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A Study of the Real-World Effectiveness of Group Psychoeducation for Bipolar Disorders: Is Change in Illness Perception a Key Mediator of Benefit?
Abstract
Background:
Findings from efficacy trials of group psychoeducation (PE) for bipolar disorders (BD) led to its inclusion in evidence-based guidelines as a first-line mandatory treatment. However, pragmatic trials and observational studies are needed to determine its real-world effectiveness, impact on outcomes deemed important to patients and to clarify potential mediators of any benefits.
Methods:
Individuals with BD were offered the opportunity to participate in 20h of PE and asked to complete pre- and post-intervention ratings of symptoms, knowledge about BD, medication adherence, and illness perception. A priori, two key patient outcomes were identified (social functioning and self-esteem); sample attrition due to dropout or relapse was recorded.
Results:
Of 156 individuals who completed the pre-PE assessments, 103 completed the program and post-PE assessments. Only 4 of 53 dropouts were associated with BD relapse. Post-intervention, the PE completers demonstrated a statistically significant improvement in social functioning (p = 0.003, Effect Size (ES) = 0.26) and a trend towards improved self-esteem (ES = 0.14). Whilst there were significant changes in medication adherence (p = 0.002, ES = 0.28), knowledge of BD (p < 0.001, ES = 1.20), and illness perception (p < 0.001, ES = -0.37), mediational analysis demonstrated that only change in illness perception was associated to change in functioning (p=0.03) with no contribution from changes in knowledge of BD or medication adherence.
Conclusions:
In real-world settings, over 60% individuals completed 10-session course of PE. After controlling for demography and baseline clinical state, change in illness perception, rather than change in knowledge or medication adherence, emerged as a potential mediator of some benefits of PE.
... These efficacy RCTs are very important and the eligibility criteria minimize confounding and biases (e.g., by recruiting homogeneous samples), which in turn maximizes opportunities to detect treatment effects. However, the consequences of this sampling strategy are the potential loss of external validity and generalizability (Scott 2008;Etain et al. 2018). This was demonstrated clearly by Hoertel et al. (2013) who reported that more than 50% individuals diagnosed with BD are excluded from these efficacy RCTs (58-64% for depression trials; 56% for hypo/mania trials). ...
... This was demonstrated clearly by Hoertel et al. (2013) who reported that more than 50% individuals diagnosed with BD are excluded from these efficacy RCTs (58-64% for depression trials; 56% for hypo/mania trials). The excluded cases were those that were least likely to respond to the experimental treatments or interventions, and/or were less likely to adhere with pharmacotherapy, meaning that there are several clinically relevant questions about the use of psychological interventions to improve outcomes (response or recovery) for individuals diagnosed with BD that still need to be addressed (Etain et al. 2018). For example, unresolved questions regarding the management of BD include how best to overcome BD depression and how to improve real world outcomes, given the high rates of suboptimal adherence with medications (McIntyre et al. 2020). ...
... It is possible to speculate that some of these individuals were ambivalent about (or even against) the use of pharmacotherapy but were more accepting of a psychological approach. Our dataset is too small to attempt mediation analyses, but it is reported that psychological interventions lead to improved medication adherence in individuals diagnosed with BD (Colom et al. 2003a, b;Etain et al. 2018). However, enhancing adherence does not fully account for the gains attributed to psychological interventions, and some but not all research demonstrates reductions in relapses in those receiving psychoeducation who are already highly adherent to medication (Colom et al. 2005;Morriss et al. 2016) and that change in attitudes towards BD and enhanced self-management may be as, if not more critical components (Miklowitz et al. 2021). ...
Abstract Background Efficacy trials of medications and/or psychological interventions for bipolar disorders (BD) aim to recruit homogenous samples of patients who are euthymic and such populations show high levels of adherence to the treatments offered. This study describes a secondary analysis of a large-scale multi-centre pragmatic effectiveness randomized controlled trial (RCT) of cognitive behaviour therapy plus treatment as usual (CBT) or treatment as usual alone (TAU) and explores outcomes in individuals who were: (i) recruited in depressive episodes, or (ii) receiving suboptimal doses of or no mood stabilizers (MS). Methods Data were extract on two separate subsamples (out of 253 RCT participants). Sample 1 comprised 67 individuals in a depressive episode (CBT: 34; TAU: 33); Sample 2 comprised 39 individuals receiving suboptimal MS treatment (CBT: 19; TAU: 20). Survival analyses (adjusted for confounding variables) were used to explore recovery in Sample 1 and relapse in Sample 2. Results In Sample 1 (individuals with depression), Cox proportional hazards regression model revealed that the median time to recovery was significantly shorter in the CBT group (10 weeks; 95% confidence intervals (CI) 8, 17) compared to the TAU group (17 weeks; 95% CI 9, 30) [Adjusted Hazard Ratio (HR) 1.89; 95% CI 1.04, 3.4; p
... Five studies have explored the relationship between treatment outcomes and illness representations in people with a bipolar disorder (Hou et al., 2010;Oflaz et al., 2015;Averous et al., 2018;Etain et al., 2018;M'Bailara et al., 2019). Good treatment adherence was predicted by high treatment control and low emotional representation (Averous et al., 2018). ...
... Dropout patients had higher emotional representations and personal control, and lower consequences, than adherent patients (Oflaz et al., 2015). Two studies have shown that after educational therapies, illness representations were improved (Etain et al., 2018;M'Bailara et al., 2019). ...
... Specifically, Marcus et al. (2014) recommend targeting illness perceptions (particularly controllability) in the early stages of cognitive behavioral therapy in order to improve engagement and, therefore, outcomes. To change illness representations, psychoeducation seems to be a promising intervention, increasing control and belief in the effectiveness of treatment, and reducing negative emotions about the disorder (Etain et al., 2018;M'Bailara et al., 2019). If one of the objectives of psychoeducation is to improve patients' knowledge, these authors specify that it is not the increase in knowledge as a result of psychoeducation that improves outcomes, but rather changes in illness representations. ...
Understanding and improving the psychosocial adjustments (e.g., quality of life, depression) and treatment outcomes (e.g., adherence, beliefs about treatments) of people with mental disorders are major health issues. The self-regulation model (SRM) postulates that illness representations play a central role on adjustment and treatment of people with physical illnesses. Recently, the SRM has been used with people with mental disorders. However, the manifestations of somatic and psychiatric disorders can be very different. Therefore, the use of SRM in the field of mental health is very complex. This difficulty, as well as the growing interest for illness representations in the field of mental health, justifies the utility to conduct a review on this topic. The current review shows that illness representations are related to psychosocial adjustment and/or treatment outcomes for people with various mental disorders [e.g., psychotic disorders, mood disorder, posttraumatic stress disorder (PTSD), attention deficit hyperactivity disorder (ADHD)]. However, some limitations to the applicability of SRM to mental disorders have been highlighted. These limitations should be considered in future studies.
... Camardese et al. (2018) found that a psychoeducational and psychological programme improved self-reported insight and resilience. Etain et al. (2018) ...
... They also show an increase in perceived ability to keep mood stable, take action to prevent relapse and greater awareness of early warning signs and triggers, in line with the work of de Andrés et al. (2006), who found that group therapy increase perceived ability to cope with relapse. Similarly Etain et al (2018) showed that improvements in functioning following psychoeducation were mediated by change in diagnosis perception. Experiencing symptoms was in the opposite direction to expected with individuals reporting more symptoms: this might represent becoming more aware of their earning warning signs as is one of the group aims. ...
... In particular there were no improvements on the Views on Manic Depression Scale which measures self-esteem and stigma in relation to Bipolar Disorder. This is surprising given that stigma has been shown to be less likely in those who F o r P e e r R e v i e w have received psychoeducation (Nilsson et al., 2016), and psychological and psychoeducational programmes have also been shown to improve self-esteem in Bipolar Disorder (Etain et al., 2018). The measure used has not been validated and though in this sample it had a high chronbach's alpha level it might not be a valid measure of Bipolar Disorder specific stigma. ...
Previous research has shown that psychoeducation for bipolar disorder (BD) improves symptoms and reduces relapse risk, but there is little research on how this impacts stigma, perceived recovery and views about diagnosis. The aim of this study was to explore whether a cognitive behaviour therapy (CBT)-based 12-week BD psychoeducation group conducted in a community mental health team for adults impacted perceived stigma, diagnosis-related self-esteem, recovery and views about diagnosis. The case series pre- and post-group had 23 participants across three groups. The Brief Illness Perception Questionnaire, views on Manic Depression Questionnaire, Bipolar Recovery Questionnaire and author-constructed questions were completed pre and post. Twenty participants completed the group. An intent-to-treat repeated measures multiple analysis of variance showed significantly improved perceived recovery and improvements in sense of control and understanding around their diagnosis. Other specific questions such as understanding of triggers and impact of thinking patterns also improved. However, there was no change in the perceived stigma or self-esteem associated with living with BD. CBT-based psychoeducation groups may help improve perceived recovery and factors such as sense of control in BD. However, there appears to be no impact on stigma and self-esteem, and the role of non-specific factors needs to be examined further.
Key learning aims
(1) To raise awareness of the impact of stigma and self-esteem in bipolar disorder.
(2) To understand the content and structure of CBT-based psychoeducation groups.
(3) To consider the potential benefits of CBT-based psychoeducation groups beyond symptoms and relapse reduction on factors such as perceived recovery.
... Il en résulte une diminution du risque de rechute et une réduction de la sévérité avec des rechutes moins intenses et moins longues [15][16][17][18][19]. La psychoéducation conduit aussi à moins d'hospitalisation après deux ans [17] et permet un maintien de l'effet à cinq ans [18], avec un effet sur les phases maniaques plus clair que sur les phases dépressives [20]. Enfin, elle améliore l'observance médicamenteuse [21,22]. Participer à de tels programmes est efficace tant pour les patients ayant un trouble bipolaire de type 1 [23], que de type 2 [24], que pour ceux ayant une comorbidité de trouble de personnalité [25]. ...
... Si l'effet positif de l'ETP sur l'autosoin est largement démontré, les effets sur les compétences d'adaptation psychosociale restent moins documentés par la littérature [47]. En effet, jusqu'alors les études avaient surtout montré l'intérêt de l'ETP concernant les prises de décisions du patient modifiant l'effet du trouble bipolaire sur sa santé [14][15][16][17][18][19][20][21][22]. Une des plus-values de notre étude est de montrer que les participants ont une perception moins menaç ante du trouble après avoir participé au groupe, ce qui pourrait favoriser l'acquisition de compétences d'adaptation psychosociale, seconde cible de l'ETP. ...
... Le travail autour des représentations est une cible thérapeutique au cours des ateliers. Ainsi, nos résultats s'inscrivent dans la lignée de travaux récents effectués auprès de patients qui montrent que seul le changement de perception de la maladie est associé au fonctionnement alors que la modification des connaissances n'impacte pas le fonctionnement psychosocial [22]. L'ETP des patients mais aussi des familles favorise l'acquisition de compétences d'adaptation psychosociale et ne peut être réduite à une dimension pédagogique qui consisterait uniquement en l'acquisition de connaissances. ...
