Bipolar Disorder: Bauer MS

Bauer MS, Callahan AM, Jampala C, Petty F, Sajatovic M, Schaefer V, Wittlin B, Powell BJ. · Department of Veterans Affairs, Medical Center, Providence, RI 02908-4799, USA. · J Clin Psychiatry. · Pubmed #10074872 No free full text.

Abstract: BACKGROUND: For the last several years, the Department of Veterans Affairs (VA) has been involved in the development of practice guidelines for major medical, surgical, and mental disorders. This article describes the development and content of the VA-Clinical Practice Guidelines for Bipolar Disorder, which are available in their entirety on the Journal Web site (http://www. psychiatrist.com). METHOD: A multidisciplinary work group composed of content experts in the field of bipolar disorder and practitioners in general clinical practice was convened by the VA's Office of Performance and Quality and the Mental Health Strategic Health Group. The work group was instructed in algorithm development and methods of evidence evaluation. Draft guidelines were developed over the course of 6 months of meetings and conference calls, and that draft was then sent to nationally prominent content experts for final critique. RESULTS: The Bipolar Guidelines are part of the family of the VA Clinical Guidelines for Management of Persons with Psychosis and consist of explicit algorithms supplemented by annotations that explain the specific decision points and their basis in the scientific literature. The guidelines are organized into 5 modules: a Core Module for diagnosis and assignment to mood state plus 4 treatment modules (Manic/Hypomanic/Mixed Episode, Bipolar Depressive Episode, Rapid Cycling, and Bipolar Disorder With Psychotic Features). The modules specify particular diagnostic and treatment tasks at each step, including both somatotherapeutic and psychotherapeutic interventions. CONCLUSION: The VA Bipolar Guidelines are designed for easy clinical reference in decision making with individual patients, as well as for use as a scholarly reference tool. They also have utility in training activities and quality improvement programs.

Bauer MS. · Department of Psychiatry, Brown University, USA. · Essent Psychopharmacol. · Pubmed #16459754 No free full text.

Abstract: This article addresses the question of what defines a "mood stabilizer." Dr. Bauer expands upon his comprehensive 2004 review by (a) summarizing the conceptual and methodological approach to evaluating the evidence for pharmacotherapeutic options for bipolar disorder; (b) updating the evidence base from recently published controlled monotherapy trials; and (c) review the evidence base for combination therapy options. Finally, he identifies the shortcomings and sources of potential bias in our evidence base, which is critical for an accurate reading of the literature now and in the future.

Rendell JM, Gijsman HJ, Bauer MS, Goodwin GM, Geddes GR. · No affiliation provided · Cochrane Database Syst Rev. · Pubmed #16437472 No free full text.

Abstract: BACKGROUND: Risperidone, an atypical antipsychotic, is used to treat mania both alone and in combination with other medicines. OBJECTIVES: To review the efficacy and tolerability of risperidone as treatment for mania. SEARCH STRATEGY: The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR-Studies December 2004), The Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, MEDLINE, CINAHL and PsycINFO were searched in December 2004. Reference lists and English language textbooks were searched; researchers in the field and Janssen-Cilag were contacted. SELECTION CRITERIA: Randomised controlled trials comparing risperidone with placebo or other drugs in acute manic or mixed episodes. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data from trial reports. Janssen-Cilag was asked to provide missing information. QUALITY ASSESSMENT: As in other trials of treatment for mania, the high proportion of imputed efficacy data resulting from rates of failure to complete treatment of between 12% and 62% may have biased the results. MAIN RESULTS: Six trials (1343 participants) of risperidone as monotherapy or as adjunctive treatment to lithium, or an anticonvulsant, were identified. Permitted doses were consistent with those recommended by the manufacturers of Haldol (haloperidol) and Risperdal (risperidone) for treatment of mania and trials involving haloperidol allowed antiparkinsonian treatment. Risperidone monotherapy was more effective than placebo in reducing manic symptoms, using the Young Mania Rating Scale (YMRS) (weighted mean difference (WMD) -5.75, 95% confidence interval (CI) -7.46 to -4.04, P<0.00001; 2 trials) and in leading to response, remission and sustained remission. Effect sizes for monotherapy and adjunctive treatment comparisons were similar. Low levels of baseline depression precluded reliable assessment of efficacy for treatment of depressive symptoms. Risperidone as monotherapy and as adjunctive treatment was more acceptable than placebo, with lower incidence of failure to complete treatment (RR 0.66, 95% CI 0.52 to 0.82, P = 0.0003; 5 trials). Overall risperidone caused more weight gain, extrapyramidal disorder, sedation and increase in prolactin level than placebo. There was no evidence of a difference in efficacy between risperidone and haloperidol either as monotherapy or as adjunctive treatment. The acceptability of risperidone and haloperidol in incidence of failure to complete treatment was comparable. Overall risperidone caused more weight gain than haloperidol but less extrapyramidal disorder and comparable sedation. AUTHORS' CONCLUSIONS: Risperidone, as monotherapy and adjunctive treatment, is effective in reducing manic symptoms. The main adverse effects are weight gain, extrapyramidal effects and sedation. Risperidone is comparable in efficacy to haloperidol.Higher quality trials are required to provide more reliable and precise estimates of its costs and benefits.

