title: Internet-based psychoeducation for bipolar disorder: a qualitative analysis of feasibility, acceptability and impact 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 Using Internet and Mobile Phone Technology to Deliver an Automated Physical Activity Program: Randomized Controlled 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. The evaluation of the results of clinical trials: surrogate end points and composite end points. A Text Message–Based Intervention for Weight Loss: Randomized Controlled Trial Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods 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. Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment Online mindfulness-based intervention for late-stage bipolar disorder: pilot evidence for feasibility and effectiveness. State-related differences in heart rate variability in bipolar disorder. Augmenting psychoeducation with a mobile intervention for bipolar disorder: a randomized controlled trial. Effects of adjunctive peer support on perceptions of illness control and understanding in an online psychoeducation program for bipolar disorder: a randomised controlled trial. A web-based preventive intervention program for bipolar disorder: outcome of a 12-months randomized controlled trial. A Tailored Web-Based Psychoeducational Intervention for Cancer Patients and Their Family Caregivers The sleep of remitted bipolar outpatients: a controlled naturalistic study using actigraphy. Better reporting of randomised controlled trials: the CONSORT statement A web-based self-management intervention for Bipolar Disorder 'living with bipolar': a feasibility randomised controlled trial. An online recovery plan program: can peer coaching increase participation?
abstract: Background In a recent exploratory r and omised trial we found that a novel , internet-based psychoeducation programme for bipolar disorder ( Beating Bipolar ) was relatively easy to deliver and had a modest effect on psychological quality of life . We sought to explore the experiences of participants with respect to feasibility , acceptability and impact of Beating Bipolar . Methods Participants were invited to take part in a semi-structured interview . Thematic analysis techniques were employed ; to explore and describe participants ’ experiences , the data were analysed for emerging themes which were identified and coded . Results The programme was feasible to deliver and acceptable to participants where they felt comfortable using a computer . It was found to impact upon insight into illness , health behaviour , personal routines and positive attitudes towards medication . Many participants regarded the programme as likely to be most beneficial for those recently diagnosed . Conclusions An online psychoeducation package for bipolar disorder , such as Beating Bipolar , is feasible and acceptable to patients , has a positive impact on self-management behaviours and may be particularly suited to early intervention . Alternative ( non-internet ) formats should also be made available to patients 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 Background The Internet has potential as a medium for health behavior change programs , but no controlled studies have yet evaluated the impact of a fully automated physical activity intervention over several months with real-time objective feedback from a monitor . Objective The aim was to evaluate the impact of a physical activity program based on the Internet and mobile phone technology provided to individuals for 9 weeks . Methods A single-center , r and omized , stratified controlled trial was conducted from September to December 2005 in Bedfordshire , United Kingdom , with 77 healthy adults whose mean age was 40.4 years ( SD = 7.6 ) and mean body mass index was 26.3 ( SD = 3.4 ) . Participants were r and omized to a test group that had access to an Internet and mobile phone – based physical activity program  ( n = 47 ) or to a control group ( n = 30 ) that  received no support . The test group received tailored solutions for perceived barriers , a schedule to plan weekly exercise sessions with mobile phone and email reminders , a message board to share their experiences with others , and feedback on their level of physical activity . Both groups were issued a wrist-worn accelerometer to monitor their level of physical activity ;  only the test group received real-time feedback via the Internet . The main outcome measures were accelerometer data and self-report of physical activity . Results At the end of the study period , the test group reported a significantly greater increase over baseline than did the control group for perceived control ( P < .001 ) and intention/expectation to exercise ( P < .001 ) . Intent-to-treat analyses of both the accelerometer data ( P = .02 ) and leisure time self-report data ( P = .03 ) found a higher level of moderate physical activity in the test group . The average increase ( over the control group ) in accelerometer-measured moderate physical activity was 2 h 18 min per week . The test group also lost more percent body