Objectives: The patient with bipolar disorder and his family are caught in a reciprocal interaction: on one hand, the pathology leads to family sufferings and on the other hand, family behavior affects the disease of the patient and its development. Therefore, it seems of core importance that the psychologist should work with the family on their perception of bipolar disorder, that is to say, on their knowledge and psychological representations of the pathology. The aim of our study is to assess whether the initial perception of bipolar disorder evolves after a therapeutic education program. Method: Our research was conducted at the Bipolar Expertise Centre in Bordeaux/Centre Expert Bipolaire in Bordeaux on a sample of 145 participants (78patients and 67 family caregivers). They were all interviewed before and after the therapeutic education program (12 sessions in 6 months). The Brief Illness Perception Questionnaire Revised (Moss-Morris, 2002) measures the perception of bipolar disorder and the BP Quizz (Fondation Fondamental) assesses the degree of knowledge of the disorder. Results: Results show that therapeutic education helps families to level up their knowledge about bipolar disorder. Furthermore, representations on bipolar disorder have globally changed so that on average, bipolar disorder is viewed as less threatening by families after 12 sessions of therapeutic education. More precisely, after the program, families have a better understanding and a better insight of the disorder, which is then perceived as being less severe. On the emotional level, anxiety and stress have decreased. So there are an increase of knowledge and a change in perception. Conclusion: Our study shows that the therapeutic education program enables families to change their perception of the disease, that is to say, their knowledge but also their representations of the disease, which is a fundamental element according to the models of therapeutic education. Our results point out one of the active processes of therapeutic education at work in the sessions: in the perception of the disease, which is composed of both knowledge and representations of the disease, just a change in representations constitutes a lever for therapeutic education. Therefore, working on representations should be a therapeutic target. As a conclusion, we can say that therapeutic education of families cannot be reduced to an educational dimension which would only consist of gaining knowledge. Then, the right posture of the psychologist is to hold each participant's own development and changing process of representations.
... College is a time of transitioning away from home and family, often for the first time, and this transition often comes with hardship. Further, difficulties with this transition are compounded by the fact that the typical college years (ages [18][19][20][21][22] are also the most common ages for the onset of a variety of mental health disorders. 1 In a study by Auerbach et al, 2 one-third of college freshmen at 19 colleges across eight countries suffered from at least one DSM-IV anxiety, mood, or substance use disorder. ...
... These courses can help reduce stigma related to mental illness, as participants see that others deal with these issues, too, giving them the strong sense that they are not alone. 19 The context of these psychoeducation courses is also important in reducing stigma, as students are learning about mental illness and treatment in an academic setting. 20 This setting can highlight to students that mental health is as important as the other academic material required of them to graduate. ...
Objective:
This study examines the effects of a scalable psychoeducation intervention to improve students' mental health during the COVID-19 pandemic.
Participants:
In a sample of racially diverse undergraduates from a highly selective university (N = 66), students in the control group (mostly women) participated in courses as usual and students in the intervention group (only women) participated in a psychoeducation course on evidence-based strategies for coping, designed for college students living through the pandemic.
Methods:
Rates of psychological distress were measured through online surveys at baseline and follow-up assessments.
Results:
Students in both the intervention and control groups had clinically elevated depressive symptoms. Consistent with hypotheses, students in the intervention group had lower levels of academic distress and more positive perceptions regarding mental healthcare at the follow-up assessment than students in the control group. Contrary to hypotheses, students in both groups had similar levels of depressive symptoms, feelings of being overwhelmed, and coping. Preliminary findings suggest that the intervention primarily improved help-seeking and may have reduced stigma.
Conclusions:
Psychoeducation in an academic setting may be one means by which to decrease academic distress and reduce mental health stigma at highly selective institutions.
... [32,33] Similarly, researches from India reported improved self-esteem (P = 0.00) after group psychoeducation in bipolar patients. [34][35][36] The current study also revealed a marked reduction in caregivers' burden (P = 0.00). Similarly, Navidian reported a significant decrease in the mean score of Zarit burden interview (P = 0.00). ...
... When comparing 1 year before inclusion versus during the follow-up period, we observed significant decreases -above 50% -in the number of mood episodes, the number of hospitalizations and the duration of hospitalizations. The decrease in number of days being hospitalized during follow-up may be explained by a better adherence to medication (see paragraph below about trajectories of adherence), a better adequation with evidence-based medication regime (see section about psychotropic medications), but also by participation (at least for some individuals) to psychoeducation groups that are organized in each center (Etain et al., 2018). In addition, individuals showed a significant improvement in functioning, this improvement being associated with a reduction of mood symptoms and of active psychiatric comorbidities, an improvement of sleep quality and a better treatment adherence. ...
Background
The FACE-BD cohort is an observational cohort of individuals with bipolar disorders (BD) who benefited from a systematic evaluation with evidence-based treatment recommendations and who were followed-up every year for 3 years in France. The objectives were to describe the lifetime course of BD, associated psychiatric and somatic comorbidities, and cognition profile. This cohort aims to identify clinical/biological signatures of outcomes, trajectories of functioning and transition between clinical stages. This article summarizes 10 years of findings of the FACE-BD cohort.
Method & results
We included 4422 individuals, all having a baseline assessment, among which 61.2% had at least one follow-up visit at either one, two or three years. A subsample of 1200 individuals had at least one biological sample (serum, plasma, DNA). Assessments include family history of psychiatric disorders, psychiatric diagnosis, current mood symptoms, functioning, hospitalizations, suicidal attempts, physical health, routine blood tests, treatment history, psychological dimensions, medico-economic data and a cognitive assessment. Studies from this cohort illustrate that individuals with BD display multiple coexistent psychiatric associated conditions including sleep disturbances, anxiety disorders, substance use disorders and suicide attempts as well as a high prevalence of metabolic syndrome. During follow-up, we observed a 55% reduction of the number of days of hospitalization and a significant improvement in functioning.
Conclusions
The FACE-BD cohort provides a strong research infrastructure for clinical research in BD and has a unique position among international cohorts because of its comprehensive clinical assessment and sustainable funding from the French Ministry of Health.
... [32,33] Similarly, researches from India reported improved self-esteem (P = 0.00) after group psychoeducation in bipolar patients. [34][35][36] The current study also revealed a marked reduction in caregivers' burden (P = 0.00). Similarly, Navidian reported a significant decrease in the mean score of Zarit burden interview (P = 0.00). ...
Background:
Lack of awareness has alarmingly raised the proportion of drug noncompliance among psychiatric patients, which are proven worrisome not only to the patients but also to their caregivers. An individually tailored family psychoeducation will address the issue by enhancing the knowledge among patients and their caregivers.
Aim:
The aim of this study is to assess the efficacy of family psychoeducation on drug compliance, self-esteem, and caregiver's burden among psychotic and mood disorder patients in a selected tertiary care center, Uttarakhand, India.
Methods:
A quasi-experimental study was performed among 120 participants using total enumerative sampling in a general hospital psychiatric ward. Data were collected from patients and caregivers using the Medication Adherence Rating Scale, Rosenberg Self-esteem Scale, and Zarit burden interview-22. The outcome measures were evaluated in the 2 and 4th weeks, and data were analyzed using the descriptive (frequency, percentage) and inferential statistics (Friedman analysis of variance, Wilcoxon signed-rank test) using the SPSS software version 23.0.
Results:
The present study showed that almost 30% of patients were noncompliant with their drug regime (mean ± standard deviation, 4.23 ± 1.57), and a majority (63.33%) of them presented with a low level of self-esteem. Furthermore, 71.7% and 13.3% of caregivers experienced a moderate and severe burden. An increase in drug compliance (35%) and self-esteem (31%) and a decrease in caregivers' burden (13%) were observed after the administration of family psychoeducation (P = 0.00).
Conclusion:
There is a great need to provide family psychoeducation on a routine basis in general hospitals. Patients with higher self-esteem will ultimately show improved social and occupational functionality resulting in satisfactory treatment compliance and decreased caregivers' burden.
... The scarce service evaluations of group therapy for BAD that have been published are psychoeducation or mixed-model treatment groups, but not CBT-G (Etain et al., 2018). Therefore, this study's primary objective is to evaluate the effectiveness of CBT-G for BAD within an adult CMHT. ...
Background
Previous systematic reviews have demonstrated efficacy of Cognitive Behavioural Therapy Groups (CBT-G) in treating bipolar affective disorder (BAD). However, effectiveness research of BAD CBT-G (groups delivered in clinical practice rather than a research trial) is sparse. Additionally, the efficacy literature shows variation in the number of sessions delivered, and the number needed for clinically significant change is unclear. Therefore, we examine the effectiveness of a 12-week CBT-G compared to an 8-week group.
Methods
An 8-week vs 12-week CBT-G was delivered in routine practice in an adult community mental health team. We compared pre-post data for N=88 participants with a diagnosis of BAD who attended either an 8-week CBT-G (n=43) or 12-week CBT-G (n=45).
Results
All routine outcome measure scores which included measures related to depression, generalised anxiety, psychological distress and functioning improved significantly from baseline to treatment endpoint for both the 8-week and 12-week CBT-G interventions, with no significant differences between the groups at post-treatment.
Limitations
No measure for manic symptoms was included. No follow-up data was collected. The study lacks a comparator control group.
Conclusions
This research adds to the literature in two ways by: (i) demonstrating the effectiveness of CBT-G for bipolar affective disorder; (ii) being the first to show no significant difference in outcome measures between an 8-week and 12-week group. The findings can be used to inform the provision of both a clinical and cost-effective intervention.
... Their findings show that the construction of identity in BD is a transformative process, made of struggles and renegotiations. What is certain is that the diagnosis of BD often marks a disruption in the person's life that requires a renegotiation of identity, influenced by the sporadic and cyclical mood changes (Fernandez et al., 2014), that is important for recovery (Etain et al., 2018;Fernandez et al., 2014;Inder et al., 2008Inder et al., , 2011Mansell et al., 2010;Michalak et al., 2011;Rusner et al., 2009;Sajatovic et al., 2008;Tse et al., 2014). ...
Symptoms of borderline personality disorder (BPD) and bipolar disorder (BD) often overlap. In some cases, it is difficult to conduct a differential diagnosis based only on current diagnostic criteria Therefore, it is important to find clinical factors with high discriminatory specificity that, used together with structured or semi‐structured interviews, could help improve diagnostic practice.
We propose that a clinical analysis of identity, self‐concept and self‐esteem may help distinguish the two disorders, when they are not comorbid. Our review of the studies that analyze these constructs in BD and BPD, separately, points in the direction of qualitative differences between the two disorders. In BPD, there is a well‐documented identity diffusion and the self‐concept appears predominantly negative; shifts in self‐concept and self‐esteem are often tied to interpersonal triggers. In BD, patients struggle with their identity, but narrative identity might be less compromised compared to BPD; the shifts in self‐concept and self‐esteem appear more linked to internal (i.e. mood and motivational) factors. We end the paper by discussing the implications for clinicians and ideas for future comparative research.
... On the contrary, the literature concerning illness representations of patients with mental disorders is considerably smaller. Nevertheless, recently a growing number of studies investigate illness representations of persons with mental disorders, including schizophrenia and psychosis ( Cavelti et al., 2012 ;Gómez-de-Regil, 2015 ), bipolar disorder ( Averous et al., 2018 ;Etain et al., 2018 ), eating disorders ( Dovydaitiene and Maslauskiene, 2013 ), and depression ( Mc Sharry et al., 2015 ;Vollmann et al., 2010 ). ...
Purpose: Illness representations are key determinants of depressive symptoms in patients with mental and physical disorders. Leventhal's Common Sense Model (CSM) - the leading psychological model of self-regulation - is used to understand people's responses to illness. The CSM proposes a dynamic interaction between illness representations, self-management, and health outcomes. This systematic review is the first to examine the associations of the CSM's illness representations with clinical and treatment-related outcomes in patients with depression and to identify factors that mediate or moderate the aforementioned associations.
Methods: We carried out a comprehensive literature search on PubMed, ScienceDirect, PsycINFO, Scopus, Google Scholar, and Web of Science databases. Eleven studies investigating the association between illness representations and depression outcomes were identified.
Results: Negative representations of identity, control, consequences, coherence, and chronic timeline were associated with poorer depression outcomes, including higher severity of depression, higher anxiety level, poorer patient psychosocial functioning, and longer treatment duration. Furthermore, various beliefs about the causes of depression were differentially associated with outcome variables.
Limitations: The search was limited to English language and grey literature was not examined.