Otto MW, Perlman CA, Wernicke R, Reese HE, Bauer MS, Pollack MH. · Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. · Bipolar Disord. · Pubmed #15541062 No free full text.

Abstract: OBJECTIVES: In this article, we review the evidence for, and implications of, a high rate of comorbid posttraumatic stress disorder (PTSD) in individuals with bipolar disorder. METHODS: We reviewed studies providing comorbidity data on patients with bipolar disorder, and also examined the PTSD literature for risk factors and empirically supported treatment options for PTSD. RESULTS: Studies of bipolar patients have documented elevated rates of PTSD. Based on our review, representing 1214 bipolar patients, the mean prevalence of PTSD in bipolar patients is 16.0% (95% CI: 14-18%), a rate that is roughly double the lifetime prevalence for PTSD in the general population. Risk factors for PTSD that are also characteristic of bipolar samples include the presence of multiple axis I disorders, greater trauma exposure, elevated neuroticism and lower extraversion, and lower social support and socio-economic status. CONCLUSIONS: These findings are discussed in relation to the cost of PTSD symptoms to the course of bipolar disorder. Pharmacological and cognitive-behavioral treatment options are reviewed, with discussion of modifications to current cognitive-behavioral protocols for addressing PTSD in individuals at risk for mood episodes.

Bauer MS, Mitchner L. · Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA. · Am J Psychiatry. · Pubmed #14702242 links to  free full text

Abstract: OBJECTIVE: The term "mood stabilizer" is widely used in the context of treating bipolar disorder, but the U.S. Food and Drug Administration (FDA) does not officially recognize the term, and no consensus definition is accepted among investigators. The authors propose a "two-by-two" definition by which an agent is considered a mood stabilizer if it has efficacy in treating acute manic and depressive symptoms and in prophylaxis of manic and depressive symptoms in bipolar disorder. They review the literature on the efficacy of agents in any of these four roles to determine which if any agents meet this definition of mood stabilizer. METHOD: The authors conducted a comprehensive review of English-language literature describing peer-reviewed, U.S. Agency for Healthcare Research and Quality class A controlled trials in order to identify agents with efficacy in any of the four roles included in their definition of a mood stabilizer. The trials were classified as positive or negative on the basis of primary outcome variables. An "FDA-like" criterion of at least two positive placebo-controlled trials was required to consider an agent efficacious. The authors also conducted a sensitivity analysis by raising and relaxing the criteria for including trials in the review. RESULTS: The authors identified 551 candidate articles, yielding 111 class A trials, including 81 monotherapy trials with 95 independent analyses published through June 2002. Lithium, valproate, and olanzapine had unequivocal evidence for efficacy in acute manic episodes, lithium in acute depressive episodes and in prophylaxis of mania and depression, and lamotrigine in prophylaxis (relapse polarity unspecified). Thus, only lithium fulfilled the a priori definition of a mood stabilizer. Relaxing the quality criterion did not change this finding, while raising the threshold resulted in no agents fulfilling the definition. CONCLUSIONS: When all four treatment roles are considered, the evidence supported a role for lithium as first-line agent for treatment of bipolar disorder. The analysis also highlights unmet needs and promising agents and provides a yardstick for evaluating new treatment strategies.