fat than the control group ( test group : −2.18 , SD = 0.59 ; control group : −0.17 , SD = 0.81 ; P = .04 ) . Conclusions A fully automated Internet and mobile phone – based motivation and action support system can significantly increase and maintain the level of physical activity in healthy adults 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 The evaluation of the clinical outcome of patients enrolled in r and omised controlled studies should always be accurate and objective . The methods used to assess and report patients ' results must consequently be indicated a priori in the design of the clinical experimentation . Major ( hard ) individual end points currently constitute the gold st and ard in the definition of outcome measures , yet surrogate and composite end points are spreading diffusely as alternative/complementary outcome measures . Surrogate end points are minor outcome measures that are easier to record and are being adopted instead of major end points . They may be considered acceptable substitutes of hard end points when capable of predicting major events reliably , and when it may be demonstrated that the intervention on such surrogate end points consistently modifies the incidence of the event . In other cases they can not represent predictive elements of major clinical outcomes . Composite ( combined ) primary end points may contribute to improve the statistical precision of a clinical trial ; moreover , since clinical trials are particularly expensive , their identification permits more limited sample s of patients to be enrolled . Their limits include the possibility that the direction in which the different outcome measures composing the combined end point are modified is not the same . Biomedical research ers are called upon to design studies adopting major ( hard ) end points , rather than solitary surrogate end points , in order to provide really useful information for the care of patients . The selection of composite end points requires notable method ological attention so as to retrieve the most reliable estimates on the efficacy and the effectiveness of treatments Background To our knowledge , no studies have evaluated whether weight loss can be promoted in overweight adults through the use of an intervention that is largely based on daily SMS ( Short Message Service : text ) and MMS ( Multimedia Message Service : small picture ) messages transmitted via mobile phones . Objective This paper describes the development and evaluation of a text message – based intervention design ed to help individuals lose or maintain weight over 4 months . Methods The study was a r and omized controlled trial , with participants being exposed to one of the following two conditions , lasting 16 weeks : ( 1 ) receipt of monthly printed material s about weight control ; ( 2 ) an intervention that included personalized SMS and MMS messages sent two to five times daily , printed material s , and brief monthly phone calls from a health counselor . The primary outcome was weight at the end of the intervention . A mixed-model repeated- measures analysis compared the effect of the intervention group to the comparison group on weight status over the 4-month intervention period . Analysis of covariance ( ANCOVA ) models examined weight change between baseline and 4 months after adjusting for baseline weight , sex , and age . Results A total of 75 overweight men and women were r and omized into one of the two groups , and 65 signed the consent form , completed the baseline question naire , and were included in the analysis . At the end of 4 months , the intervention group ( n = 33 ) lost more weight than the comparison group ( −1.97 kg difference , 95 % CI −0.34 to −3.60 kg , P = .02 ) after adjusting for sex and age . Intervention participants ’ adjusted average weight loss was 2.88 kg ( 3.16 % ) . At the end of the study , 22 of 24 ( 92 % ) intervention participants stated that they would recommend the intervention for weight control to friends and family . Conclusions Text messages might prove to be a productive channel of communication to promote behaviors that support weight loss in overweight adults . Trial Registration Clinical trials.gov NCT00415870 ; http:// clinical trials.gov/ct2/show/NCT00415870 ( Archived by WebCite at http://www.webcitation.org/5dnolbkFt Background Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes , but delivery on a wide scale and at low cost is challenging . Some trials evaluating clinical interventions using short message service ( SMS ) text-messaging systems have shown important outcomes , although evidence is limited . We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-re source setting . We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care . Methods / design The SMS Text-message Adherence suppoRt trial ( StAR ) is a pragmatic individually r and omised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town , South Africa . The intervention is a structured programme of clinic appointment , medication pick-up reminders , medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages . Usual care is supplemented by infrequent non-hypertension related SMS text-messages . Participants are 1:1:1 individually r and omised , to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender , age , baseline systolic blood pressure , years with hypertension , and previous clinic attendance . The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation . Secondary outcomes include the proportion of patients with 80 % or more of days medication available , proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg , hospital admissions , health status , retention in clinical care , satisfaction with treatment and care , and patient related quality of life . Anonymised demographic data are collected on non- participants . Discussion The StAR trial uses a novel , low cost system based on widely available mobile phone technology to deliver the SMS-based intervention , manage communication with patients , and measure clinical ly relevant outcomes . The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-re source setting .Trial registration Background R and omized controlled trials ( RCTs ) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes . However , with a prolonged duration from recruitment to publication , high-cost trial implementation , and a rigid trial protocol , RCTs are perceived as an impractical evaluation methodology for most mHealth apps . Objective Given the recent development of alternative evaluation method ologies and tools to automate mHealth research , we sought to determine the breadth of these methods and the extent that they were being used in clinical trials . Methods We conducted a review of the Clinical Trials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015 . Results Of the 137 trials identified , 71 were found to meet inclusion criteria . The majority used a r and omized controlled trial design ( 80 % , 57/71 ) . Study design s included 36 two-group pretest-posttest control group comparisons ( 51 % , 36/71 ) , 16 posttest-only control group comparisons ( 23 % , 16/71 ) , 7 one-group pretest-posttest design s ( 10 % , 7/71 ) , 2 one-shot case study design s ( 3 % , 2/71 ) , and 2 static-group comparisons ( 3 % , 2/71 ) . A total of 17 trials included a qualitative component to their methodology ( 24 % , 17/71 ) . Complete trial data collection required 20 months on average to complete ( mean 21 , SD 12 ) . For trials with a total duration of 2 years or more ( 31 % , 22/71 ) , the average time from recruitment to complete data collection ( mean 35 months , SD 10 ) was 2 years longer than the average time required to collect primary data ( mean 11 , SD 8) . Trials had a moderate sample size of 112 participants . Two trials were conducted online ( 3 % , 2/71 ) and 7 trials collected data continuously ( 10 % , 7/68 ) . Onsite study implementation was heavily favored ( 97 % , 69/71 ) . Trials with four data collection points had a longer study duration than trials with two data collection points : F4,56=3.2 , P=.021 , η2=0.18 . Single-blinded trials had a longer data collection period compared to open trials : F2,58=3.8 , P=.028 , η2=0.12 . Academic sponsorship was the most common form of trial funding ( 73 % , 52/71 ) . Trials with academic sponsorship had a longer study duration compared to industry sponsorship : F2,61=3.7 , P=.030 , η2=0.11 . Combined , data collection frequency , study masking , sample size , and study sponsorship accounted for 32.6 % of the variance in study duration : F4,55=6.6 , P<.01 , adjusted r2=.33 . Only 7 trials had been completed at the time this retrospective review was conducted ( 10 % , 7/71 ) . Conclusions mHealth evaluation methodology has not deviated from common methods , despite the need for more relevant and timely evaluations . There is a need for clinical evaluation to keep pace with the level of innovation of mHealth if it is to have meaningful impact in informing payers , providers , policy makers , and patients 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 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 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 Heart rate variability ( HRV ) is a vali date d measure of sympato-vagal balance in the autonomic nervous system . HRV appears decreased in patients with bipolar disorder ( BD ) compared with healthy individuals , but the extent of state-related alterations has been sparingly investigated . The present study examined differences in HRV between affective states in BD . A heart rate and movement sensor weighing 8 g collected average acceleration , heart rate and the two slowest and fastest heart beats ( of the most recent 16 beats ) every 30 s over a period of at least three consecutive weekdays and nights in a prospect i ve longitudinal design from a total of 31 different affective states in 16 out patients with BD . A proxy measure of HRV was calculated as the difference between the second-shortest and the second-longest inter-beat-interval collected during each of the epochs . Analyses were based on over 100.000 HRV data -points . In unadjusted analyses and in analyses adjusted for age , gender and heart rate , during a manic state HRV was increased by 18 % compared with a depressed state ( eB = 1.18 , 95 % CI : 1.16 - 1.20 , p < 0.001 ) and increased by 17 % compared with a euthymic state ( eB = 1.17 , 95 % CI : 1.15 - 1.19 , p < 0.001 ) , whereas there was no difference between a depressive state and a euthymic state ( eB = 0.98 , 95 % CI : 0.96 - 1.00 , p = 0.12 ) . Further inclusion of BMI as a covariate did not alter any of the associations . HRV appears to be altered in a state-dependent manner in bipolar disorder and could represent a c and i date state marker . Further studies with larger sample sizes are warranted 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 OBJECTIVES To examine the comparative effectiveness of an online psychoeducation program for people diagnosed with bipolar disorder within the previous 12 months , completed alone or with adjunctive peer support , on symptoms and perceived control over the illness . METHOD Participants were r and omly allocated to an eight-week online psychoeducation program ( n=139 )  , a psychoeducation program plus online peer support ( n=134 ) or an attentional control condition ( n=134 ) . RESULTS Increased perceptions of control , decreased perceptions of stigmatisation and significant improvements in levels of anxiety and depression , from pre- to post-intervention were found across all groups . There were no significant differences between groups on outcome measures , although a small clinical difference was found between the supported and unsupported conditions in depression symptoms and in functional impairment at the six-month follow-up . Adherence to the treatment program was significantly higher in the supported intervention than in the unsupported program . Gender and age were also significant predictors of adherence , with females and those over the age of 30 showing greater adherence . LIMITATIONS Mood state at study entry was measured by self-report rather than by clinical interview . CONCLUSIONS The pattern of outcomes suggests a primary influence of non-specific or common therapeutic factors across all three intervention groups . A personally tailored intervention may be more suitable for individuals recently diagnosed with bipolar disorder , and longer term coaching may increase program adherence and long-term improvement in symptoms and functioning 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 : Most programs addressing psychosocial concerns of cancer survivors are in-person programs that are expensive to deliver , have limited availability , and seldom deal with caregivers ’ concerns . Objective : This study examined the feasibility of translating an efficacious nurse-delivered program ( FOCUS Program ) for patients and their caregivers to a tailored , dyadic Web-based format . Specific aims were to ( 1 ) test the preliminary effects of the Web-based intervention on patient and caregiver outcomes , ( 2 ) examine participants ’ program satisfaction , and ( 3 ) determine the feasibility of using a Web-based delivery format . Methods : A phase 2 feasibility study was conducted with cancer patients ( lung , breast , colorectal , prostate ) and their family caregivers ( N = 38 dyads ) . The Web-based intervention provided information and support tailored to the unique characteristics of each patient , caregiver , and their dyadic relationship . Primary outcomes were emotional distress and quality of life . Secondary outcomes were benefits of illness/caregiving , communication , support , and self-efficacy . Analyses included descriptive statistics and repeated- measures analysis of variance . Results : Dyads had a significant decrease in emotional distress , increase in quality of life , and perceived more benefits of illness/caregiving . Caregivers also had significant improvement in self-efficacy . There were no changes in communication . Participants were satisfied with program usability , but recommended additional content . Conclusions : It was possible to translate a clinician-delivered program to a Web-based format that was easy to use and had positive effects on dyadic outcomes . Implication s for Practice : The Web-based program is a promising way to provide psychosocial care to more patients and caregivers using fewer personnel . It needs further testing in a larger r and omized clinical trial BACKGROUND Several sleep laboratory studies suggest sleep abnormalities in bipolar disorder . However , this is the first study to compare remitted bipolar subjects with controls on actigraphic and subjective sleep parameters in a naturalistic setting over 5 nights . METHODS Nineteen subjects with Bipolar I Disorder and 19 age- and gender-matched healthy controls were included . Objective  sleep parameters  were estimated using wrist actigraphs .  