Conclusion: Having a thorough understanding of depression and appraising it as an acute and controllable illness, with a limited number of symptoms and consequences is associated with better outcomes, and an overall better illness experience. The findings of this review have the potential to inform clinical interventions in depression based on illness representations. Further research is required to establish causal relations between illness representations and depression outcomes.
... Thirteen out of 103 patients withdrew from the group sessions due to reasons other than recurrences; these patients had higher scores in the BRIAN indicating higher irregularity in their daily rhythms and routines which may, in some cases, affect the adherence to attending weekly sessions. A similar percentage of non-completers was reported in a recent study on group psychoeducation (Etain et al., 2018). From the 90 study completers, approximately half (52.2%) responded to psychoeducation, while the rest did not. ...
Background
: The efficacy of adjunctive group psychoeducation in bipolar disorder has been proven although treatment response differ among individuals. The aim of this study was to characterize responders and non-responders to group psychoeducation in order to identify baseline variables that could predict treatment response.
Methods
: The sample was composed of 103 medicated euthymic patients with bipolar disorder referred to 21 sessions of group psychoeducation (6 months). Sociodemographic and clinical variables, temperament, circadian rhythms, BDNF, cognitive and psychosocial functioning were collected. At the 18-month endpoint, the patients were split in two groups on the basis of having suffered any recurrence. Significant group differences were included in a logistic regression analysis.
Results
: Ninety patients out of 103 engaged in group psychoeducation, 47 of whom (52.2%) responded to psychoeducation and 43 (47.8%) did not. Recurrences occurred more often in the follow-up, the most common being depression. Responders and non-responders differed in gender, age at diagnosis, latency of diagnosis, temperament, attention composite score and BDNF. Lower age at diagnosis of bipolar disorder, lower cyclothimic temperament scores and being male -which was associated with bipolar type I and a trend to more previous manic episodes- were significantly related to a better response to psychoeducation in the regression analysis.
Limitations
: No control group.
Conclusions
: This study identifies age at diagnosis as a significant modifiable risk factor of treatment response, highlighting the need for early identification of bipolar disorder. Existing programs should be adjusted to the characteristics of specific subpopulations in the framework of a personalized approach.
... This is supported by a recent study indirectly which showed in a real world study, a group psychoeducation program in patients with bipolar disorder, multiple benefits resulted including improvement in illness perception, medication adherence, knowledge of the disease along with final improvements in social functioning and selfesteem. This improvement in functioning is mediated by improvement in illness perception only, rather than treatment adherence or knowledge [33] . Hence it is necessary to properly psycho-educate every carcinoma patient. ...
... An unclear understanding of disease identity, consequences, and treatment outcomes leads to anxiety and depression and consequently can worsen the disease (Bystryn and Rudolph, 2005). Furthermore, a correction of misconceptions about the disease may improve treatment outcomes (Chen et al., 2018;Etain et al., 2018;Keogh et al., 2011;Lee et al., 2018). ...
Objective
Little is known about illness perception in patients with pemphigus vulgaris (PV). We designed a cross-sectional study to clarify the beliefs about PV.
Methods
A total of 100 patients with PV (45 men, 55 women) completed the Illness Perception Questionnaire-Revised to assess beliefs about seven aspects of illness perception, including chronicity, recurrence, consequences, self and medicine role in controlling illness, coherence, and emotional representation. The relationship between illness perception and clinical and demographic variables was evaluated.
Results
Patients viewed PV as a chronic and cyclical disease with important impression on their life and emotions. Patients had a good understanding of the disease and supposed an acceptable role for themselves and medical treatment. Interestingly, the clinical subtype and severity of the disease did not influence any aspect of illness perception, but some differences on the basis of demographic data were demonstrated.
Conclusion
Our patients had a relatively good understanding of their illness and a correct perception about chronicity and the cyclical identity of illness. The patients believed that their life and emotions had been strongly influenced by the disease but were hopeful for a cure. Because correction of misconceptions about a disease may improve treatment outcomes, an assessment of patients' illness perception may be useful to try and modify perception.
... The best mood stabilizer to be chosen as the first choice in addition to a SGA-LAI is obviously lithium due to its well established clinical effectiveness [50][51][52]. Furthermore, it can be hypothesized that if patients decide to drop lithium treatment that is more than a remote possibility, especially in the long-term [53], the concomitant administration of a SGA-LAI may be their lifeline and may permit psychiatrist to re-evaluate its reintroduction or using patient-centred strategies (such as individual or group psychoeducation) in order to improve compliance when the patients come to our facilities to receive the injections [54][55][56]. ...
Bipolar Disorder (BD) is a severe, chronic and disabling condition. The gold standard of treatment is lithium, but the introduction of Second Generation Long-Acting Antipsychotics (SGA-LAIs) has been addressed several problems in the administration of oral SGAs in BD such as the patient’s adherence to the treatment. The aim of this commentary was to provide an overview of the use of SGA-LAIs in the treatment of BD. All considered, the use of SGA-LAIs such as Risperidone Long-Acting and Aripiprazole Long-Acting may have an important impact on the maintenance treatment of BD both in monotherapy or in association with mood stabilizers. In our opinion, the treatment with a SGA-LAI should be initiated as early as possible in BD, especially when non-adherence is suspected. Moreover, as personality disorders (PD) and BD may often coexist, it is worthy to note that the PD-BD comorbidity may further decrease treatment adherence and, therefore, we believe that the early use of a SGA-LAI both in monotherapy or in association with mood stabilizers may dramatically improve the compliance and the overall outcomes in such cases. However, he safety profile should be always kept in mind when choosing an SGA- LAI in the treatment of BD.
Objective
The efficacy of psychological interventions for bipolar disorder (BD) is well established, but much remains unknown about how change occurs. The primary objective of this exploratory study was to audit what is known about active components and mechanisms of action of psychological interventions for BD.
Method
We conducted a systematic review (PROSPERO CRD42022323276). Two independent reviewers screened references from four databases and extracted data from eligible studies.
Results
We included four component studies, six studies with mediation analyses and 26 studies presenting subjective experiences of how psychological interventions bring change. Ten mediators were examined across six studies, with only one putative mediator, medication adherence, tested in more than one study. Some initial support for mediation of varied outcomes by control over thoughts, positive non‐verbal behaviour, self‐esteem, post‐trauma growth and medication adherence. Some preliminary support was found in two components, human support and IPT. Studies exploring participant experiences of therapeutic change enumerated a range of potential active components, mechanisms of action and contextual factors potentially warranting investigation in future research. However, the evidence base for active components and mechanisms of action in psychological interventions for BD is unsatisfactory. Findings were inconsistent, studies homogenous with significant methodological limitations and statistical approaches failed to meet quality criteria.
Conclusions
Preliminary identification of potential components and mechanisms via qualitative analyses and the insights emerging from this review will inform future research aimed at investigating how psychological interventions work in BD.
Our study aims to examine the possible mediating effects of biological rhythms on the relationship between illness perception, cognitive flexibility, and functionality in bipolar patients in remission. A total of 150 patients with bipolar disorder (BD) were enrolled. The sociodemographic data form, Biological Rhythm Interview of Assessment in Neuropsychiatry (BRIAN), Brief Illness Perception Questionnaire (BIPQ), Cognitive Flexibility Scale (CFS), Young Mania Rating Scale, Montgomery and Asberg Depression Scale, Beck Anxiety Inventory, and Short Functionality Assessment Scale were applied to the patients in the study. The mean age of the patients was 42.10 ± 12.92 (SD). The participants were 48.7% (n = 73) female and 66.6% (n = 100) BD-I. There was a negative correlation between the total BRIAN score and favorable BIPQ scores and a positive correlation between the total BRIAN score and unfavorable BIPQ scores (except timeline). Additionally, multiple regression analyses revealed that the total BRIAN score could predict favorable BIPQ (except treatment control) and unfavorable BIPQ (except timeline) scores (p < 0.05). The total CFS score also could predict favorable BIPQ (treatment control) and unfavorable BIPQ scores (except timeline). The second step mediation analysis showed that biological rhythm mediated the relationship between illness perception and cognitive flexibility. Our study found that biological rhythms played a full mediating role in the relationship between the perception of illness and cognitive flexibility. In addition, worsening in biological rhythms in bipolar patients could cause negative beliefs and attitudes towards their diseases with an unfavorable clinical course. Therefore, regularity in biological rhythms should be highly recommended for bipolar patients.
Introduction
Suboptimal adherence is a well-established, pervasive problem in individuals with bipolar disorder (BD) causing disability, suffering, and cost.
Areas Covered
This review covers new research since January 2016 regarding internal (patient-centered) and external (system level) barriers and facilitators to adherence. Measures of adherence, the efficacy of psychosocial adherence enhancement interventions in individuals with BD, and, finally, novel delivery systems for BD medication are also covered. Measures of adherence continue to fall broadly into objective measures (i.e. drug levels) and more subjective, self-report measures and a combination of these likely provides the most comprehensive picture. Efficacious components of psychosocial adherence enhancement interventions include psychoeducation, motivational interviewing, and cognitive behavioral strategies, yet methods for delivery vary. Long-acting injectable (LAI) medications for BD are the drug delivery system with the most promise for BD. Combining psychosocial components with novel drug delivery systems has the potential for establishing and maintaining medication adherence.
Expert opinion
Psychosocial interventions improve adherence in individuals with BD. Psychoeducation is a necessary but not sufficient component in psychosocial interventions. LAIs should be considered earlier for adherence improvement than many treatment guidelines currently suggest. Comparative studies are lacking as is research into novel systems of medication delivery.
Background
Governments, private industries and not-for-profit organizations are increasingly investing resources in support programs for patients. These programs may provide self-management strategies enabling patients to manage their disease and medication regimen and/or access to medications, therapies and health services, with the goal to improve health outcomes. The objectives of this scoping review were to: (i) describe the characteristics of patient support programs (PSPs), for patients on medication regimens, (ii) identify subthemes that describe PSP services, and (iii) to classify the service subthemes, using an integrated people-centered (IP-C) perspective.
Methods
PRISMA-ScR methodology and Covidence software were used to facilitate the review of 479 articles, and the selection and screening of 70 original research articles that described PSP services and their impact on clinical, humanistic and/or economic outcomes. A search of PubMed, Embase, CINAHL, Academic Search Ultimate, and Web of Science was conducted covering a 10 year period, from 2010 to 2020. The PSPs identified were organized into subthemes identified as part of an inductive process. The thematic areas were grouped into one of three people-centered categories that reflect the WHO vision for IPC health care.
Results
The 70 articles reviewed, describe PSPs covering more than nine disease categories. The majority of the articles were published in North America, predominantly in the United States (26) and Canada (11), and also in Germany (6), the United Kingdom (6), China (4) and other countries (18). PSPs were funded and delivered by private drug or device manufacturers, government organizations, specialty pharmacies and also non-governmental groups (e.g., not-for-profit organizations), private hospitals, private payers (e.g., insurance companies) and various partnership types among these organizations. Fifty-six unique PSPs were identified that offered a range of services. Twenty-five PSP service subthemes were identified and these were each placed into one of three over-arching patient-centered categories: (i) access and equity services; (ii) quality and health services, and (iii) patient and caregiver empowerment and self-management services.
Conclusions
PSPs offer various services that can be optimized and synergized to facilitate equitable, accessible, quality health services that support patient empowerment for the self-management of disease for improved health outcomes.