Ford DE, Pincus HA, Unützer J, Bauer MS, Gonzalez JJ, Wells KB, Anonymous00316. · Johns Hopkins University, 2024 E. Monument Street, Suite 2-500, Baltimore, Maryland 21205-2223, USA. · Ment Health Serv Res. · Pubmed #12558004 No free full text.

Abstract: Current evidence indicates there remains a large gap in the provision of depression care, particularly in primary care. Several studies have demonstrated that interventions based on the chronic disease management model can improve patient outcomes. Challenges include designing more robust interventions that can move easily into a wide variety of primary care organizations. More research is needed to develop programs to improve outcomes for children with depression and adults with bipolar disorders.

Bauer MS. · Veterans Affairs Medical Center, Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA. · Psychopharmacol Bull. · Pubmed #12397882 links to  free full text

Abstract: Because somatotherapy for bipolar disorder (BD) has led to only modest improvements in outcome in general clinical practice, increasing attention has been paid to psychosocial interventions as adjuvants to standard medical-model treatment. This article complements and extends other recent reviews of this area by (1) evaluating psychotherapy studies according to the evidence rating criteria of the Agency for Health Care Policy and Research; (2) analyzing which outcome domains are impacted by which types of psychotherapy; (3) reviewing studies of care organization (contexts of care) for BD, tracing the roots of this area from descriptions of lithium clinics in the early 1970s through the recent federally funded controlled trials; and (4) identifying a core agenda common across most psychosocial interventions. The psychotherapy literature indicates that a broad array of modalities may be effective in improving clinical outcome, functional outcome, and disease management skills, with Class A studies supporting at least some couples/partners, cognitive-behavioral, family, and psychoeducational interventions. Controlled studies of context of care interventions are in their infancy, but are built on principles similar to those used in disease management programs for chronic medical illnesses. Despite the diversity of psychosocial interventions, there is substantial convergent validity for the importance of a common agenda of a collaborative approach to illness management that includes education about the illness, and identification of patient-specific symptom patterns, and development of action plans for response to relapse. A research agenda focusing on interventions that are sustainable in general clinical practice is of the highest priority.

Callahan AM, Bauer MS. · Department of Veteran's Affairs Medical Center, Providence, Rhode Island. · Psychiatr Clin North Am. · Pubmed #10550862 No free full text.

Abstract: The limitations of pharmacotherapy and the emergence of data supporting a role for psychosocial factors in the course of bipolar disorder have led to increased interest in the use of psychosocial interventions to improve outcomes. Although this area of study has suffered from a lack of systematic data, preliminary evidence suggests that the combined use of psychosocial interventions and medication is superior to pharmacologic treatment alone. Further research is necessary to identify and the psychosocial risk factors associated with bipolar disorder to design effective interventions to diminish their effects and improve outcome. The introduction of formal, manual-based psychotherapeutic interventions that include specific educational components has been particularly promising.

Sajatovic M, Davies M, Bauer MS, McBride L, Hays RW, Safavi R, Jenkins J. · Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA. · Compr Psychiatry. · Pubmed #16175758 No free full text.

