previously thought ( for instance , as described in DSM-IV and ICP-10 ) . It is likely that this conventional view is the reason why BP II patients were prescribed pharmacological treatments significantly less often when acutely symptomatic and during intervals between episodes . Taken together with previous research by us on the long-term structure of unipolar depression , we su bmi t that the thrust of our work during the past decade supports classic notions of a broader affective disorder spectrum , bringing bipolarity and recurrent unipolarity closer together . However the genetic variation underlying such a putative spectrum remains to be clarified 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 BACKGROUND It has been difficult to improve care for severe mental illness ( SMI ) in usual care setting s because clinical information is not reliably and efficiently managed . Methods are needed for efficiently collecting this information to evaluate and improve health care quality . Audio computer-assisted self-interviewing ( ACASI ) can facilitate this data collection and has improved outcomes for a number of disorders , suggesting the need to test its accuracy and reliability in people with SMI . METHOD Ninety patients with DSM-IV schizophrenia or schizoaffective disorder ( N = 45 ) or bipolar disorder ( N = 45 ) recruited between Oct. 15 , 2002 , and July 1 , 2003 , were r and omly assigned to 1 of 2 study groups and completed 2 st and ardized symptom surveys ( Revised Behavior and Symptom Identification Scale and the symptom severity scale of the Schizophrenia Outcomes Module 2 ) 20 minutes apart in a crossover study design . Half of the patients first completed the scales via an in-person interview , and the other half first completed the scales via an  ACASI survey self-administered through an Internet browser using a touchscreen developed to meet the cognitive needs of people with SMI . We evaluated attitudes toward ACASI  , underst and ing of the ACASI survey , internal consistency , correlations between the ACASI and interview modes , concurrent validity , and a possible administration mode bias . RESULTS All ACASI and in-person interview scales had similar internal reliability , high correlations ( r = 0.78 - 1.00 ) , and mean scores similar enough as not to be different at p < .05 . A large majority rated the ACASI survey as easier , more enjoyable , more preferable if monthly completion of a survey were required , and more private , and 97 % to 99 % perfectly answered questions about how to use it . CONCLUSION ACASI data collection is reliable among people with bipolar disorder and schizophrenia and could be a valuable tool to improve their care OBJECTIVES People in the late stage of bipolar disorder ( BD ) experience elevated relapse rates and poorer quality of life ( QoL ) compared with those in the early stages . Existing psychological interventions also appear less effective in this group . To address this need , we developed a new online mindfulness-based intervention targeting quality of life ( QoL ) in late stage BD . Here , we report on an open pilot trial of ORBIT ( online , recovery-focused , bipolar individual therapy ) . METHODS Inclusion criteria were : self-reported primary diagnosis of BD , six or more episodes of BD , under the care of a medical practitioner , access to the internet , proficient in English , 18 - 65 years of age . Primary outcome was change ( baseline - post-treatment ) on the Brief QoL.BD  ( Michalak and Murray , 2010 ) . Secondary outcomes were depression , anxiety , and stress measured on the DASS scales ( Lovibond and Lovibond , 1993 ) . RESULTS Twenty-six people consented to participate ( Age M=46.6 years , SD=12.9 , and 75 % female ) . Ten participants were lost to follow-up ( 38.5 % attrition ) . Statistically significant improvement in QoL was found for the completers , t(15)=2.88 , 95 % CI:.89 - 5.98 , p=.011 , ( Cohen׳s dz=.72 , partial η(2)=.36 ) , and the intent-to-treat sample t(25)=2.65 , 95 % CI:.47 - 3.76 , ( Cohen׳s dz=.52 ; partial η(2)=.22 ) . A non-significant trend towards improvement was found on the DASS anxiety scale ( p=.06 ) in both completer and intent-to-treat sample s , but change on depression and stress did not approach significance . LIMITATIONS This was an open trial with no comparison group , so measured improvements may not be due to specific elements of the intervention . Structured diagnostic assessment s were not conducted , and interpretation of effectiveness was limited by substantial attrition . CONCLUSION Online delivery of mindfulness-based psychological therapy for late stage BD appears feasible and effective , and ORBIT warrants full development . Modifications suggested by the pilot study include increasing the 3 weeks duration of the intervention , adding caution s about the impact of extended meditations , and addition of coaching support/monitoring to optimise engagement BACKGROUND Many patients with bipolar disorder ( BD ) do not regain full function following an acute illness episode , but the extent to which this impairment is the result of persistent symptoms has not been well established . This study examined factors associated with persistent subsyndromal symptoms in a well characterized group of BD patients who were prospect ively followed for an average of 3 years . METHODS Detailed life charting data from 138 patients with BD were review ed . Patients were categorized into euthymic , subsyndromal or syndromal groups according to the clinical state during their most recent year of follow-up . The three groups were then examined with respect to comorbidity , function and treatment received . RESULTS Patients with subsyndromal symptoms had high rates of comorbid anxiety disorders , and were more likely to have increased rates of eating disorders as well . Patients with subsyndromal symptoms had lower global assessment of function ( GAF ) scores than euthymic patients , and had as many clinic contacts and medication trials as patients with full episodes of illness . CONCLUSIONS Persistent