L'observance thérapeutique des patients en psychiatrie - et plus particulièrement des malades souffrant de troubles bipolaires – est très souvent partielle. Celle-ci représente un véritable enjeu de santé publique car elle est responsable de nombreuses rechutes et de suicides. Ainsi, le retentissement de cette problématique d’observance est important aussi bien pour le patient, son entourage que pour la société. Dans ce travail de thèse, nous nous sommes intéressés aux nombreux facteurs qui affectent l'observance notamment au rôle de représentation sociale de la maladie en tant que déterminant à part entière de l’observance. En s’appuyant sur plusieurs théories et modèles portant sur l’observance, nous avons essayé de comprendre les déterminant du comportement "non observant" des patients afin d’envisager, in fine, des interventions psychothérapeutiques plus ciblées. Il s'agit par ailleurs dans ce travail de mettre en évidence la différence de perception en termes de représentation et d’objectifs thérapeutiques des différents protagonistes (médecins, patients, personnes tout-venants) face à la maladie. Nos résultats montrent l'existence d'une différence de perception et de représentation entre les soignants et les soignés mais aussi que l'observance est en lien direct avec l'alliance thérapeutique. En effet, plus l'alliance est élevée et meilleure est l'observance. En revanche, la représentation sociale de la maladie et du patient souffrant de trouble bipolaire est identique pour les personnes bipolaires et les non bipolaires et c'est le fait de se percevoir "malade "ou non qui influence l'observance. Le patient qui se perçoit comme « malade » sera plus enclin à se soigner qu'un patient qui ne ressent pas de trouble et aura donc une meilleure observance. Tenter de réduire cette différence de représentations sociales entre les médecins et les malades en travaillant en partenariat, en favorisant la pluridisciplinarité, en intégrant les nouvelles technologies et innovations médicales en matière de surveillance et de suivi, permettra certainement d'obtenir une meilleure prise en charge du malade et par conséquent une meilleure observance. La représentation sociale apparait donc, dans notre étude, comme un déterminant important de l'observance à prendre en compte pour améliorer la prise en charge globale du patient souffrant de trouble bipolaire.
Health beliefs, and especially illness representations, have been widely used to
understand clinical outcomes and psychosocial adjustment in people with physical
diseases. However, this area of research has been under-explored in the field of
mental health, and the few studies that have been conducted have used very different
methods. Therefore, the aim of our study was to identify the tools and methods that
have been used to evaluate illness representations in psychiatry. To this end, a mini
review has been conducted and 58 articles were retained. This mini review highlights
that the quantitative method is the most used, and that the scales mobilized are often
adapted for the study but not validated. Indeed, multiple modifications and adaptations
are made by the authors (e.g. deletion of subscales, addition of items), which leads to
questions about the reliability of what is measured. In the future, it is essential to have
a validated generic tool for mental disorders, which could be based on the Illness
Perceptions Questionnaire for Schizophrenia.
Background
The association between illness perceptions and the effectiveness of patients’ illness-management strategies has been supported across a range of medical and psychiatric disorders. Few studies have examined these variables or their association in bipolar disorder (BD). This study examined the main and interactive associations between illness perceptions and one important illness management strategy - social rhythms stability on mood symptom severity in adults with BD.
Methods
A cross-sectional study with 131 patients with BD in Taiwan was conducted using clinician- and patient-rated mood symptoms, self-reported illness perceptions, and a measure of daily and nightly social rhythms.
Results
Illness perceptions were associated with mood symptom severity, but social rhythms were not. Unfavorable illness perceptions (e.g., beliefs of experiencing more BD symptoms, having stronger emotional responses to the illness) were associated with more severe mood symptoms. Favorable illness perceptions (e.g., beliefs of being able to understand and control the illness) were associated with less severe mood symptoms, with personal control as the strongest correlate of mood symptom severity. Finally, social rhythm stability moderated the relationship between unfavorable illness perceptions and clinician-rated manic symptoms.
Limitations
The cross-sectional design limits our ability to make causal conclusions. Also, the effects pertain to patients in remission and may not generalize to more severely ill or hospitalized bipolar patients.
Conclusions
This study indicates that in patients with BD, illness perceptions are associated with symptom severity. Interventions to enhance favorable IPs and reduce unfavorable IPs may improve mood outcomes, particularly when patients have adopted regular social rhythms.
With vigorous researches related to novel treatment in psychiatric field, paradigm shift is emerging with its design and assessment. Comprehension of the psychiatric phenomenon expanded beyond disease model, with dimensional approach. Assessment of patients’ clinical state includes subjective reports related to problematic symptoms, functional change, and quality of life. They also include objective findings collected from mobile e-wearable monitoring system and advanced neuroimaging modalities. Novel treatment protocols are not just limited to pharmacology itself or psychotherapy itself, but the approach is integrated with stratification; pharmacological treatment enhanced by cognitive behavioral management and psychotherapeutic intervention has been emerged and studied for its impact. Numerous studies were conducted to understand placebo response and to differentiate this phenomenon with novel treatments. Trials to draw good adherence to research protocol with good compliance to treatment in real are strengthened by integrated approach, so-called psychopharmacology. With these paradigm shifts observed from recent researches, it is promising for great advance in quality of life and our mental health.
Background. Several previous studies have established that low treatment adherence is common among bipolar patients and may explain high rates of recurrence. On the other hand, some patients keep relapsing even when they strictly follow their prescribed somatic treatments. Psychological interventions such as psychoeducation may foster early recognition of prodromal symptoms and minimize the risk of relapse. To date, studies assessing the usefulness of psychoeducation in fully compliant patients are lacking. Method. This was a single-blind, randomized, prospective clinical trial on the efficacy of group psychoeducation in remitted fully compliant DSM-IV bipolar I patients (N = 25) who were compared with a group with similar characteristics (N = 25) who did not receive psychoeducation. All patients received naturalistic pharmacologic treatment. Recruitment began in 1997 and follow-up was completed in January 2002. The follow-up phase comprised 2 years during which all patients continued receiving naturalistic treatment without psychological intervention and were assessed monthly on several outcome measures. Results: At the end of the 2-year follow-up, 23 subjects (92%) in the control group fulfilled criteria for recurrence versus 15 patients (60%) in the psychoeducation group (p < .01). The number of total recurrences and the number of depressive episodes were significantly lower in psychoeducated patients. Conclusion: Although the present study has the limitation of small sample size, psychoeducation showed its efficacy in preventing relapses in bipolar I patients who were adherent to drug treatment. The action of psychoeducation seems to go beyond compliance enhancement and may support a tripod model composed by lifestyle regularity and healthy habits, early detection of prodromal signs followed by prompt drug intervention, and finally treatment compliance.
The discussion about the optimal design of clinical trials reflects the perspectives of theory-based scientists and practice-based clinicians. Scientists compare the theory with published results. They observe a continuum from explanatory to pragmatic trials. Clinicians compare the problem they want to solve by completing a clinical trial with the results they can read in the literature. They observe a mixture of what they want and what they get. None of them can solve the problem without the support of the other. Here, we summarize the results of discussions with scientists and clinicians. All participants were interested to understand and analyze the arguments of the other side. As a result of this process, we conclude that scientists tell what they see, a continuum from clear explanatory to clear pragmatic trials. Clinicians tell what they want to see, a clear explanatory trial to describe the expected effects under ideal study conditions and a clear pragmatic trial to describe the observed effects under real-world conditions. Following this discussion, the solution was not too difficult. When we accept what we see, we will not get what we want. If we discuss a necessary change of management, we will end up with the conclusion that two types of studies are necessary to demonstrate efficacy and effectiveness. Efficacy can be demonstrated in an explanatory, ie, a randomized controlled trial (RCT) completed under ideal study conditions. Effectiveness can be demonstrated in an observational, ie, a pragmatic controlled trial (PCT) completed under real-world conditions. It is impossible to design a trial which can detect efficacy and effectiveness simultaneously. The RCTs describe what we may expect in health care, while the PCTs describe what we really observe.
Background:
Prejudicial beliefs, emotions, and behaviours cause discrimination against people labeled as mentally ill. This stigmatization is sometimes internalized by the patients, leading to self-stigmatization. Specific features and impacts of stigmatization and self-stigmatization in patients with bipolar illness are the subjects of this review.
Method:
Studies were identified through PUBMED, Web of Science and Scopus databases as well as existing reviews. The search terms included "bipolar disorder", "stigma", "self-stigma" psychoeducation", "psychotherapy", "psychosocial treatment". Key articles listed in reference lists were searched.
Results:
Considerable recent evidence indicates that bipolar patients and their families are stigmatized, and that this stigmatization affects their quality of life as well as social functioning. The severity of stigmatization in bipolar disorder is greater than that in people with depression. There is also evidence of self-stigmatization which further decreases the quality of life. Stigmatization and self-stigmatization were shown to be one of the barriers that delay or prevent effective treatment, and thus exert adverse effects on the outcomes of bipolar disorder.
Conclusion:
Stigma affects the experience of illness as well as social functioning in patients with bipolar disorder. The impact of stigma on the lives and treatment outcomes of patients with bipolar disorder mandates intensive effort of mental health research and policy to address this problem. Much has been done against the stigmatization of the mentally ill. But the fight against stigma remains a fundamental objective of health programs for mental health.
Group psychoeducation is a cost effective intervention which reduces relapse and improves functioning in bipolar disorder but is rarely implemented. The aim of this study was to identify the acceptability and feasibility of a group psychoeducation programme delivered by community mental health teams (CMHTs) and peer specialist (PS) facilitators. Organisational learning was used to identify and address systematically barriers and enablers, at organisational, health professional and patient levels, to its implementation into a routine service.
A systematic examination of barriers and enablers to a three day training process informed the delivery of a first treatment group and a similar process informed the delivery of the second treatment group. Triangulation of research methods improved its internal validity: direct observation of training, self-rated surveys of participant experiences, group discussion, and thematically analysed individual participant and facilitator interviews were employed.
Barriers and enablers were identified at organisational, educational, treatment content, facilitator and patient levels. All barriers under the control of the research team were addressed with subsequent improvements in patient knowledge about the condition and about local service. In addition, self-management, agency and altruism were enhanced. Barriers that could not be addressed required senior clinical and education leadership outside the research team's control. PS and professional facilitators were successfully trained and worked together to deliver groups which were generally reported as being beneficial.
Psychoeducation groups involving CMHT and PS facilitators is acceptable and feasible but their sustainment requires senior leadership within and outside the organisation that control finance and education services.
A large body of comparative effectiveness research (CER) focuses on the use of observational and quasi-experimental approaches. We sought to examine the use of clinical trials as a tool for CER, particularly in mental health.
Examination of three ongoing randomized clinical trials in psychiatry addressing issues that would pose difficulties for nonexperimental CER methods.
Existing statistical approaches to nonexperimental data appear insufficient to compensate for biases that may arise when the pattern of missing data cannot be properly modeled such as when there are no standards for treatment, when affected populations have limited access to treatment, or when there are high rates of treatment dropout.
Clinical trials should retain an important role in CER, particularly in cases of high disorder prevalence, large expected effect sizes, difficult-to-reach populations, or when examining sequential treatments or stepped-care algorithms. Progress in CER on mental health will require careful consideration of appropriate selection between clinical trials and nonexperimental designs and on allocation of research resources to optimally inform key treatment decisions for each patient.
Background
Psychoeducation has been shown to reduce relapse rates in several psychiatric disorders. Studies investigating for which psychiatric diagnoses psychoeducation is offered and assessing its perceived relevance compared to other interventions are lacking.
Methods
A two-part questionnaire addressing these questions was sent to the heads of all psychiatric hospitals in Germany, Austria and Switzerland. Results were compared with those from a similar survey 5 years earlier.
Results
289 of 500 (58%) institutions responded. Significantly (p = 0,02) more institutions (93%) offer any type of psychoeducation as compared to 5 years before (86%). Psychoeducation is mainly offered for schizophrenia (86%) and depression (67%) and less frequently for anxiety disorders (18%) and substance abuse (17%). For the following specific diagnoses it is offered by less than 10% of the institutions: Personality disorder, bipolar disorder, posttraumatic stress disorder, dementia, obsessive compulsive disorder, sleeping disorders, eating disorders, schizophrenia plus substance abuse, pain, attention deficit hyperactivity disorder and early psychosis. 25% offer diagnosis-unspecific psychoeducation. ‘Pharmacotherapy’ (99%), ‘basic occupational therapy’ (95%) and ‘psychoeducation for patients’ (93%) were the therapies being most often, ‘light therapy’ (24%) and ‘sleep deprivation’ (16%) the therapies being least often perceived as relevant by the respondents when asked about the value of different interventions offered in their hospitals. Art therapy (61%) and psychoanalytically oriented psychotherapy (59%), two therapies with a smaller evidence base than light therapy or sleep deprivation, were perceived as relevant by more than the half of the respondents.