Abstract: An emerging literature suggests that a collaborative care model, in which patients are active managers of their illness within a supportive social environment, is a beneficial approach for individuals with bipolar disorder. One aspect of treatment that is often suboptimal among individuals with bipolar disorder is treatment adherence. Establishing an ideal collaborative model may offer an opportunity to enhance treatment adherence among individuals with bipolar disorder. This paper presents results from a qualitative exploration of patients' attitudes towards the collaborative care model and how individuals with bipolar disorder perceive treatment adherence within the context of the collaborative care model. All participants were actively enrolled in outpatient treatment at a Community Mental Health Center and part of a larger study that evaluated the Life Goals Program, a manual-driven structured group psychotherapy for bipolar disorder that is based on the collaborative practice model. The Life Goals Program is designed to assist individuals to participate more effectively in the management of their bipolar illness and to improve their social and work-related problems. Individuals were queried regarding their opinions on the ingredients for an effective client-provider relationship. Quantitative data were collected on baseline treatment adherence as well. Individuals treated for bipolar disorder in a community mental health clinic identified 12 key elements that they felt were critical ingredients to a positive collaborative experience with their mental health care provider. The authors conceptualized these elements around 3 emerging themes: patient-centered qualities, provider-centered qualities, and interactional qualities. Individuals with bipolar disorder perceived the ideal collaborative model as one in which the individual has specific responsibilities such as coming to appointments and sharing information, whereas the provider likewise has specific responsibilities such as keeping abreast of current "state-of-the-arf" prescribing practices and being a good listener. Treatment adherence was identified as a self-managed responsibility within the larger context of the collaborative model. Individuals with bipolar disorder in this study placed substantial emphasis on the interactional component within the patient-provider relationship, particularly with respect to times when the individual may be more symptomatic and more impaired. It is important that clinicians and care providers gather information related to patients' perceptions of the patient-provider relationship when designing or evaluating services aimed at enhancing treatment adherence.

Simon GE, Ludman EJ, Unützer J, Bauer MS, Operskalski B, Rutter C. · Center for Health Studies, Group Health Cooperative, Seattle, WA 98101, USA. · Psychol Med. · Pubmed #15842025 No free full text.

Abstract: BACKGROUND: Despite the availability of efficacious medications and psychotherapies, care of bipolar disorder in everyday practice is often deficient. This trial evaluated the effectiveness of a multi-component care management program in a population-based sample of people with bipolar disorder. METHOD: Four hundred and forty-one patients treated for bipolar disorder during the prior year were randomly assigned to continued usual care or usual care plus a systematic care management program including: initial assessment and care planning, monthly telephone monitoring including brief symptom assessment and medication monitoring, feedback to and coordination with the mental health treatment team, and a structured group psychoeducational program--all provided by a nurse care manager. Blinded quarterly assessments generated week-by-week ratings of severity of depression and mania symptoms using the Longitudinal Interval Follow-Up Evaluation. RESULTS: Participants assigned to the intervention group had significantly lower mean mania ratings averaged across the 12-month follow-up period (Z= 2.44, p=0.015) and approximately one-third less time in hypomanic or manic episode (2.59 weeks v. 1.69 weeks). Mean depression ratings across the entire follow-up period did not differ significantly between the two groups, but the intervention group showed a greater decline in depression ratings over time (Z statistic for group-by-time interaction = 1.98, p = 0.048). CONCLUSIONS: A systematic care program for bipolar disorder significantly reduces risk of mania over 12 months. Preliminary results suggest a growing effect on depression over time, but longer follow-up will be needed.

Bauer MS, Altshuler L, Evans DR, Beresford T, Williford WO, Hauger R, Anonymous00221. · VAMC and Brown University, 116R, 830 Chalkstone Avenue, Providence, RI 02908-4799, USA. · J Affect Disord. · Pubmed #15780700 No free full text.

Abstract: BACKGROUND: Recent data indicate high prevalence of both anxiety and substance comorbidity in bipolar disorder. However, few studies have utilized public sector samples, and only one has attempted to separate contributions of each type of comorbidity. METHODS: 328 inpatient veterans with bipolar disorder across 11 sites were assessed using selected Structured Clinical Interview for DSM-IV modules and self-reports. RESULTS: Comorbidity was common (current: 57.3%; lifetime: 78.4%), with multiple current comorbidities in 29.8%. Substance comorbidity rate was comparable to rates typically reported in non-veteran inpatient samples (33.8% current, 72.3% lifetime). Selected anxiety comorbidity rates exceeded those in other inpatient samples and appeared more chronic than episodic/recurrent (38.3% current, 43.3% lifetime). 49% of PTSD was due to non-combat stressors. Major correlates of current substance comorbidity alone were younger age, worse marital status, and higher current employability. Correlates of current anxiety comorbidity alone were early age of onset, greater number of prior-year depressive episodes, higher rates of disability pension receipt, and lower self-reported mental and physical function. Combined comorbidity resembled anxiety comorbidity. LIMITATIONS: This is a cross-sectional analysis of acutely hospitalized veterans. CONCLUSIONS: Distinct patterns of substance and anxiety comorbidity are striking, and may be subserved by distinct neurobiologic mechanisms. The prevalence, chronicity and functional impact of anxiety disorders indicate the need for improved recognition and treatment of this other dual diagnosis group is warranted. Clinical and research interventions should recognize these divergent comorbidity patterns and provide individualized treatment built "from the patient out."

