Relapse Prevention In Bipolar Disorder Research Articles

Delphi Based Consensus by developing Relapse Prevention for Bipolar Disorder

Delphi Based Consensus by developing Relapse Prevention for Bipolar Disorder

The mediating role of self-compassion in the relationship between internalized stigma and psychological resilience in bipolar disorder.

Internalized stigma is known to be high in bipolar disorder (BD). Concepts such as self-compassion and psychological resilience have recently begun to be studied as protective factors for BD. The aim of the current study was to examine the relationships between internalized stigma, self-compassion and resilience among individuals with BD. One hundred and thirty-two male and female (18-65 years of age) participants with a DSM 5 diagnosis of BD (BD- I & BD- II) were included. The remission criteria (YMRS< 5 and HDRS< 7) was evaluated using clinician-administered measures and all participants were found to be remitted. Correlation and mediation analyses were performed. Participants completed the Internalized Stigma in Mental Illness Scale (ISMI), the Self-Compassion Scale (SCS) and the Resilience Scale for Adults (RSA). Significant correlations were found between internalized stigma, sub-dimensions of self-compassion (self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identification), and resilience in the expected directions like negative correlations between internalized stigma and positive dimensions of self-compassion (self-kindness, common humanity and mindfulness). Self-judgement and self-kindness mediated the relationship between internalized stigma and psychological resilience. The findings of the study shed light on which dimensions of self-compassion might be more beneficial to work with in order to increase resilience when working with internalized stigma in BD. This strengths-based investigation would be valuable to enrich psycho-social interventions for the prevention of relapse in BD.

Monotherapy vs. combination therapy for post mania maintenance treatment: A population based cohort study

In recent years, the use of atypical antipsychotics and combination therapy for relapse prevention in bipolar disorder has increased substantially. However, real-world data on the comparative effectiveness of these treatment options are largely non-existent. We conducted a population-based cohort study, using data from Swedish national registers. All patients aged 18–75 years who were hospitalized for mania 2006–2014 and filled at least one prescription of lithium, valproate, olanzapine, quetiapine, aripiprazole or any combination of these drugs were included, and followed for up to one year after hospital discharge, generating follow-up data from 5 713 hospitalizations. We used Cox proportional hazard regression models to study time to treatment failure for each individual drug and combination therapy, using lithium as comparator. Treatment failure was defined as treatment discontinuation, switch, or rehospitalization, and the results were adjusted for clinical and sociodemographic factors. We found that treatment failure occurred in 85% of cases and that the majority of combination therapies were associated with lower risks of treatment failure compared to monotherapies. Patients combining lithium + valproate + quetiapine had the lowest risk of treatment failure (adjusted HR [AHR] 0.40, 95% CI 0.30–0.54), followed by patients on lithium + valproate + olanzapine (AHR 0.55, 95% CI 0.45–0.68). In contrast, monotherapies with antipsychotics were associated with significantly higher risks of treatment failure compared to single use of lithium. In conclusion, our results support experimental findings, suggesting that combination therapy is more effective than monotherapy after a manic episode.

Timing of onset of lithium relapse prevention in bipolar disorder: evidence from randomised trials.

Lithium is widely prescribed, but the timing of key effects remains uncertain. The timing of onset of its relapse prevention effects is clarified by placebo-controlled randomised trials (3 studies, n = 1120). Lithium reduced relapse into any mood episode over the first 2 weeks of treatment (hazard ratio 0.40, 95% CI 0.16-0.97). Fewer manic relapses were evident within the first 4 weeks, however, early effects on depressive relapse were not demonstrated. There is an early onset of lithium relapse prevention effects in bipolar disorder, particularly against manic relapse. Full effects against depressive relapse may develop over a longer period.Declaration of interestM.J.T. reports personal fees from Sunovion, Otsuka, Lundbeck, outside the submitted work.

Assessing Feasibility and Acceptability of Web-Based Enhanced Relapse Prevention for Bipolar Disorder (ERPonline): A Randomized Controlled Trial.