Conclusion
Psychoeducation for patients is considered relevant and offered frequently in German-speaking countries, however, mostly only for schizophrenia and depression. The ranking of the perceived relevance of different treatment options suggests that the evidence base is not considered crucial for determining their relevance.
OBJECTIVE The authors sought to assess the efficacy of functional remediation, a novel intervention program, on functional improvement in a sample of euthymic patients with bipolar disorder. METHOD In a multicenter, randomized, rater-blind clinical trial involving 239 outpatients with DSM-IV bipolar disorder, functional remediation (N=77) was compared with psychoeducation (N=82) and treatment as usual (N=80) over 21 weeks. Pharmacological treatment was kept stable in all three groups. The primary outcome measure was improvement in global psychosocial functioning, measured blindly as the mean change in score on the Functioning Assessment Short Test from baseline to endpoint. RESULTS At the end of the study, 183 patients completed the treatment phase. Repeated-measures analysis revealed significant functional improvement from baseline to endpoint over the 21 weeks of treatment (last observation carried forward), suggesting an interaction between treatment assignment and time. Tukey's post hoc tests revealed that functional remediation differed significantly from treatment as usual, but not from psychoeducation. CONCLUSIONS Functional remediation, a novel group intervention, showed efficacy in improving the functional outcome of a sample of euthymic bipolar patients as compared with treatment as usual.
Objective: To evaluate the efficacy of psychoeducation in the symptomatic and functional recovery, and quality of life (QoL) in a sample of patients with bipolar disorder (BD).
Method: The sample comprised 55 patients with BD I and II in remission (Young Mania Rating Scale ≤6 and Hamilton Depression Rating Scale ≤7). Out-patients were matched assigned to receive 16 sessions of psychoeducation [experimental group (EG)] or 16 sessions of placebo without psychoeducation [control group (CG)]. Groups were evaluated at study baseline, midpoint, endpoint, and at 6- and 12-month follow-ups.
Results: No significant differences between the groups were found for the variables evaluated (mood symptoms, functioning and QoL), except for overall clinical improvement, subjectively perceived by EG subjects. Both groups showed a trend toward improved clinical global impression and QoL (environmental). No reduction in mood symptoms or improvement in psychosocial functioning was observed. Psychosocial treatment compliance was positively correlated with global functioning, social adjustment, sociability, and global clinical impression.
Conclusion: Sixteen session psychoeducation seems to be ineffective to prevent mood episodes or improve functioning in a sample of bipolar patients.
The construction of a depression rating scale designed to be particularly sensitive to treatment effects is described. Ratings of 54 English and 52 Swedish patients on a 65 item comprehensive psychopathology scale were used to identify the 17 most commonly occurring symptoms in primary depressive illness in the combined sample. Ratings on these 17 items for 64 patients participating in studies of four different antidepressant drugs were used to create a depression scale consisting of the 10 items which showed the largest changes with treatment and the highest correlation to overall change. The inner-rater reliability of the new depression scale was high. Scores on the scale correlated significantly with scores on a standard rating scale for depression, the Hamilton Rating Scale (HRS), indicating its validity as a general severity estimate. Its capacity to differentiate between responders and non-responders to antidepressant treatment was better than the HRS, indicating greater sensitivity to change. The practical and ethical implications in terms of smaller sample sizes in clinical trials are discussed.
The common approach to the multiplicity problem calls for controlling the familywise error rate (FWER). This approach, though, has faults, and we point out a few. A different approach to problems of multiple significance testing is presented. It calls for controlling the expected proportion of falsely rejected hypotheses – the false discovery rate. This error rate is equivalent to the FWER when all hypotheses are true but is smaller otherwise. Therefore, in problems where the control of the false discovery rate rather than that of the FWER is desired, there is potential for a gain in power. A simple sequential Bonferroni-type procedure is proved to control the false discovery rate for independent test statistics, and a simulation study shows that the gain in power is substantial. The use of the new procedure and the appropriateness of the criterion are illustrated with examples.
The long-term efficacy of psychological interventions for bipolar disorders has not been tested.
This study assessed the efficacy of group psychoeducation to prevent recurrences and to reduce time spent ill for people with bipolar disorders.
A randomised controlled trial with masked outcome assessment comparing group psychoeducation and non-structured group intervention during 5-year follow-up. One hundred and twenty people with bipolar disorders were included in the study and 99 completed 5-year follow-up. Time to any recurrence, number of recurrences, total number of days spent ill, frequency and length of hospitalisations were the main outcome measures.
At the 5-year follow-up, time to any recurrence was longer for the psychoeducation group (log rank=9.953, P<0.002). The psychoeducation group had fewer recurrences (3.86 v. 8.37, F=23.6, P<0.0001) of any type and they spent less time acutely ill (154 v. 586 days, F=31.66, P=0.0001). The median number of days of hospitalisation per hospitalised participant was also lower for the psychoeducation group (45 v. 30, F=4.26, P=0.047).
Six-month group psychoeducation has long-lasting prophylactic effects in individuals with bipolar disorders. Group psychoeducation is the first psychological intervention showing such a long-term maintained efficacy in people with bipolar disorders.
Medication compliance is one of the foremost problems affecting neuroleptic efficacy in psychiatric patients. To date, compliancy has most commonly been assessed with the Drug Attitude Inventory (DAI) developed by Hogan et al. (Hogan, T.P., Awad, A.G., Eastwood, R., 1983. A self-report scale predictive of drug compliance in schizophrenics: reliability and discriminative validity. Psychol. Med. 13, 177-183). The present study identified several deficiencies in the DAI. Using the partial credit version of the Item Response Theory measurement model, the DAI was refined with the aim of greater validity and clinical utility. The new inventory was administered to 66 patients, the majority of whom were diagnosed with schizophrenia. When available, lithium levels and carer ratings of compliance were also recorded and used to verify compliancy. The new inventory appears to be a valid and reliable measure of compliancy for psychoactive medications.
Many behavioral and pharmacologic treatments for which there is strong empirical support are rarely used in clinical practice in the treatment of substance dependence. In an effort to facilitate greater emphasis on issues such as utility, practicality, and cost earlier in the evaluation of promising therapies, the authors propose a hybrid model to link efficacy and effectiveness research. A hybrid model may foster broader use of empirically validated treatments in substance abuse treatment programs and enhance the scientific yield of effectiveness research. The hybrid model retains essential features of efficacy research (randomization, use of control conditions, independent assessment of outcome, and monitoring of treatment delivery) while expanding the research questions to also address issues of importance in effectiveness studies. Such issues include diversity in settings, clinicians, and patients; cost-effectiveness of treatment; training issues; and patient and clinician satisfaction.
Recently the National Institutes of Health has been emphasizing research that takes findings generated by clinical research and translates them into treatments for patients who are seen in day-to-day nonresearch settings. This translational process requires a series of steps in which elements of both efficacy and effectiveness research are combined into successively more complex designs. However, there has been little discussion of exactly how to develop and operationalize these designs. This article describes an approach to the development of these hybrid designs. Their operationalization is illustrated by using the design of an ongoing effectiveness treatment study of panic disorder in primary care. Experts in both efficacy and effectiveness research collaborated to address the methodologic and data collection issues that need to be considered in designing a first-generation effectiveness study. Elements of the overall study design, setting or service delivery context, inclusion and exclusion criteria, recruitment and screening, assessment tools, and intervention modification are discussed to illustrate the thinking behind and rationale for decisions about these different design components. Although the series of decisions for this study were partly influenced by considerations specific to the diagnosis of panic disorder and the context of the primary care setting, the general stepwise approach to designing treatment interventions using an effectiveness model is relevant for the development of similar designs for other mental disorders and other settings.
To review the available literature on psychoeducation and cognitive-behavioral therapy (CBT) in bipolar disorder (BD) and to give an integral view of these therapies.
Studies were identified through Medline searches in English language publications between 1971 and 2003. This was supplemented by a hand search and the inclusion of selected descriptive articles on good clinical practice.
A number of studies demonstrate that psychoeducation enhances adherence to treatment, and one finds that it improves outcome in BD. Other studies find that CBT diminishes depressive symptoms and improves quality of life in BD. Occasionally some adverse effects may occur with psychotherapy and, although they are sporadic, should not be overlooked.
When combined with pharmacological treatment, psychoeducation helps to improve adherence. Training in the identification of early manic symptoms helps to improve outcomes and decreases the number of manic relapses in BD.
A relevant paradigm shift in the treatment of bipolar disorder started a few years ago; crucial findings on the usefulness of psychological interventions clearly support switching from an exclusively pharmacological therapeutic approach to a combined yet hierarchical model in which pharmacotherapy plays a central role, but psychological interventions may help cover the gap that exists between theoretical efficacy and "real world" effectiveness. Hereby we review the efficacy of several adjunctive psychotherapies in the maintenance treatment of bipolar patients.
A systematic review of the literature on the issue was performed, using MEDLINE and CURRENT CONTENTS databases. "Bipolar", "Psychotherapy", "Psychoeducation", "Cognitive-behavioral" and "Relapse prevention" were entered as keywords.
Psychological treatments specifically designed for relapse prevention in bipolar affective disorder are useful tools in conjunction with mood stabilizers. Most of the psychotherapy studies recently published report positive results on maintenance as an add-on treatment, and efficacy on the treatment of depressive episodes. Interestingly, several groups from all over the world reported similar positive results and reached very similar conclusions; almost every intervention tested contains important psychoeducative elements including both compliance enhancement and early identification of prodromal signs - stressing the importance of life-style regularity - and exploring patients' health beliefs and illness-awareness.
The usefulness of psychotherapy for improving treatment adherence and clinical outcome of bipolar patients is nowadays unquestionable, and future treatment guidelines should promote its regular use amongst clinicians. As clinicians, it is our major duty, to offer the best treatment available to our patients and this includes both evidence-based psychoeducation programs and newer pharmacological agents.
Mediating variables are prominent in psychological theory and research. A mediating variable transmits the effect of an independent variable on a dependent variable. Differences between mediating variables and confounders, moderators, and covariates are outlined. Statistical methods to assess mediation and modern comprehensive approaches are described. Future directions for mediation analysis are discussed.
Like recent medication studies, it appears that when cognitive-behavioural therapy is tested in pragmatic effectiveness trials involving routine clinical populations it does not fare as well as in efficacy trials. Given the multitude of factors that can ;muddy the waters' in clinical trials, how do we best make sense of the findings?
The common approach to the multiplicity problem calls for controlling the familywise error rate (FWER). This approach, though, has faults, and we point out a few. A different approach to problems of multiple significance testing is presented. It calls for controlling the expected proportion of falsely rejected hypotheses — the false discovery rate. This error rate is equivalent to the FWER when all hypotheses are true but is smaller otherwise. Therefore, in problems where the control of the false discovery rate rather than that of the FWER is desired, there is potential for a gain in power. A simple sequential Bonferronitype procedure is proved to control the false discovery rate for independent test statistics, and a simulation study shows that the gain in power is substantial. The use of the new procedure and the appropriateness of the criterion are illustrated with examples.