Kogan JN, Otto MW, Bauer MS, Dennehy EB, Miklowitz DJ, Zhang HW, Ketter T, Rudorfer MV, Wisniewski SR, Thase ME, Calabrese J, Sachs GS, Anonymous00283. · Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. · Bipolar Disord. · Pubmed #15541061 No free full text.

Abstract: OBJECTIVES: Bipolar disorder is a severe, recurrent, and often highly impairing psychiatric disorder. The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) is a large-scale multicenter study funded by the National Institute of Mental Health (NIMH) to examine the longitudinal course of the disorder and the effectiveness of current treatments. The current report provides a context for interpreting studies resulting from STEP-BD by summarizing the baseline demographic and diagnostic characteristics of the first 1000 enrolled. METHODS: The majority of the sample met DSM-IV criteria for bipolar I disorder (71%). Mean age of patients was 40.6 (+/-12.7) years and mean duration of bipolar illness was 23.1 (+/-12.9) years. Among the first 1000 subjects enrolled, 58.6% are females and 92.6% Caucasian. This report compares the STEP-BD sample with other large cohorts of bipolar patients (treatment and community samples). RESULTS: Compared with US population and community studies, the first 1000 STEP-BD patients were less racially diverse, more educated, had lower income, and a higher unemployment rate. Results are discussed in terms of the contributions of STEP-BD (and other large-scale treatment studies) in understanding the nature, treatments, and outcomes of bipolar disorder for patients seeking care at academic treatment centers. CONCLUSIONS: The current report provides a context for interpreting future studies resulting from STEP-BD. The comparison of demographic and clinical characteristics between the samples across clinic-based studies suggests broad similarities despite the substantial differences in geography, payer mix, and clinical entry point.

Glick HA, Kinosian B, McBride L, Williford WO, Bauer MS, Anonymous00282. · · Bipolar Disord. · Pubmed #15541060 No free full text.

Abstract: OBJECTIVES: As part of a cost-effectiveness analysis for Department of Veterans Affairs Cooperative Studies Program #430, 'Reducing the Efficacy-Effectiveness Gap in Bipolar Disorder,' we conducted a time and motion study to quantify the time psychiatric clinical nurse specialist (CNS) care managers spent providing care for patients. METHODS: Clinical nurse specialist care managers completed activity logs in which they recorded time spent implementing the Bipolar Disorders Program (BDP) during a 1-week period in spring, summer, fall and winter over a 1-year period when caseloads were at steady state. Mean service time was estimated by use of univariate analysis of means and by multivariable regression analysis. RESULTS: On average CNS care managers spent 40% of their clinical time in activities that typically are reimbursed (e.g. clinic visits) and spent the remaining 60% of their time in activities that are typically unreimbursed. Total clinic time increased as the number of visits per day increased; however, this increase got smaller with each additional visit per day. CONCLUSIONS: As with other chronic illness management programs, CNS care managers expend a substantial portion of their clinical effort for the BDP in activities that are typically unreimbursed. Their activities have a fixed component per day as well as a component that systematically varies with the number of visits per day. These findings should be considered when costing out and disseminating psychiatric and other medical chronic illness management programs.

Ludman EJ, Simon GE, Rutter CM, Bauer MS, Unützer J. · Center for Health Studies, Group Health Cooperative, Seattle, WA 98101, USA. · Bipolar Disord. · Pubmed #12190714 No free full text.

