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Designed to help readers manage recurring depression, hypomania, and anxiety associated with bipolar II disorder, drawing on evidence-based cognitive behavioral therapy (CBT), dialectical behavioral therapy (DBT), and other mindfulness-based approaches.

This review article emphasizes the challenges pediatric patients face during obesity treatment. Prior research has been compartmentalized, acknowledging that stigma, the ability to implement lifestyle changes, social health determinants, and healthcare accessibility are considerable impediments for obese children. These issues emerge at various levels, including the individual or family, the community and school, and even national policy. This suggests the need for a more comprehensive, team-based approach to tackle pediatric obesity. Understanding these barriers is the first step toward creating effective strategies and solutions to overcome these challenges.

The impact of anxiety disorders has not been well delineated in prospective studies of bipolar disorder. To examine the association between anxiety and course of bipolar disorder, as defined by mood episodes, quality of life and role functioning. A thousand thousand out-patients with bipolar disorder were followed prospectively for 1 year. A current comorbid anxiety disorder (present in 31.9% of participants) was associated with fewer days well, a lower likelihood of timely recovery from depression, risk of earlier relapse, lower quality of life and diminished role function over I year of prospective study. The negative impact was greater with multiple anxiety disorders. Anxiety disorders, including those present during relative euthymia, predicted a poorer bipolar course. The detrimental effects of anxiety were not simply a feature of mood state. Treatment studies targeting anxiety disorders will help to clarify the nature of the impact of anxiety on bipolar course.

The Bipolar II Disorder Workbook is designed to help readers manage recurring depression, hypomania, and anxiety associated with bipolar II disorder. This user-friendly self-help workbook draws on evidence-based cognitive behavioral therapy (CBT), dialectical behavioral therapy (DBT), and other mindfulness-based approaches to help those suffering from bipolar II disorder live more normal lives.

Background Classic and second-generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the ‘real-world’ advantages and disadvantages of these medications. Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This article outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments (APTs). The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score, and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT). Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus APT, across 10 sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. In all, 482 participants were randomized to the study, and 364 completed the study. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications. Conclusion We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second-generation antipsychotic with broad-spectrum activity in bipolar disorder, and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial.

Whereas an abundance of studies have been devoted to the study of cognitive vulnerability in unipolar depression, comparatively less is known regarding the cognitive styles of patients with bipolar disorder. This study examined the cognitive styles of 395 of the first 500 bipolar patients enrolled in the NIMH Systematic Treatment Enhancement Program for Bipolar Disorder as a function of mood state at study entry. Patients completed diagnostic and mood assessments and two measures of cognitive style: The Dysfunctional Attitudes Scale (DAS) and the Attributional Style Questionnaire (ASQ). Patients in mixed episodes exhibited significantly more negative dysfunctional attitudes and negative attributional styles than euthymic patients and significantly more dysfunctional attitudes than manic/hypomanic patients. The implications of these findings are discussed in relation to episode vulnerability, mood-state dependency of cognitive style, and cognitive-behavioral treatment.

Background Recent data indicate that lithium use for bipolar disorder has declined over the last decade and that lithium largely has been replaced with alternate, commercially promoted medications that may or may not result in better outcomes. Purpose This article describes the rationale and study design of LiTMUS, a multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. LiTMUS seeks to address whether initiating therapy at lower doses of lithium as part of optimized treatment (OPT, guideline-informed, evidence-based, and personalized pharmacotherapy) improves outcomes and decreases the need for other medication changes across 6 months of therapy. Methods LiTMUS will randomize 284 adults with bipolar disorder (Type I or II) across 6 study sites. The co-primary outcomes are overall illness severity on clinical global improvement scale for bipolar disorder and a novel measure, necessary clinical adjustments. This metric provides a composite that reflects both clinical response and tolerability. Other relevant outcomes include full symptomatic recovery, quality of life, suicidal behaviors, and moderators of suicidality. Results As of August 28th, 2009, we have consented 338 patients and randomized 281 for this study. Limitations The potential limitations of the study include an arbitrary definition of ‘low, but effective’ doses of lithium, lack of a placebo-controlled group, open treatment, and use of a new outcome measure (i.e., necessary clinical adjustments). Conclusion We expect that this study will inform our understanding of the effectiveness of low to moderate doses of lithium therapy for individuals with bipolar disorder. Clinical Trials 2009; 6: 637—648. http://ctj.sagepub.com

This study examined the effectiveness of a new type of purely Beckian cognitive treatment for Obsessive-Compulsive Disorder (OCD). The manualized treatment used a flexible format permitting therapists to choose among several modules developed to address specific OCD belief domains identified by the Obsessive-Compulsive Cognition Working Group (1997). Fifteen participants diagnosed with OCD were treated individually for 14 weekly sessions. Ten participants had never received behavior therapy, and 5 participants had failed to benefit from exposure and response prevention (ERP) in the past. Participants improved with respect to their depressive and obsessive-compulsive symptoms over the course of the treatment. However, those who had never received ERP improved more than those who had failed to benefit from prior ERP. Implications of the study are discussed.

Background High attrition rates, which occur frequently in longitudinal clinical trials of interventions for bipolar disorder, limit the interpretation of results. Purpose The aim of this article is to present design approaches that limited attrition in the Lithium Treatment – Moderate dose Use Study (LiTMUS) for bipolar disorder. Methods LiTMUS was a 6-month randomized, longitudinal multisite comparative effectiveness trial that enrolled bipolar participants who were at least mildly ill. Participants were randomized to either low to moderate doses of lithium or no lithium; other treatments needed for mood stabilization were administered in a guideline-informed, empirically supported, and personalized fashion to participants in both treatment arms. Results Components of the study design that may have contributed to low attrition (16%) among 283 participants randomized included the use of (1) an intent-to-treat design, (2) a randomized adjunctive single-blind design, (3) participant reimbursement, (4) assessment of intent to attend the next study visit (included a discussion of attendance obstacles when intention was low), (5) quality care with limited participant burden, and (6) target windows for study visits. Limitations The relationships between attrition and effectiveness and tolerability of treatment have not been analyzed yet. Conclusions These components of the LiTMUS design may have limited attrition and may inform the design of future randomized comparative effectiveness trials among similar patients and those from other difficult-to-follow populations.