BackgroundInterventions that teach people with bipolar disorder (BD) to recognize and respond to early warning signs (EWS) of relapse are recommended but implementation in clinical practice is poor.ObjectivesThe objective of this study was to test the feasibility and acceptability of a randomized controlled trial (RCT) to evaluate a Web-based enhanced relapse prevention intervention (ERPonline) and to report preliminary evidence of effectiveness.MethodsA single-blind, parallel, primarily online RCT (n=96) over 48 weeks comparing ERPonline plus usual treatment with “waitlist (WL) control” plus usual treatment for people with BD recruited through National Health Services (NHSs), voluntary organizations, and media. Randomization was independent, minimized on number of previous episodes (<8, 8-20, 21+). Primary outcomes were recruitment and retention rates, levels of intervention use, adverse events, and participant feedback. Process and clinical outcomes were assessed by telephone and Web and compared using linear models with intention-to-treat analysis.ResultsA total of 280 people registered interest online, from which 96 met inclusion criteria, consented, and were randomized (49 to WL, 47 to ERPonline) over 17 months, with 80% retention in telephone and online follow-up at all time points, except at week 48 (76%). Acceptability was high for both ERPonline and trial methods. ERPonline cost approximately £19,340 to create, and £2176 per year to host and maintain the site. Qualitative data highlighted the importance of the relationship that the users have with Web-based interventions. Differences between the group means suggested that access to ERPonline was associated with: a more positive model of BD at 24 weeks (10.70, 95% CI 0.90 to 20.5) and 48 weeks (13.1, 95% CI 2.44 to 23.93); increased monitoring of EWS of depression at 48 weeks (−1.39, 95% CI −2.61 to −0.163) and of hypomania at 24 weeks (−1.72, 95% CI −2.98 to −0.47) and 48 weeks (−1.61, 95% CI −2.92 to −0.30), compared with WL. There was no evidence of impact of ERPonline on clinical outcomes or medication adherence, but relapse rates across both arms were low (15%) and the sample remained high functioning throughout. One person died by suicide before randomization and 5 people in ERPonline and 6 in WL reported ideas of suicide or self-harm. None were deemed study related by an independent Trial Steering Committee (TSC).ConclusionsERPonline offers a cheap accessible option for people seeking ongoing support following successful treatment. However, given high functioning and low relapse rates in this study, testing clinical effectiveness for this population would require very large sample sizes. Building in human support to use ERPonline should be considered.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 56908625; http://www.isrctn.com/ISRCTN56908625 (Archived by WebCite at http://www.webcitation.org/6of1ON2S0)

Early onset of lithium relapse prevention in bipolar disorder

Early onset of lithium relapse prevention in bipolar disorder

Feasibility and acceptability of web-based enhanced relapse prevention for bipolar disorder (ERPonline): Trial protocol

BackgroundRelapse 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/designThis protocol describes the development and feasibility testing of the ERPonline web-based intervention using a single blind randomised 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 understanding 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. DiscussionThe 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 designed to support people with mental health problems.

Psychoeducation for relapse prevention in bipolar disorder: a systematic review of efficacy in randomized controlled trials.

Previous reviews have concluded that interventions including psychoeducation are effective in preventing relapse in bipolar disorder, but the efficacy of psychoeducation itself has not been systematically reviewed. Our aim was to evaluate the efficacy of psychoeducation for bipolar disorder in preventing relapse and other outcomes, and to identify factors that relate to clinical outcomes. We employed the systematic review of randomized controlled trials of psychoeducation in participants with bipolar disorder not in an acute illness episode, compared with treatment-as-usual, and placebo or active interventions. Pooled odds ratios (ORs) for non-relapse into any episode, mania/hypomania, and depression were calculated using an intent-to-treat (ITT) analysis, assigning dropouts to relapse, with a sensitivity analysis in which dropouts were assigned to non-relapse (optimistic ITT). Sixteen studies were included, eight of which provided data on relapse. Although heterogeneity in the data warrants caution, psychoeducation appeared to be effective in preventing any relapse [n = 7; OR: 1.98-2.75; number needed to treat (NNT): 5-7, depending on the method of analysis] and manic/hypomanic relapse (n = 8; OR: 1.68-2.52; NNT: 6-8), but not depressive relapse. Group, but not individually, delivered interventions were effective against both poles of relapse; the duration of follow-up and hours of therapy explained some of the heterogeneity. Psychoeducation improved medication adherence and short-term knowledge about medication. No consistent effects on mood symptoms, quality of life, or functioning were found. Group psychoeducation appears to be effective in preventing relapse in bipolar disorder, with less evidence for individually delivered interventions. Better understanding of mediating mechanisms is needed to optimize efficacy and personalize treatment.