Abstract: OBJECTIVES: Health care providers have an important role in acknowledging and supporting patients' self-management of chronic illnesses such as bipolar disorder. This report describes the development and evaluation of a brief measure for assessing patient perception of providers' support for self-management of bipolar disorder. METHODS: A 10-item measure was developed combining generic items from an existing measure of providers' autonomy supportive versus controlling style with items specific to the self-management of bipolar disorder. The psychometric properties of the measure and its relation to clinical variables were evaluated in a sample of patients enrolled in an ongoing randomized intervention trial. RESULTS: Data were obtained from 420 patients with a chart diagnosis of bipolar disorder (mean age=44, 68% female, 88% Caucasian). The proportion of missing responses for items ranged from 0 to 3%. Reliability coefficient alpha for the full scale was 0.94. Corrected item-total correlations for individual items ranged from 0.70 to 0.83. Factor analysis identified a single factor accounting for 67% of total variance. Factor loadings for individual items were all at least 0.75. The measure showed moderate positive correlations with measures of self-efficacy for managing bipolar disorder (r=0.34; p < 0.001), treatment satisfaction (r=0.63; p < 0.001), small negative correlations with measures of mania symptoms (r=-0.11; p < 0.03) and depressive symptoms (r=-0.09; p < 0.10). CONCLUSIONS: This measure shows good psychometric properties and good evidence for convergent and discriminant validity. It is promising for assessing an important aspect of care for bipolar disorder.

Simon GE, Ludman E, Unützer J, Bauer MS. · Center for Health Studies, Group Health Cooperative, Seattle, WA 98101, USA. · Bipolar Disord. · Pubmed #12190711 No free full text.

Abstract: OBJECTIVES: Everyday care of bipolar disorder typically falls short of evidence-based practice. This report describes the design and implementation of a randomized trial evaluating a systematic program to improve quality and continuity of care for bipolar disorder. METHODS: Computerized records of a large health plan were used to identify all patients treated for bipolar disorder. Following a baseline diagnostic assessment, eligible and consenting patients were randomly assigned to either continued usual care or a multifaceted intervention program including: development of a collaborative treatment plan, monthly telephone monitoring by a dedicated nurse care manager, feedback of monitoring results and algorithm-based medication recommendations to treating mental health providers, as-needed outreach and care coordination, and a structured psychoeducational group program (the Life Goals Program by Bauer and McBride) delivered by the nurse care manager. Blinded assessments of clinical outcomes, functional outcomes, and treatment process were conducted every 3 months for 24 months. RESULTS: A total of 441 patients (64% of those eligible) consented to participate and 43% of enrolled patients met criteria for current major depressive episode, manic episode, or hypomanic episode. An additional 39% reported significant subthreshold symptoms, and 18% reported minimal or no current mood symptoms. Of patients assigned to the intervention program, 94% participated in telephone monitoring and 70% attended at least one group session. CONCLUSIONS: In a population-based sample of patients treated for bipolar disorder, approximately two-thirds agreed to participate in a randomized trial comparing alternative treatment strategies. Nearly all patients accepted regular telephone monitoring and over two-thirds joined a structured group program. Future reports will describe clinical effectiveness and cost-effectiveness of the intervention program compared with usual care.

Bauer MS. · Veterans Affairs Medical Center, Brown University, Providence, Rhode Island 02908-4799, USA. · Bipolar Disord. · Pubmed #11903206 No free full text.