Subject-rated sleep diaries and mood ratings were also completed . Sleep data were averaged for each subject across nights , and raw score st and ard deviations were calculated as a measure of within-subject variability . RESULTS Multivariate analyses of variance found significant group differences for both actigraphic ( F(4,33)=3.80 , P=0.012 ) and subjective measures ( F(4,31)=3.18 , P=0.027 ) . Univariate analyses identified reliable differences in sleep onset latency ( subjective ) , sleep duration ( subjective ) , and variability of sleep duration and night wake time ( actigraphic ) . Binary backward stepwise logistic regression demonstrated that a combination of three sleep measures correctly predicted disorder status in 84 % of cases . LIMITATIONS Failure to match on sociodemographic and employment status is a limitation that may provide an alternative explanation for some findings . Furthermore , in the bipolar group 18 of 19 subjects were in receipt of psychotropic medication , compared to none of the healthy control group . Also , no information was recorded about family history of mental disorders in the control group . CONCLUSIONS The study suggests that the sleep of remitted bipolar out patients measured in naturalistic setting s is characteristically different from controls : bipolar subjects sleep longer , report longer onset latencies , and display greater variability across nights R and omised controlled trials are the best way to compare the effectiveness of different interventions . Only r and omised trials allow valid inferences of cause and effect . Only r and omised trials have the potential directly to affect patient care — occasionally as single trials but more often as the body of evidence from several trials , whether or not combined formally by meta- analysis . It is thus entirely reasonable to require higher st and ards for papers reporting r and omised trials than those describing other types of study . Like all studies , r and omised trials are open to bias if done badly.1 It is thus essential that r and omised trials are done well and reported adequately . Readers should not have to infer what was probably done , they should be told explicitly . Proper methodology should be used and be seen to have been used . Yet review s of published trials have consistently found major deficiencies in reporting,2 3 4 making the task 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 OBJECTIVE A pilot study evaluated whether the addition of online coaching from a peer specialist increased participation in an online program featuring educational and interactive modules to promote self-management of bipolar disorder . METHODS A total of 118 participants with bipolar disorder recruited from online and in-person support groups and clinical setting s were enrolled in MyRecoveryPlan . Half the group was r and omly assigned to receive online coaching support from a certified peer specialist . RESULTS Participants offered online peer coaching were more likely to return to the program after registration ( 71 % versus 44 % , p=.005 ) and to continue using the program after three weeks ( 38 % versus 9 % , p<.001 ) . This pattern was consistent for all program elements . CONCLUSIONS The addition of online coaching from a peer specialist significantly increased engagement and retention in the program , but further research is needed to evaluate the program 's effects on clinical and recovery outcomes
target: Taken together , the literature presented in this dissertation illustrates that 1 ) smartphone-based electronic self-monitoring of mood  seems to reflect clinical ly assessed depressive and manic symptoms and enables the long-term characterization of mood instability in bipolar disorder ; 2 ) preliminary results suggest that smartphone-based automatically generated data ( e.g. the number of text messages sent/day ; the number of incoming and outgoing calls/day ; the number of changes in cell tower IDs/day ; and voice features ) seem to reflect clinical ly assessed depressive and manic symptoms in bipolar disorder ; 3 ) smartphone-based electronic self-monitoring had no effects on the severity of depressive and manic symptoms in bipolar disorder , according to a r and omized controlled trial ; and 4 ) electronic  monitoring of psychomotor activity and heart rate variability seems to reflect illness activity in bipolar disorder and differentiate between patients with bipolar disorder and healthy control individuals .
  These findings point toward the usefulness of  electronic monitoring  as a marker of illness in bipolar disorder .
background: Major reasons for the insufficient effects of current treatment options in bipolar disorder include delayed intervention for prodromal depressive and manic symptoms and decreased adherence to psychopharmacological treatment .
  The reliance on subjective information and clinical evaluations when diagnosing and assessing the severity of depressive and manic symptoms calls for less biased and more objective markers .
  By using electronic devices , fine-grained data on complex psychopathological aspects of bipolar disorder can be evaluated unobtrusively over the long term .
  Using electronic monitoring as a treatment intervention could provide innovative and novel interventions on-dem and with a potential global reach , filling the gap between availability and the need for treatment .