EPA-0989 – Cost-effectiveness of atypical antipsychotics (quetiapine, risperidone, aripiprazole or olanzapine) for the treatment of relapse prevention for bipolar disorder in russian federation

To estimate the efficiency of the atypical antipsychotics (quetiapine, risperidone, aripiprazole or olanzapine) used to reduce relapses in bipolar disorder, taking into account costs and effectiveness (QALY). The Russian health care system perspective and a five year temporal horizon have been used. An annual discount rate assumed was of 5%. Taking into account the last literature review on bipolar disorder, four fundamental aspects related with bipolar disorder management were analyzed: relapse rates, inpatient treatment, outpatient treatment and hospitalization rates. The health care direct costs corresponding to the drug acquisition costs have been analyzed together with the costs of inpatient diagnostics, costs of inpatient treatment and costs of hospitality relapses updated with data from Russian health care system. Quetiapine or risperidone treatment presents the lower total costs (€13 562 and €13 097 respectively) versus the other strategies (aripiprazole = €36 328 and olanzapine = €19 957). Quetiapine presents the higher QALY compared with the alternatives (quetiapine = 3.551, risperidone = 3.534, aripiprazole = 3.528 and olanzapine = 3.525). With these results one can emphasize that quetiapine or risperidone treatment is dominant with the cost-effectiveness ratio (CER) of 3 819 and 3 706, respectively, versus aripiprazole or olanzapine groups (CER 10 297 and 5 662 respectively). The incremental CER (quetiapine vs. risperidone) is €27 322 per QALY. The results illustrate that quetiapine is dominant versus aripiprazole or olanzapine. Also quetiapine therapy is within willingness to pay threshold in case of risperidone substitution in Russian patients with bipolar disorder

PMH39 - Cost-effectiveness of atypical antipsychotics for the treatment of relapse prevention for bipolar disorder: The russian perspective

PMH39 - Cost-effectiveness of atypical antipsychotics for the treatment of relapse prevention for bipolar disorder: The russian perspective

Characterizing relapse prevention in bipolar disorder with adjunctive ziprasidone: Clinical and methodological implications

Ziprasidone, adjunctive to either lithium or valproate, has previously been shown to be associated with a significantly lower risk of relapse in bipolar disorder compared with lithium or valproate treatment alone. This placebo-controlled outpatient trial with ziprasidone adjunctive to lithium or valproate or lithium and valproate alone, for subjects with a recent or current manic or mixed episode of bipolar I disorder, comprised a 2.5- to 4-month, open-label stabilization period, followed by a 6-month, double-blind maintenance period. These post hoc analyses characterize the relapse outcomes by dose, relapse types and timing as well as all-reason discontinuations during the maintenance period. Time to relapse and all-reason discontinuation were both statistically significant in favor of the ziprasidone 120mg/day group compared with placebo (p=0.004 and 0.001, respectively) during the 6-month double-blind period. There was no difference in time to relapse in the 80 and 160mg/day dose groups compared with placebo (p=0.16 and 0.40, respectively) and, likewise, for time to all-reason discontinuation (p=0.20 for both doses). The majority of relapses in each group occurred prior to week 8, and most were depressive in nature. The primary study was not designed to compare relapse rates by dose groups. These analyses confirm the effectiveness of ziprasidone (80-160mg/day) in preventing relapses in subjects with bipolar disorder, with the 120mg/day dosage appearing to have the highest relapse prevention rate.