subsyndromal symptoms in BD patients are associated with high rates of comorbidity that is important to recognize and treat in order to optimize mood and functioning This article describes the use of the NIMH prospect i ve life-charting methodology ( NIMH LCM-p ) in the context of a formal double-blind , clinical trial and provides preliminary evidence of its reliability and validity . Subjects included in this report were 30 out patients with bipolar I and II disorder who completed the first 2 years of a long-term maintenance study : 1 year on carbamazepine or lithium and a crossover to the other in the second year . The LCM-p follows the same types of guidelines and principles utilized in the previously described retrospective life-chart process , allowing for continuity of illness assessment prior and subsequent to study entry . In the LCM-p , daily ratings of severity of mood symptoms based on the degree of associated functional incapacity , provide a more detailed topography of manic and depressive fluctuations . Inter-rater reliability was examined by comparing the severity of daily LCM-p ratings assigned by two raters . In order to assess the validity , we correlated the LCM-p ratings with well-st and ardized scales , including Hamilton and Beck Depression Ratings , Young Mania Ratings and the Global Assessment Scale ( GAS ) . The Kappa scores for inter-rater reliability demonstrated significant and satisfactory strength of agreement with no fall off over 14 days prior to the rating interview . Strong correlations were found : ( 1 ) between the LCM-p average severity for depression rating and the mean Hamilton Depression Rating ( r = 0.86 , p < .001 ) , and the Beck Depression Inventory ( r = 0.73 , p < .001 ) ; 2 ) between the LCM-p average severity for mania rating and the Young Mania Rating Scale ( r = 0.61 , p < .001 ) ; and ( 3 ) between the LCM-p average severity and the GAS ( r = -0.81 , p < .001 ) . These preliminary data suggest the reliability and validity of the NIMH-LCM-p in assessing manic and depressive episode severity . It also provides a useful continuous daily measure of affective illness-related symptom fluctuations that allows for detailed prospect i ve assessment of frequency and pattern of illness , treatment response , and continuity with retrospective life chart assessment 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 Paper diaries are commonly used in health care and clinical research to assess patient experiences . There is concern that patients do not comply with diary protocol s , possibly invalidating the benefit of diary data . Compliance with paper diaries was examined with a paper diary and with an electronic diary that incorporated compliance-enhancing features .  Participants were chronic pain patients and they were assigned to use either a paper diary instrumented to track diary use or an electronic diary that time-stamped entries . Participants were instructed to make three pain entries per day at predetermined times for 21 consecutive days . Primary outcome measures were reported vs actual compliance with paper diaries and actual compliance with paper diaries ( defined by comparing the written times and the electronically-recorded times of diary use ) . Actual compliance was recorded by the electronic diary . Participants su bmi tted diary cards corresponding to 90 % of assigned times ( + /-15 min ) . However , electronic records indicated that actual compliance was only 11 % , indicating a high level of faked compliance . On 32 % of all study days the paper diary binder was not opened , yet reported compliance for these days exceeded 90 % . For the electronic diary , the actual compliance rate was 94 % . In summary , participants with chronic pain enrolled in a study for research were not compliant with paper diaries but were compliant with an electronic diary with enhanced compliance features . The findings call into question the use of paper diaries and suggest that electronic diaries with compliance-enhancing features are a more effective way of collecting diary information 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 The Internet is used to deliver information on many psychiatric disorders such as bipolar disorder . This paper reports on the results of a 12-months r and omised controlled trial , which examined the efficacy of an Internet-based preventive program for bipolar disorder , adjunctive to usual pharmacological management . METHODS Participants were recruited by completing an online screening question naire accessed through the Black Dog Institute and Sentiens websites based in Australia . The treatment was predominantly psycho-educational with cognitive behavioral therapy optional elements . The attention control treatment comprised directing subjects to a variety of websites focused on ' healthy living ' . Time to recurrence was determined using Kaplan-Meier survival analysis . The main outcome measures were recurrence as defined by : ( i ) depressive and /or hypomanic symptomatology and functional capacity ( using Beck Depression Inventory , Internal State Scale and Sheehan Disability Scale ) and ( ii ) hospitalization . RESULTS Two-hundred- and -thirty-three subjects were r and omized to the active or control treatment groups . There were no significant differences between the active and control treatment groups on any of the definitions of recurrence . LIMITATIONS Reliance on an online self-report tool to confirm diagnosis and hospitalization rates may have potentially allowed for inclusion of individuals with other diagnoses such as borderline personality disorder . The ' attention control ' treatment may have included more ' active ' components than intended . CONCLUSIONS This is the first report examining the efficacy of a r and omized controlled web-based psychological intervention in a large sample of subjects with bipolar disorder . The potential reasons for failing to demonstrate a significant difference compared to the active control are discussed 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 