Despite evidence that psychotherapy has a positive impact on psychological disorders, 30% of patients fail to respond during clinical trials, and as many as 65% of patients in routine care leave treatment without a measured benefit. In addition, therapists appear to overestimate positive outcomes in their patients relative to measured outcomes and are particularly poor at identifying patients at risk for a negative outcome. These problems suggest the need for measuring and monitoring patient treatment response over the course of treatment while applying standardized methods of identifying at-risk cases. Computer-assisted methods for measuring, monitoring, identifying potential deteriorators, and providing feedback to clinicians are described along with a model that explains why feedback is likely to be beneficial to patients. The results of 12 clinical trials are summarized and suggest that deterioration rates can be substantially reduced in at-risk cases (from baseline rates of 21% down to 13%) and that recovery rates are substantially increased in this subgroup of cases (from a baseline of 20% up to 35%) when therapists are provided this information. When problem-solving methods are added to feedback, deterioration in at-risk cases is further reduced to 6% while recovery/improvement rates rise to about 50%. It is suggested that the feedback methods become a standard of practice. Such a change in patterns of care can be achieved through minimal modification to routine practice but may require discussions with patients about their clinical progress.
Background:
Bipolar disorder (BD) costs the English economy an estimated £5.2billion/year, largely through incomplete recovery. This analysis estimated the cost-effectiveness of group psychoeducation (PEd), versus group peer support (PS), for treating BD.
Methods:
A 96-week pragmatic randomised controlled trial (RCT), conducted in NHS primary care. The primary analysis compared PEd with PS, using multiple imputed datasets for missing values. An economic model was used to compare PEd with treatment as usual (TAU). The perspective was Health and Personal Social Services.
Results:
Participants receiving PEd (n=153) used more (costly) health-related resources than PS (n=151) (net cost per person £1098 (95% CI, £252-£1943)), with a quality-adjusted life year (QALY) gain of 0.023 (95% CI, 0.001-0.056). The cost per QALY gained was £47,739. PEd may be cost-effective (versus PS) if decision makers are willing to pay at least £37,500 per QALY gained. PEd costs £10,765 more than PS to avoid one relapse. The economic model indicates that PEd may be cost-effective versus TAU if it reduces the probability of relapse (by 15%) or reduces the probability of and increases time to relapse (by 10%).
Limitations:
Participants were generally inconsistent in attending treatment sessions and low numbers had complete cost/QALY data. Factors contributing to pervasive uncertainty of the results are discussed.
Conclusions:
This is the first economic evaluation of PEd versus PS in a pragmatic trial. PEd is associated with a modest improvement in health status and higher costs than PS. There is a high level of uncertainty in the data and results.
Objectives:
We investigated the feasibility and acceptability of an integrated group therapy (called HABIT) for comorbid bipolar disorder (BD) and alcohol and substance use disorders (ASUD) (BD-ASUD), a disabling clinical presentation for which no specific treatment has been validated. The 14-session HABIT programme employs psychoeducation-oriented cognitive-behaviour therapy (CBT) followed by mindfulness-based relapse prevention (MBRP) therapy.
Method:
Potential group participants were recruited from adult clients with a DSM-IV diagnosis of BD and an ASUD who were referred by their treating clinician. Observer-rated changes in mood symptoms and ASUD, attendance rates and subjective feedback are reported.
Results:
Eight of 12 clients referred to the programme initially agreed to join the group, six attended the first group session and five clients completed the programme. Group mean scores for mood symptoms improved over time, with slightly greater reductions in depression during the first module. About 50% of individuals showed clinically significant improvement (≥30% reduction) in alcohol and substance use. Attendance rates showed some variability between individuals and across sessions, but the average attendance rate of the group was marginally higher for the first module (86%) as compared with the second module (77%). Most clients reported high levels of general satisfaction with a group specifically targeted at individuals with BD-ASUD.
Conclusion:
This small pilot study suggests our intensive group therapy is acceptable and feasible. If findings are replicated, we may have identified a therapy that, for the first time, leads to improvement in both mood and substance use outcomes in clients with difficult-to-treat comorbid BD-ASUD. Copyright © 2016 John Wiley & Sons, Ltd. Key Practitioner Message Comorbidity between bipolar and alcohol and substance use disorders (BD-ASUD) is frequent and highly disabling; Therapeutic research on approaches that can simultaneously help BD and ASUD is lacking; Previous research highlights the need for integrated treatment of both conditions but showed improvements limited to either element of the comorbid disorder; This pilot study supports the feasibility and acceptability of an intensive, 14-session group therapy programme that integrates CBT and mindfulness approaches.
Background:
Group psychoeducation is a low-cost National Institute for Health and Care Excellence-recommended treatment for bipolar disorder. However, the clinical effectiveness and acceptability of this intervention are unclear compared with unstructured peer support matched for delivery and aim of treatment, and for previous bipolar history. We aimed to assess the clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder.
Methods:
We did this pragmatic, multicentre, parallel-group, observer-blind, randomised controlled superiority trial at eight community sites in two regions in England. Participants aged 18 years or older with bipolar disorder and no episode in the preceding 4 weeks were recruited via self-referral or secondary care referral. Participants were individually randomly assigned (1:1), via a computer-generated stochastic allocation sequence, to attend 21 2-h weekly sessions of either structured group psychoeducation or optimised unstructured peer support. Randomisation was minimised by number of previous episodes (one to seven, eight to 19, or ≥20) and stratified by clinical site. Outcome assessors were masked to group allocation. The primary outcome was time from randomisation to next bipolar episode, with planned moderator analysis of number of previous bipolar episodes and qualitative interview of participant experience. We did analysis by intention to treat. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN62761948.
Findings:
Between Sept 28, 2009, and Jan 9, 2012, we randomly assigned 304 participants to receive psychoeducation (n=153) or peer support (n=151); all (100%) participants had complete primary outcome data. Attendance at psychoeducation groups was higher than at peer-support groups (median 14 sessions [IQR three to 18] vs nine sessions [two to 17]; p=0·026). At 96 weeks, 89 (58%) participants in the psychoeducation group had experienced a next bipolar episode compared with 98 (65%) participants in the peer-support group; time to next bipolar episode did not differ between groups (hazard ratio [HR] 0·83, 95% CI 0·62-1·11; p=0·217). Planned moderator analysis showed that psychoeducation was most beneficial in participants with few (one to seven) previous bipolar episodes (χ2; HR 0·28, 95% CI 0·12-0·68; p=0·034). Four (1%) participants (one in the psychoeducation group and three in the peer-support group) died during follow-up; these deaths were deemed unrelated to the study interventions or procedures.
Interpretation:
Structured group psychoeducation was no more clinically effective than similarly intensive unstructured peer support, but was more acceptable and improved outcome in participants with fewer previous bipolar episodes. Optimum provision of structured psychological interventions, such as group psychoeducation, early in the course of bipolar disorder might have important benefits on the course of illness, and merits further research.
Funding:
National Institute for Health Research.
Background:
In this effectiveness trial we compared the long-term effects on hospitalizations of group psychoeducation (GP) versus individual psychoeducation (IP) for a heterogeneous sample of patients with BD recruited from general clinical settings.
Methods:
Eighty-five patients with BD were randomized to receive 10 weekly sessions of GP followed by 8 booster-sessions over the next two years, or three sessions of IP. Time to first admission over the course of GP was the primary outcome measure, with additional outcomes examining the use of psychiatric services over about 8 years.
Results:
Patients allocated to GP had longer survival time compared to IP over 27 months (p<0.05). There were also group differences in survival time over 8 years, but treatment allocation alone was no longer a significant predictor of survival time (p=0.07). There was an interaction between group (GP/IP) and harmful substance use (HSU), such that GP cases with comorbid HSU had the shortest survival time, whilst GP cases without HSU survived the longest (p=0.02). Also, GP cases had a small but significant reduction in hospital use compared with IP (p=0.04).
Limitations:
We did not have a 'pure' treatment as usual group. Wide confidence intervals for some of the odds ratios suggest that the findings need to be treated with some caution. Insufficient sample size for more detailed subgroup analyses.
Conclusions:
GP is superior to IP in delaying hospitalizations in a clinically representative population. However, GP did not prevent or delay admissions in BD patients with HSU.
Although the mainstay of bipolar therapy is drug treatment, psychoeducation is a technique that has proven to be very effective as an add-on to medication, helping to reduce the number of all types of bipolar recurrences and hospitalisation. The object is to improve patients’ understanding of the disorder and therefore their adherence to pharmacotherapy. Based on the highly successful, evidence-based Barcelona program, this book is a pragmatic, therapists’ guide for how to implement psychoeducation for bipolar patients. It gives practical guidance for how to conduct a psychoeducation group, using sessions and cases drawn from the Barcelona Psychoeducation Program. Moreover, it provides the reader with a great amount of practical tips and tricks and specific techniques to maximize the benefits of bipolar psychoeducation. The authors formed the first group to show the efficacy of psychoeducation as a maintenance treatment and have a long history of performing bipolar psychoeducation. © Cambridge University Press 2006 and Cambridge University Press, 2009.
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.
© 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Randomized trials of adjunctive psychotherapy for bipolar disorder are reviewed, in tandem with discussion of cost-effectiveness, mediating mechanisms, and moderators of effects.
Systematic searches of the MEDLINE and PSYCHLIT databases yielded 19 randomized controlled trials of individual family and group therapies. Outcome variables included time to recovery, relapse or recurrence, symptom severity, medication adherence, and psychosocial functioning.
Meta-analyses consistently show that disorder-specific psychotherapies [cognitive-behavioral therapy (CBT), interpersonal, family, and group] augment mood stabilizers in reducing rates of relapse (OR = 0.57; 95% CI: 0.39-0.82) over 1-2 years. Specific mediating mechanisms include, but are not limited to, increasing medication adherence, teaching self-monitoring and early intervention with emergent episodes, and enhancing interpersonal functioning and family communication. All therapies have strengths and weaknesses. One group psychoeducation trial, demonstrated effect sizes for recurrence that are at least equivalent to individual therapies, but findings await replication. Family interventions have been successfully administered in both single and multi-family formats, but no studies report the comparative cost-effectiveness of these formats. The best-studied psychotherapy modality, CBT, can have beneficial effects on depression, but findings are inconsistent across studies and vary with sample characteristics and comparison treatments.
Adjunctive psychotherapies can be cost-effective when weighed against observed reductions in recurrence, hospitalization and functional impairments. Future trials need to (i) clarify which populations are most likely to benefit from which strategies; (ii) identify putative mechanisms of action; (iii) systematically evaluate costs, benefits, and generalizability; and (iv) record adverse effects. The application of psychosocial interventions to young-onset populations deserves further study.
The burden that disease places on societies around the world is complex and changing as communicable diseases are replaced by noncommunicable diseases. This article summarizes these changes and the current burden. It is difficult to deliver effective and high-quality care to patients without knowing their diagnoses; likewise, for health systems to be effective, it is necessary to understand the key challenges in efforts to improve population health and how these challenges are changing. Before the early 1990s, there was no comprehensive and internally consistent source of information on the global burden of diseases, injuries, and risk factors. To close this gap, the World Bank and the World Health Organization launched the Global Burden of Disease (GBD) Study in 1991.(1) Although assessments of selected diseases, injuries, and risk factors in selected populations ...
Recent reviews of evidence-based guidelines for the clinical management of Bipolar Disorders (BD) have recommended that "all patients with BD be offered group or individual psychoeducation" to prevent relapse, improve treatment adherence, quality of life, and functioning. The present study evaluated the effectiveness of psychoeducation in routine mental health services in reducing number of hospitalisations and number of days spent in hospital, at a 1-year follow-up.
A total of 102 outpatients were recruited from two Italian Departments of Mental Health. Inclusion criteria were a lifetime BD type I or II diagnosis, assessed with SCID, and ≥3 months of euthymia. Exclusion criteria were DSM-IV Axis I comorbidity, mental retardation (IQ<70), organic brain damage, or deafness. All participants received standard psychiatric care, including standard pharmacological treatment; the experimental group also received 21 group psychoeducation sessions, weekly held and conducted according to Colom and Vieta's model.
The number of patients hospitalised during the 1-year follow-up, the mean number of hospitalisations per patient, and the mean number of hospitalisation days were significantly lower for psychoeducated patients.
