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Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol.

ABSTRACT: BACKGROUND:The primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (? 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support. METHODS/DESIGN:This international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored. DISCUSSION:This definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action. TRIAL REGISTRATION:ClinicalTrials.gov : NCT03197974 . Registered 23 June 2017.

SUBMITTER: Fletcher K

PROVIDER: S-EPMC6044003 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol.

Fletcher Kathryn K Foley Fiona F Thomas Neil N Michalak Erin E Berk Lesley L Berk Michael M Bowe Steve S Cotton Sue S Engel Lidia L Johnson Sheri L SL Jones Steven S Kyrios Michael M Lapsley Sara S Mihalopoulos Cathrine C Perich Tania T Murray Greg G

BMC psychiatry 20180713 1

<h4>Background</h4>The primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (≥ 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation ...[more]

PMID: 30001704

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Project description:BACKGROUND:Quality of life (QoL) is considered a key treatment outcome in bipolar disorder (BD) across research, clinical, and self-management contexts. Web-based assessment of patient-reported outcomes offer numerous pragmatic benefits but require validation to ensure measurement equivalency. A web-based version of the Quality of Life in Bipolar Disorder (QoL.BD) questionnaire was developed (QoL Tool). OBJECTIVE:This study aimed to evaluate the psychometric properties of a web-based QoL self-report questionnaire for BD (QoL Tool). Key aims were to (1) characterize the QoL of the sample using the QoL Tool, (2) evaluate the internal consistency of the web-based measure, and (3) determine whether the factor structure of the original version of the QoL.BD instrument was replicated in the web-based instrument. METHODS:Community-based participatory research methods were used to inform the development of a web-based adaptation of the QoL.BD instrument. Individuals with BD who registered for an account with the QoL Tool were able to opt in to sharing their data for research purposes. The distribution of scores and internal consistency estimates, as indicated by Cronbach alpha, were inspected. An exploratory factor analysis using maximum likelihood and oblique rotation was conducted. Inspection of the scree plot, eigenvalues, and minimum average partial correlation were used to determine the optimal factor structure to extract. RESULTS:A total of 498 people with BD (349/498, 70.1% female; mean age 39.64, SD 12.54 years; 181/498, 36.3% BD type I; 195/498, 39.2% BD type II) consented to sharing their QoL Tool data for the present study. Mean scores across the 14 QoL Tool domains were, in general, significantly lower than that of the original QoL.BD validation sample. Reliability estimates for QoL Tool domains were comparable with that observed for the QoL.BD instrument (Cronbach alpha=.70-.93). Exploratory factor analysis supported the extraction of an 11-factor model, with item loadings consistent with the factor structure suggested by the original study. Findings for the sleep and physical domains differed from the original study, with this analysis suggesting one shared latent construct. CONCLUSIONS:The psychometric properties of the web-based QoL Tool are largely concordant with the original pen-and-paper QoL.BD, although some minor differences in the structure of the sleep and physical domains were observed. Despite this small variation from the factor structure identified in the QoL.BD instrument, the latent factor structure of the QoL Tool largely reproduced the original findings and theoretical structure of QoL areas relevant to people with BD. These findings underscore the research and clinical utility of this instrument, but further comparison of the psychometric properties of the QoL Tool relative to the QoL.BD instrument is warranted. Future adaptations of the QoL Tool, including the production of an app-based version of the QoL Tool, are also discussed.

Project description:BackgroundAtypical antipsychotics are increasingly used for treatment of mental illnesses like schizophrenia and bipolar disorder, and considered to have fewer extrapyramidal effects than older antipsychotics.MethodsWe examined efficacy in randomised trials of bipolar disorder where the presenting episode was either depression, or manic/mixed, comparing atypical antipsychotic with placebo or active comparator, examined withdrawals for any cause, or due to lack of efficacy or adverse events, and combined all phases for adverse event analysis. Studies were found through systematic search (PubMed, EMBASE, Cochrane Library), and data combined for analysis where there was clinical homogeneity, with a special reference to trial duration.ResultsIn five trials (2,206 patients) participants presented with a depressive episode, and in 25 trials (6,174 patients) the presenting episode was manic or mixed. In 8-week studies presenting with depression, quetiapine and olanzapine produced significantly better rates of response and symptomatic remission than placebo, with NNTs of 5-6, but more adverse event withdrawals (NNH 12). With mania or mixed presentation atypical antipsychotics produced significantly better rates of response and symptomatic remission than placebo, with NNTs of about 5 up to six weeks, and 4 at 6-12 weeks, but more adverse event withdrawals (NNH of about 22) in studies of 6-12 weeks. In comparisons with established treatments, atypical antipsychotics had similar efficacy, but significantly fewer adverse event withdrawals (NNT to prevent one withdrawal about 10). In maintenance trials atypical antipsychotics had significantly fewer relapses to depression or mania than placebo or active comparator. In placebo-controlled trials, atypical antipsychotics were associated with higher rates of weight gain of >or=7% (mainly olanzapine trials), somnolence, and extrapyramidal symptoms. In active controlled trials, atypical antipsychotics were associated with lower rates of extrapyramidal symptoms, but higher rates of weight gain and somnolence.ConclusionAtypical antipsychotics are effective in treating both phases of bipolar disorder compared with placebo, and as effective as established drug therapies. Atypical antipsychotics produce fewer extrapyramidal symptoms, but weight gain is more common (with olanzapine). There is insufficient data confidently to distinguish between different atypical antipsychotics.

Project description:BACKGROUND:Bipolar disorder (BD) is a complex, relapsing mood disorder characterized by considerable morbidity and mortality. Web-based self-management interventions provide marked opportunities for several chronic mental health conditions. However, Web-based self-management programs targeting BD are underrepresented compared with programs targeting other psychiatric conditions. OBJECTIVE:This paper aims at facilitating future research in the area of self-management of BD and draws insights from the development of one such intervention-the Online, Recovery-Oriented Bipolar Individualised Tool (ORBIT)-that is aimed at improving the quality of life of people with BD. METHODS:We have discussed the opportunities and challenges in developing an engaging, evidence-based, safe intervention within the context of the following three nested domains: (1) intervention development; (2) scientific testing of the intervention; and (3) ethical framework including risk management. RESULTS:We gained the following insights across the three abovementioned overlapping domains: Web-based interventions can be optimized through (1) codesign with consumers with lived experience to ensure relevance and appropriateness to the target audience; (2) novel content development processes that iteratively combine evidence-based information with lived experience perspectives, capitalizing on multimedia (eg, videos) that the digital health space provides; and (3) incorporating Web-based communities to connect end users and promote constructive engagement by access to a Web-based coach. CONCLUSIONS:Self-management is effective in BD, even for those on the more severe end of the spectrum. While there are challenges to be aware of, guided self-management programs, such as those offered by the ORBIT project, which are specifically developed for Web-based delivery provide highly accessible, engaging, and potentially provocative treatments for chronically ill populations who may otherwise have never engaged with treatment. Key questions about engagement, effectiveness, and cost-effectiveness will be answered by the ORBIT project over the next 18 months.

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Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol.

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Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol.

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