Involving relatives in relapse prevention for bipolar disorder: a multi-perspective qualitative study of value and barriers

BackgroundManaging early warning signs is an effective approach to preventing relapse in bipolar disorder. Involving relatives in relapse prevention has been shown to maximize the effectiveness of this approach. However, family-focused intervention research has typically used expert therapists, who are rarely available within routine clinical services. It remains unknown what issues exist when involving relatives in relapse prevention planning delivered by community mental health case managers. This study explored the value and barriers of involving relatives in relapse prevention from the perspectives of service users, relatives and care-coordinators.MethodsQualitative interview study nested within a randomized controlled trial of relapse prevention for individuals with bipolar disorder. The purposive sample of 52 participants comprised service users (n = 21), care coordinators (n = 21) and relatives (n = 10). Data were analyzed using a grounded theory approach.ResultsAll parties identified benefits of involving relatives in relapse prevention: improved understanding of bipolar disorder; relatives gaining a role in illness management; and improved relationships between each party. Nevertheless, relatives were often discouraged from becoming involved. Some staff perceived involving relatives increased the complexity of their own role and workload, and some service users valued the exclusivity of their relationship with their care-coordinator and prioritized taking individual responsibility for their illness over the benefits of involving their relatives. Barriers were heightened when family relationships were poor.ConclusionsWhilst involving relatives in relapse prevention has perceived value, it can increase the complexity of managing bipolar disorder for each party. In order to fully realize the benefits of involving relatives in relapse prevention, additional training and support for community care coordinators is needed.Trial registrationISRCTN41352631

Training in relapse prevention for bipolar disorder shows promise

Training in relapse prevention for bipolar disorder shows promise

Enhanced relapse prevention for bipolar disorder by community mental health teams: cluster feasibility randomised trial

Relapse prevention for bipolar disorder increases time to relapse but is not available in routine practice. To determine the feasibility and effectiveness of training community mental health teams (CMHTs) to deliver enhanced relapse prevention. In a cluster randomised controlled trial, CMHT workers were allocated to receive 12 h training in enhanced relapse prevention to offer to people with bipolar disorder or to continue giving treatment as usual. The primary outcome was time to relapse and the secondary outcome was functioning. Twenty-three CMHTs and 96 service users took part. Compared with treatment as usual, enhanced relapse prevention increased median time to the next bipolar episode by 8.5 weeks (hazard ratio 0.79, 95% CI 0.45-1.38). Social and occupational functioning improved with the intervention (regression coefficient 0.68, 95% CI 0.05-1.32). The clustering effect was negligible but imprecise (intracluster correlation coefficient 0.0001, 95% CI 0.0000-0.5142). Training care coordinators to offer enhanced relapse prevention for bipolar disorder may be a feasible effective treatment. Large-scale cluster trials are needed.

Training Staff in Enhanced Relapse Prevention for Bipolar Disorder: Rates of Uptake and Measures of Skill and Confidence

This study examined the feasibility and effectiveness of training clinical staff in enhanced relapse prevention for people with bipolar disorder in routine services. A cluster randomized controlled trial was conducted in North West England. This brief report focuses on the 56 staff who received enhanced relapse prevention. Staff-perceived skill in working with people with bipolar disorder to prevent relapse was assessed pretraining, posttraining, and postsupervision. Staff ratings of confidence and trainer ratings of competence for key elements of enhanced relapse prevention were made posttraining and postsupervision. Staff gave feedback on training and supervision. Feedback was very positive. Staff's perception of their skill increased after training and increased further after supervision. Most staff felt confident and were rated as competent in key elements of enhanced relapse prevention after training and supervision. An effective training and supervision package was developed. Barriers to implementation need to be addressed.

Training Staff in Enhanced Relapse Prevention for Bipolar Disorder: Rates of Uptake and Measures of Skill and Confidence

Training Staff in Enhanced Relapse Prevention for Bipolar Disorder: Rates of Uptake and Measures of Skill and Confidence

Enhanced relapse prevention for bipolar disorder: a qualitative investigation of value perceived for service users and care coordinators