Our findings support the view that group psychoeducation is an effective way to prevent hospitalisation and decrease hospital days in pharmacologically treated patients with bipolar disorder also in routine clinical settings. The results confirm that psychoeducation promotes improvement in illness course by preventing acute phases and enhancing mood stability, and consequently, improvement in the quality of life for people with BD.
BACKGROUND: Psychiatric stigma is pervasive injustice that complicates the course of illness and reduces quality of life for people with mental illnesses. This article reviews the research examining stigma towards bipolar disorder (BD) with a view to guiding the development of stigma reduction initiatives and ongoing research. METHODS: PsychInfo, Medline, and Embase databases were searched for peer-reviewed studies addressing stigma in BD. RESULTS: Stigma is a serious concern for individuals with BD and their families. Stigma occurs within affected individuals, families, social environments, work and school environments, and the healthcare industry. With stigma often come a loss of social support and occupational success, reduced functioning, higher symptom levels and lower quality of life. BD stigma is comparable to that of other severe mental illnesses, such as schizophrenia. Few interventions are available to specifically target stigma against BD. LIMITATIONS: Most studies have used explicit, attitude-based measures of stigma without controlling for social desirability, which may not translate into real-world stigmatizing behaviors. Furthermore, many studies have not clearly delineated results in a manner consistent with the conceptual framework of stigmatization. CONCLUSIONS: Stigma toward BD is ubiquitous and has insidious consequences for affected individuals and their families. Stigma reduction initiatives should target individuals living with BD, their families, workplaces, and the healthcare industry, taking into account the experiences and impacts of BD stigma to improve social support, course of illness, and quality of life.
Research on the generalizability of clinical trial results for bipolar disorder is limited. The present post hoc study sought to quantify the generalizability of clinical trial results in individuals with DSM-IV bipolar disorder to a large representative community sample.
Data were derived from the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large, nationally representative sample of 43,093 adults from the United States population. We applied a standard set of eligibility criteria representative of clinical trials to all adults with DSM-IV bipolar depression (n = 785) or mania (n = 724) in the past 12 months and then to a subsample of participants seeking treatment for bipolar depression (n = 276). Our aim was to determine the proportion of participants with bipolar depression or acute mania who would have been excluded from a clinical trial by typical eligibility criteria.
We found that more than 5 of 10 participants with bipolar depression (58.17%) or mania (55.75%) would have been excluded by at least 1 eligibility criterion. In the subgroup of participants with bipolar depression who sought treatment, the exclusion rate by at least 1 criterion was higher (63.87%). Having a significant risk of suicide was the criterion excluding the highest percentage of participants in the bipolar depression samples, while having a current DSM-IV diagnosis of alcohol abuse or dependence was the one leading to the greatest exclusion rate in clinical trials for participants with acute mania. Exclusion rates were higher for participants with bipolar I depression compared with those with bipolar II depression.
Traditional clinical trials tend to exclude a majority of individuals with bipolar disorder. Clinical trials should carefully consider the impact of eligibility criteria on the generalizability of their results and explain the rationale for their use. Future trials should weigh the trade-offs between internal validity and the representativeness of the study.
Yatham LN, Kennedy SH, Parikh SV, Schaffer A, Beaulieu S, Alda M, O’Donovan C, MacQueen G, McIntyre RS, Sharma V, Ravindran A, Young LT, Milev R, Bond DJ, Frey BN, Goldstein BI, Lafer B, Birmaher B, Ha K, Nolen WA, Berk M.
Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013.
Bipolar Disord 2012: 00: 000–000. © 2012 John Wiley & Sons A/S.Published by Blackwell Publishing Ltd.
The Canadian Network for Mood and Anxiety Treatments published guidelines for the management of bipolar disorder in 2005, with updates in 2007 and 2009. This third update, in conjunction with the International Society for Bipolar Disorders, reviews new evidence and is designed to be used in conjunction with the previous publications.The recommendations for the management of acute mania remain largely unchanged. Lithium, valproate, and several atypical antipsychotic agents continue to be first‐line treatments for acute mania. Monotherapy with asenapine, paliperidone extended release (ER), and divalproex ER, as well as adjunctive asenapine, have been added as first‐line options.For the management of bipolar depression, lithium, lamotrigine, and quetiapine monotherapy, as well as olanzapine plus selective serotonin reuptake inhibitor (SSRI), and lithium or divalproex plus SSRI/bupropion remain first‐line options. Lurasidone monotherapy and the combination of lurasidone or lamotrigine plus lithium or divalproex have been added as a second‐line options. Ziprasidone alone or as adjunctive therapy, and adjunctive levetiracetam have been added as not‐recommended options for the treatment of bipolar depression. Lithium, lamotrigine, valproate, olanzapine, quetiapine, aripiprazole, risperidone long‐acting injection, and adjunctive ziprasidone continue to be first‐line options for maintenance treatment of bipolar disorder. Asenapine alone or as adjunctive therapy have been added as third‐line options.
Objective:
The purpose of this project was to engage a diverse group of stakeholders (N=38) to help establish priorities to guide patient-centered outcomes research (PCOR) in serious mental illness.
Methods:
Three meetings, two Web-based and one on site, were held to generate and prioritize an initial list of topics. Topics were then sorted and organized into common themes.
Results:
About 140 topics were identified and sorted into 21 main themes, ranked by priority. Three of the top four themes focused on how research was conducted, particularly the need to develop consensus measurement and outcomes definitions; improving infrastructure for research, longitudinal studies, and new data sets and investigators; and developing PCOR methodology. Stakeholders also identified a need to focus on service delivery, treatment settings, and structure of the delivery of care.
Conclusions:
Engagement by a broad group of stakeholders in a transparent process resulted in the identification of priority areas for PCOR. Stakeholders clearly indicated a need to fundamentally change how research on serious mental illness is conducted and a critical need for the development of methodology and infrastructure. Most current PCOR has been focused on relatively short-term outcomes, but real world, long-term studies providing guidance for treatment over the lifetime of a serious mental illness are needed.
BACKGROUND: In schizophrenia, high levels of critical comments by significant others are associated with early relapse, especially if medication adherence is sub-optimal. Levels of criticism may be influenced by family knowledge about both the disorder and its treatment. No study has explored whether this combination factors influence outcome in adults with bipolar disorders. METHODS: Medication adherence was assessed in 81 individuals with bipolar disorder of whom 75 rated perceived criticism by an identified 'significant other' as well as their own perceived sensitivity. 33 (of the 75) had a close family member who agreed to completed an assessment of their knowledge and understanding of bipolar disorders. Psychiatric admissions were then recorded prospectively over 12 months. RESULTS: Perceived criticism and medication adherence were significant predictors of admission. In the patient-family member dyads (n=33), the odds ratio (OR) for admission was 3.3 (95% confidence intervals 1.3-8.6) in individuals with low levels of medication adherence, high perceived criticism, and a family member with poor knowledge and understanding. LIMITATIONS: The small sub-sample of patient-family member dyads means those findings require replication. Sensitivity to criticism by professional caregivers may not equate to that by relatives. CONCLUSIONS: Perceived criticism may be a simple but robust clinical predictor of relapse in mood disorders. High levels of perceived criticism, poor understanding of bipolar disorder by a significant other, and sub-optimal treatment adherence are risk factors for hospitalization in adults with bipolar disorders that are potentially modifiable through the use of strategic psychosocial interventions.
Bipolar disorder is insufficiently controlled by medication, so several adjunctive psychosocial interventions have been tested. Few studies have compared these psychosocial treatments, all of which are lengthy, expensive, and difficult to disseminate. We compared the relative effectiveness of a brief psychoeducation group intervention to a more comprehensive and longer individual cognitive-behavioral therapy intervention, measuring longitudinal outcome in mood burden in bipolar disorder.
This single-blind randomized controlled trial was conducted between June 2002 and September 2006. A total of 204 participants (ages 18-64 years) with DSM-IV bipolar disorder type I or II participated from 4 Canadian academic centers. Subjects were recruited via advertisements or physician referral when well or minimally symptomatic, with few exclusionary criteria to enhance generalizability. Participants were assigned to receive either 20 individual sessions of cognitive-behavioral therapy or 6 sessions of group psychoeducation. The primary outcome of symptom course and morbidity was assessed prospectively over 72 weeks using the Longitudinal Interval Follow-up Evaluation, which yields depression and mania symptom burden scores for each week.
Both treatments had similar outcomes with respect to reduction of symptom burden and the likelihood of relapse. Eight percent of subjects dropped out prior to receiving psychoeducation, while 64% were treatment completers; rates were similar for cognitive-behavioral therapy (6% and 66%, respectively). Psychoeducation cost 1,200 per subject.
Despite longer treatment duration and individualized treatment, cognitive-behavioral therapy did not show a significantly greater clinical benefit compared to group psychoeducation. Psychoeducation is less expensive to provide and requires less clinician training to deliver, suggesting its comparative attractiveness.
ClinicalTrials.gov identifier: NCT00188838.
Comparative effectiveness research (CER) seeks to inform clinical decisions between alternate treatment strategies using data that reflects real patient populations and real-world clinical scenarios for the purpose of improving patient outcomes. There are multiple clinical situations where the unique characteristics of observational investigations can inform medical decision-making within the CER paradigm. Accordingly, it is critical for clinicians to appreciate the strengths and limitations of observational research, particularly as they apply to CER.
This review focuses on the role of observational research in CER. We discuss the concept of evidence hierarchies as they relate to observational research and CER, review the scope and nature of observational research, present the rationale for its inclusion in CER investigations, discuss potential sources of bias in observational investigations as well as strategies used to compensate for these biases, and discuss a framework to implement observational research in CER.
The CER paradigm recognizes the limitations of hierarchical models of evidence and favors application of a strength-of-evidence model. In this model, observational research fills gaps in randomized clinical trial data and is particularly valuable to investigate effectiveness, harms, prognosis, and infrequent outcomes as well as in circumstances where randomization is not possible and in studies of many surgical populations. Observational investigations must be designed with careful consideration of potential sources of bias and must incorporate strategies to control such bias prospectively, and their results must be reported in a uniform and transparent fashion. When these conditions can be achieved, observational research represents a valuable and critical component of modern CER.
Health insurers, physicians, and patients worldwide need information on the comparative effectiveness and safety of prescription drugs in routine care. Nonrandomized studies of treatment effects using secondary databases may supplement the evidence based from randomized clinical trials and prospective observational studies. Recognizing the challenges to conducting valid retrospective epidemiologic and health services research studies, a Task Force was formed to develop a guidance document on state of the art approaches to frame research questions and report findings for these studies.
The Task Force was commissioned and a Chair was selected by the International Society for Pharmacoeconomics and Outcomes Research Board of Directors in October 2007. This Report, the first of three reported in this issue of the journal, addressed issues of framing the research question and reporting and interpreting findings.
The Task Force Report proposes four primary characteristics-relevance, specificity, novelty, and feasibility while defining the research question. Recommendations included: the practice of a priori specification of the research question; transparency of prespecified analytical plans, provision of justifications for any subsequent changes in analytical plan, and reporting the results of prespecified plans as well as results from significant modifications, structured abstracts to report findings with scientific neutrality; and reasoned interpretations of findings to help inform policy decisions.
Comparative effectiveness research in the form of nonrandomized studies using secondary databases can be designed with rigorous elements and conducted with sophisticated statistical methods to improve causal inference of treatment effects. Standardized reporting and careful interpretation of results can aid policy and decision-making.
To explore the short- and long-term mental health resource utilization and cost of care in a sample of 120 individuals with bipolar disorders who participated in a randomized controlled efficacy trial of group psychoeducation versus unstructured group support.
Prospective, independent monitoring of DSM-IV bipolar disorder type I or II patients aged 18 to 65 years was conducted during the intervention phase (6 months) and follow-up phase (5-year postintervention) of a randomized controlled trial reporting clinical outcomes and inpatient and outpatient mental health service utilization, with estimation of cost of treatment per patient. The study was conducted from October 1997 through October 2006.
