human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 
    Output:
    
agent
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 .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 
    Output:
    