The NIMH-Stanley Foundation Bipolar Treatment Outcome Network , a multisite clinical trials network , has been established to address many of the neglected areas of research in bipolar illness . The Network was design ed so that it would be able to conduct r and omized clinical trials at several different levels of method ologic rigor ( blinded and open-label ) both in academic and community practice setting s in order to better assess long-term efficacy of existing treatments and develop new ones . In this fashion , large numbers of representative patients with bipolar disorder have been enrolled with an additional focus of elucidating possible clinical and biological predictors of treatment response . The unique focus of the Network is its systematic longitudinal approach to illness so that patients can be assessed comprehensively over the long-term in sequential r and omized clinical trials at critical clinical decision points where data on relative efficacy are inadequate . Bipolar I and bipolar II patients with a range of illness variants and comorbidities are included . Daily prospect i ve ratings of severity of mania and depression and associated degree of functional impairment are completed on the NIMH-Life Chart Method and a modified Clinical Global Impressions Scale for Bipolar Illness ( CGI-BP ) is utilized . More detailed cross-sectional ratings for depression ( Inventory of Depressive Symptomatology ) , mania ( Young Mania Rating Scale ) , and psychosis ( Positive and Negative Syndrome Scale ) are additionally used at academic centers . This article describes the rationale for the Network , its guiding principles , methods , and study design to systematic ally assess the highly variable course of bipolar illness and its response to current and future treatments 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 We describe the development process and completed structure , of a self-help online intervention for bipolar disorder , known as MoodSwings ( www.moodswings.net.au ) . The MoodSwings program was adapted as an Internet intervention from an efficacious and vali date d face-to-face , group-based psychosocial intervention . The adaptation was created by a psychologist , who had previously been involved with the validation of the face-to-face program , in collaboration with website design ers . The project was conducted under the supervision of a team of clinician research ers . The website is available at no cost to registered participants . Self-help modules are accessed sequentially . Other features include a mood diary and a moderated discussion board . There has been an average of 1,475,135 hits on the site annually ( 2008 and 2009 ) , with some 7400 unique visitors each year . A r and omised controlled trial based on this program has been completed . Many people with bipolar disorder are accepting of the Internet as a source of treatment and , once engaged , show acceptable retention rates . The Internet appears to be a viable means of delivering psychosocial self-help strategies BACKGROUND Bipolar Disorder ( BD ) is a severe mental health problem . Psychological interventions are recommended by the National Institute for Health and Care Excellence ( NICE ) but patients experience severe inequalities in access . This study assessed the feasibility and potential effectiveness of a recovery informed web-based self-management intervention for people with BD . METHODS An online r and omised controlled trial ( n=122 ) compared  treatment as usual ( TAU ) plus the ' Living with Bipolar ' ( LWB ) intervention with a waiting list control ( WLC ) group .  RESULTS The study recruited to target and the retention rates were high . Participants engaged with the approach . Compared with the WLC , those receiving LWB showed the most robust improvement in psychological and physical domains of quality of life , wellbeing and recovery at the end of the intervention . LIMITATIONS The trial was not definitive and requires further investigation . CONCLUSIONS There is preliminary evidence that a web-based treatment approach in BD is feasible and potentially effective . Such interventions could form part of the Improving Access to Psychological Therapy ( IAPT ) initiative in severe mental health BACKGROUND Clinical insight in bipolar disorder is associated with treatment adherence and psychosocial outcome . The short-term dynamics of clinical insight in relationship to symptoms and cognitive abilities are unknown . METHODS In a prospect i ve observational study , a total of 106 out patients with bipolar disorder I or II were assessed at baseline , 6 weeks , 12 weeks , and 26 weeks . Participants were administered a comprehensive neuropsychological battery , clinical ratings of manic and depressive symptom severity , and self-reported clinical insight . Lagged correlations and linear mixed-effects models were used to determine the temporal associations between symptoms and insight , as well as the moderating influence of global cognitive abilities . RESULTS At baseline , insight was modestly correlated with severity of manic symptoms , but not with depressive symptoms or cognitive abilities . Insight and depressive symptoms fluctuated to approximately the same extent over time . Both lagged correlations and mixed effects models with lagged effects indicated that the severity of manic symptoms predicted worse insight at later assessment s , whereas the converse was not significant . There were no direct or moderating influences of global cognitive abilities . LIMITATIONS Our sample size was modest , and included relatively psychiatrically stable out patients , followed for a six month period . Our results may not generalize to acutely symptomatic patients followed over a longer period . CONCLUSIONS Clinical insight varies substantially over time within patients with bipolar disorder . Impaired insight in bipolar disorder is more likely to follow than to precede manic symptoms
target: 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: 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 .