Compared with individuals with bipolar disorder receiving the control intervention, psychoeducated patients had twice as many planned outpatient appointments, but the estimated mean cost of emergency consultation utilization was significantly less. There were trends for psychoeducated patients to opt for self-funded psychotherapy after completing group psychoeducation and to utilize more medications. However, inpatient care accounted for 40% estimated total cost in the control group but only about 15% in the psychoeducation group.
This study demonstrates the importance of taking a long-term overview of the cost versus benefits of adjunctive psychological therapy in bipolar disorders. If viewed only in the short-term, the psychoeducation group used more mental health care resources without clear additional health gain. However, extended follow-up demonstrated a long-term advantage for psychoeducated individuals, such that, compared to an unstructured support group intervention, group psychoeducation is less costly and more effective.
An eleven item clinician-administered Mania Rating Scale (MRS) is introduced, and its reliability, validity and sensitivity are examined. There was a high correlation between the scores of two independent clinicians on both the total score (0.93) and the individual item scores (0.66 to 0.92). The MRS score correlated highly with an independent global rating, and with scores of two other mania rating scales administered concurrently. The score also correlated with the number of days of subsequent stay in hospital. It was able to differentiate statistically patients before and after two weeks of treatment and to distinguish levels of severity based on the global rating.
This study explored the utility of Health Belief Models (HBM) in explaining medication adherence in subjects with severe affective disorders.
Well-established measuring instruments, with confirmed reliability and validity, were used to assess each component of two HBMs and adherence to mood-stabilising medication in 98 subjects with either bipolar (805 subjects) or unipolar disorders.
About 30% of subjects met criteria for partial adherence to medication. Demographic and diagnostic variables did not predict adherence status. Subjects' beliefs about themselves and their control over the disorder were more important than side-effects in predicting medication adherence. Self-reported assessments were predictive of admission to hospital in the year after the interview.
Although the study has a number of methodological limitations, the results suggest that clinical assessment of components of HBMs may improve the detection of patients at risk of non-adherence to mood-stabilising medication.
Studies on individual psychotherapy indicate that some interventions may reduce the number of recurrences in bipolar patients. However, there has been a lack of structured, well-designed, blinded, controlled studies demonstrating the efficacy of group psychoeducation to prevent recurrences in patients with bipolar I and II disorder.
One hundred twenty bipolar I and II outpatients in remission (Young Mania Rating Scale score <6, Hamilton Depression Rating Scale-17 score <8) for at least 6 months prior to inclusion in the study, who were receiving standard pharmacologic treatment, were included in a controlled trial. Subjects were matched for age and sex and randomized to receive, in addition to standard psychiatric care, 21 sessions of group psychoeducation or 21 sessions of nonstructured group meetings. Subjects were assessed monthly during the 21-week treatment period and throughout the 2-year follow-up.
Group psychoeducation significantly reduced the number of relapsed patients and the number of recurrences per patient, and increased the time to depressive, manic, hypomanic, and mixed recurrences. The number and length of hospitalizations per patient were also lower in patients who received psychoeducation.
Group psychoeducation is an efficacious intervention to prevent recurrence in pharmacologically treated patients with bipolar I and II disorder.
Several previous studies have established that low treatment adherence is common among bipolar patients and may explain high rates of recurrence. On the other hand, some patients keep relapsing even when they strictly follow their prescribed somatic treatments. Psychological interventions such as psychoeducation may foster early recognition of prodromal symptoms and minimize the risk of relapse. To date, studies assessing the usefulness of psychoeducation in fully compliant patients are lacking.
This was a single-blind, randomized, prospective clinical trial on the efficacy of group psychoeducation in remitted fully compliant DSM-IV bipolar I patients (N = 25) who were compared with a group with similar characteristics (N = 25) who did not receive psychoeducation. All patients received naturalistic pharmacologic treatment. Recruitment began in 1997 and follow-up was completed in January 2002. The follow-up phase comprised 2 years during which all patients continued receiving naturalistic treatment without psychological intervention and were assessed monthly on several outcome measures.
At the end of the 2-year follow-up, 23 subjects (92%) in the control group fulfilled criteria for recurrence versus 15 patients (60%) in the psychoeducation group (p < .01). The number of total recurrences and the number of depressive episodes were significantly lower in psychoeducated patients.
Although the present study has the limitation of small sample size, psychoeducation showed its efficacy in preventing relapses in bipolar I patients who were adherent to drug treatment. The action of psychoeducation seems to go beyond compliance enhancement and may support a tripod model composed by lifestyle regularity and healthy habits, early detection of prodromal signs followed by prompt drug intervention, and finally treatment compliance.
The chronicity and cyclical nature of bipolar disorder combined with the irrationality typical during bipolar mood episodes often encourage pharmacologic treatment nonadherence, which heightens the severity of the illness. Although clinicians acknowledge treatment nonadherence to be a major issue among bipolar patients, assessing nonadherence is difficult, and improving treatment adherence is a complicated and delicate matter. Treatment adherence can be improved among patients with bipolar disorder through psychoeducation about the nature of their disorder and the vital importance of treatment adherence. Founded on a biopsychosocial, medical model of mental disorders, psychoeducation empowers the patient by providing a practical and theoretical approach to understanding and dealing with the symptoms and consequences of bipolar disorder. Psychoeducation identifies bipolar disorder as a biological abnormality that requires regular pharmacologic treatment and teaches patients to cope with symptoms and maintain regularity in daily social and occupational functioning. Psychoeducated patients show improvements in treatment adherence and in other clinical outcomes, including reduced number of mood episodes and hospitalizations and increased time between episodes. As an adjunct to pharmacotherapy of bipolar disorder, psychoeducation is a promising management component that increases treatment adherence and quality of life for patients.
Although everyone working in routine mental health services recognizes the scientific and ethical importance to ensure that treatments being provided are of highest quality, there is a clear lack of consensus regarding what outcome domains to include, what measure of assessment to use and, moreover, who to question when assessing.
Since the fifties, social functioning is considered as an important dimension to take into account for treatment planning and outcome measuring. But for many years, symptoms scales have been considered as sufficient outcome measures and social functioning improvement expected on the basis of symptoms alleviation. As symptoms and social adjustment sometimes appear relatively independent, no accurate conclusion concerning the patient's social functioning can so be driven on the basis of his clinical symptoms. More attention has then been directed toward the development of instruments specifically intended to measure the extent and nature of social functioning impairments observed in most psychiatric syndromes. Many of these instruments are designed to be completed by caregivers or remain time consuming and difficult to use routinely. Presently, in clinical practice, there is a need to rely on simple and brief instruments considering patients'perspective about their social adjustment as a function of time.
The aim of this study is to present a new instrument, the QFS, initially developed in order to assess social functioning in patients involved in group psychotherapy programs conducted in a specialist mental health setting, as well as its psychometric characteristics.
It was designed to be completed in less than 10 minutes and the questions are phrased in a simple and redundant way, in order to limit problems inherent to illiteracy or language comprehension. The QFS is a 16 items self-report instrument that assesses both the frequency of (8 items) and the satisfaction with (8 items) various social behaviours adopted during the 2 weeks period preceding the assessment. It yields three separate indexes of social functioning, defined a priori and labelled "frequency", "satisfaction" and "global". The higher the scores, the better the social functioning. The QFS was administered to 457 subjects, aged between 18 and 65, including 176 outpatients (99 with anxious or depressive disorders, 25 with personality disorders and 52 with psychotic disorders) and 281 healthy control subjects.
No significant difference was found between patients and controls according to age or gender distribution. Acceptance rate was high (>95%). Moreover, the QFS was generally acceptable to the clinicians who used it. Internal consistency calculated for each index ranged from 0.65 to 0.83 (Cronbach alpha). Test-retest reliability, calculated within a 15 days time interval on a sample of 49 healthy controls, ranged from 0.69 to 0.71 (intraclass correlation coefficient). Discriminant validity was calculated on healthy controls and patients divided into sub-groups according to their diagnosis. It showed to be excellent, with significantly higher scores in control subjects than in psychiatric patients and significant differences across diagnostic categories (Kruskal-Wallis ANOVA with post-hoc tests, all p<0.05). The convergent validity of the QFS with other measures of social functioning was calculated, using the Social Adaptation Self-Evaluation Scale (SASS) and the Social Adjustment Scale Self-Report (SAS-SR). With the SASS, the convergent validity was higher among patients (Spearman rS 0.71 to 0.92, p<0.01) than controls (rS from 0.49 to 0.66, p<0.001). In healthy controls, correlation with the SAS-SR was moderate but statistically significant (rS from - 0.21 to - 0.44, p<0.05). When comparing QFS scores with self-rated symptoms severity, lower levels of social functioning were significantly associated with more severe symptoms according to the Brief Symptom Inventory (BSI: rS from - 0.38 to - 0.65, p<0.001). The QFS indexes demonstrated sensitivity to change (Wilcoxon: all p<0.05) on a sample of 27 out-patients suffering from anxious-depressive disorders questioned before and after 4 months of cognitive behavioural group therapy running on a weekly basis during 16 sessions of 2 hours each.The factorial validity of the QFS was measured through 3 separate factor analysis conducted using the data of 457 subjects. The first analysis considered only Frequency items; 7 out of 8 items had loadings above 0.5 on Factor 1 accounting for 30.7% (unrotaded) of the variance. The second analysis considered only Satisfaction items; all items had loadings above 0.6 on Factor 1 explaining 43.4% (unrotaded) of the variance. And finally, in the third factor analysis, all QFS items were included; 15 out of 16 items had loadings above 0.4 on Factor 1 accounting for 30% (unrotated) of the variance. Concerning the factorial validity of the instrument, these results suggest that all QFS items belong to the same underlying dimension.
Finally, provisional norms for the QFS are provided for healthy controls, in order to characterise individual patients or patient subgroups. In conclusion, the need for assessment in clinical routine, in order to estimate different aspects of patients conditions as well as the quality of the treatment provided, has contributed to the development of a large variety of instruments measuring several domains. Concerning the level of social functioning, many instruments fail to meet chief criterion of feasibility, remaining often too complex or time onsuming. Moreover, only few of them are available in French.
The QFS presented here is a brief, simple and easy to administer self-rating scale that displays satisfactory psychometric properties. It seems to be a valuable instrument for the monitoring of social functioning in psychiatric patients which, from a therapeutic point of view, may have a clear impact as it sets up expectation of change and allows both to reality test patients and therapists beliefs about the presence of progress or not and to identify if therapy is working on this specific outcome domain. Though, to date, the administration of the QFS to other populations and treatment modalities requires further investigation.
This study evaluates the Brief Illness Perception Questionnaire (Brief IPQ), a nine-item scale designed to rapidly assess the cognitive and emotional representations of illness.
We assessed the test-retest reliability of the scale in 132 renal outpatients. We assessed concurrent validity by comparing the Brief IPQ with the Illness Perception Questionnaire-Revised (IPQ-R) and other relevant measures in 309 asthma, 132 renal, and 119 diabetes outpatients. Predictive validity was established by examining the relationship of Brief IPQ scores to outcomes in a sample of 103 myocardial infarction (MI) patients. Discriminant validity was examined by comparing scores on the Brief IPQ between five different illness groups.
The Brief IPQ showed good test-retest reliability and concurrent validity with relevant measures. The scale also demonstrated good predictive validity in patients recovering from MI with individual items being related to mental and physical functioning at 3 months' follow-up, cardiac rehabilitation class attendance, and speed of return to work. The discriminant validity of the Brief IPQ was supported by its ability to distinguish between different illnesses.
The Brief IPQ provides a rapid assessment of illness perceptions, which could be particularly helpful in ill populations, large-scale studies, and in repeated measures research designs.