BackgroundEnhanced relapse prevention (ERP) is a psychological intervention delivered by mental health professionals to help individuals with bipolar disorder (BD) recognise and manage early warning signs for mania and depression. ERP has an emerging evidence base and is recommended as good practice for mental health professionals. However, without highly perceived value to both those receiving (services users) or delivering it (health professionals), implementation will not occur. The aim of this study is to determine what values of ERP are perceived by service users (SUs) and mental health professionals (care coordinators, CCs) providing community case management.MethodsA nested qualitative study design was employed as part of a randomised controlled trial of ERP. Semi-structured interviews were conducted with a purposive sub-sample of 21 CCs and 21 SUs, and an iterative approach used to develop a framework of conceptual categories that was applied systematically to the data.ResultsThe process of implementing and receiving ERP was valued by both SUs and CCs for three similar sets of reasons: improved understanding of BD (where a knowledge deficit of BD was perceived), enhanced working relationships, and improved ways of managing the condition. There were some differences in the implications these had for both CCs and SUs who also held some reservations.ConclusionCCs and SUs perceive similar value in early warning signs interventions to prevent relapse, and these have particular benefits to them. If this perceived value is maintained, CCs and SUs in routine practice may use ERP long-term.

Six-Month Prospective Life Charting of Mood Symptoms with Lamotrigine Monotherapy Versus Placebo in Rapid Cycling Bipolar Disorder

Fluctuations in mood are quintessential features of bipolar disorder; however, previous studies have seldom examined the extent to which pharmacotherapies for bipolar disorder may reduce or ameliorate daily or weekly mood variability. The anticonvulsant lamotrigine has demonstrated efficacy for relapse prevention in bipolar disorder, but its possible mood-stabilizing properties on a day-to-day or week-to-week basis have not previously been investigated. Weekly mood shifts were examined over 26 weeks using patients' self-reported prospective Life Chart Method (LCM) data obtained as part of a previously reported randomized relapse prevention comparison of lamotrigine monotherapy or placebo in 182 bipolar patients with DSM-IV rapid cycling. Generalized estimating equation (GEE) analyses were used to compare treatment arms for subjects who achieved euthymia across weeks. After adjusting for potential confounding factors, a final GEE model revealed that subjects taking lamotrigine were 1.8 times more likely than those taking placebo to achieve euthymia, as measured by LCM, at least once per week over 6 months (95% confidence interval [CI] = 1.03-3.13). Subjects taking lamotrigine had an increase of .69 more days per week euthymic as compared with those taking placebo (p = .014). Achievement of euthymia across weeks represents a novel paradigm shift in gauging the mood-stabilizing properties of a psychotropic agent. The present findings demonstrate the utility of the prospective Life Chart Method for assessing longitudinal mood stability during randomized clinical trials for bipolar disorder. The results lend support to the potential mood-stabilizing properties of lamotrigine monotherapy for bipolar disorder.

Under‐recruitment of patients for clinical trials: an illustrative example of a failed study

Under‐recruitment of patients for clinical trials: an illustrative example of a failed study

Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder

BackgroundBipolar Disorder (BD) is a common and severe form of mental illness characterised by repeated relapses of mania or depression. Pharmacotherapy is the main treatment currently offered, but this has only limited effectiveness. A recent Cochrane review has reported that adding psycho-social interventions that train people to recognise and manage the early warning signs of their relapses is effective in increasing time to recurrence, improving social functioning and in reducing hospitalisations. However, the review also highlights the difficulties in offering these interventions within standard mental health services due to the need for highly trained therapists and extensive input of time. There is a need to explore the potential for developing Early Warning Sign (EWS) interventions in ways that will enhance dissemination.Methods and designThis article describes a cluster-randomised trial to assess the feasibility of training care coordinators (CCs) in community mental health teams (CMHTs) to offer Enhanced Relapse Prevention (ERP) to people with Bipolar Disorder. CMHTs in the North West of England are randomised to either receive training in ERP and to offer this to their clients, or to continue to offer treatment as usual (TAU). The main aims of the study are (1) to determine the acceptability of the intervention, training and outcome measures (2) to assess the feasibility of the design as measured by rates of recruitment, retention, attendance and direct feedback from participants (3) to estimate the design effect of clustering for key outcome variables (4) to estimate the effect size of the impact of the intervention on outcome. In this paper we provide a rationale for the study design, briefly outline the ERP intervention, and describe in detail the study protocol.DiscussionThis information will be useful to researchers attempting to carry out similar feasibility assessments of clinical effectiveness trials and in particular cluster randomised controlled trials.