Abstract: Bipolar disorder remains a high morbidity and costly illness in general clinical practice, despite the availability of efficacious medications. This 'efficacy-effectiveness gap' may be addressed by better organizing systems of care. One type of intervention is the 'collaborative practice model' which can be defined as an organization of care that a) emphasizes development in the patient of illness management skills, and b) supports provider capability and availability in order to c) engage patients in timely, joint decision-making regarding their illness. This article describes such a collaborative practice model for bipolar disorder, designed to be widely adoptable and sustainable in general clinical practice. The first part of the article describes the theoretical background from which the collaborative practice approach developed, emphasizing its origins in the lithium clinics of the 1970s, in nursing theory and practice, and more recently in the management of chronic medical diseases. The second part describes the structure of one such intervention, the Bipolar Disorders Program (BDP) developed in the Veterans Affairs health care system. The third part summarizes results from single-site studies of the intervention. The fourth part describes several key issues in its implementation in an ongoing multi-site randomized controlled trial, VA Cooperative Study Program (CSP) # 430. Data to date indicate that such collaborative practice interventions may improve important process and intermediate outcome variables for bipolar disorder. The BDP provides an example of a multi-faceted collaborative practice model that can be manualized and implemented across multiple sites in a randomized controlled trial.

Bauer MS, Williford WO, Dawson EE, Akiskal HS, Altshuler L, Fye C, Gelenberg A, Glick H, Kinosian B, Sajatovic M. · Providence VA Medical Center, Providence, RI, USA. · J Affect Disord. · Pubmed #11869753 No free full text.

Abstract: Despite the availability of efficacious treatments for bipolar disorder, their effectiveness in general clinical practice is greatly attenuated, resulting in what has been called an 'efficacy-effectiveness gap'. In designing VA Cooperative Studies Program (CSP) Study #430 to address this gap, nine principles for conducting an effectiveness (in contrast to an efficacy) study were identified. These principles are presented and discussed, with specific aspects of CSP #430 serving as illustrations of how they can be implemented in an actual study. CSP #430 hypothesizes that an integrated, clinic-based treatment delivery system that emphasizes (1) algorithm-driven somatotherapy, (2) standardized patient education, and (3) easy access to a single primary mental health care provider to maximize continuity-of-care, will address the efficacy-effectiveness gap and improve disease, functional, and economic outcome. It is an 11-site, randomized controlled clinical trial of this multi-modal, clinic-based intervention versus usual VA care running from 1997 to 2003. The trial has enrolled 191 subjects in each arm, using minimal exclusion criteria to maximize the external validity of the study. Subjects are followed for 3 years. The intervention is highly specified in a series of operations manuals for each of the three components. Several continuous quality improvement (CQI) interventions, process measures, and statistical techniques deal with drift of care in both the intervention and usual care arms to ensure the internal validity of the study. CSP #430 is designed to have impact well beyond the VA, since it evaluates a basic health care operational principle: that augmenting ambulatory access for major mental illness will improve outcome and reduce overall treatment costs. If results are positive, this study will provide a reason to reconsider the prevailing trend toward limitation of ambulatory services that is characteristic of many managed care systems today.

Zeber JE, Copeland LA, McCarthy JF, Bauer MS, Kilbourne AM. · Veterans Affairs Health Service Research & Development (Center, San Antonio, TX 78229, USA. · Am J Public Health. · Pubmed #19150912 No free full text.

Abstract: OBJECTIVES: We examined associations between patient characteristics and self-reported difficulties in accessing mental health and general medical care services. METHODS: Patients were recruited from the Continuous Improvement for Veterans in Care-Mood Disorders study. We used multivariable logistic regression analyses to assess whether predisposing (demographic characteristics), enabling (e.g., homelessness), or need (bipolar symptoms, substance abuse) factors were associated with difficulties in obtaining care, difficulties in locating specialty providers, and forgoing care because of cost. RESULTS: Patients reported greater difficulty in accessing general medical services than in accessing psychiatric care. Individuals experiencing bipolar symptoms more frequently avoided psychiatric care because of cost (odds ratio [OR] = 2.43) and perceived greater difficulties in accessing medical specialists (OR = 2.06). Homeless individuals were more likely to report hospitalization barriers, whereas older and minority patients generally encountered fewer problems accessing treatment. CONCLUSIONS: Need and enabling factors were most influential in predicting self-reported difficulties in accessing care, subsequently interfering with treatment dynamics and jeopardizing clinical outcomes. Efforts in the Department of Veterans Affairs to expand mental health care access should be coupled with efforts to ensure adequate access to general medical services among patients with chronic mental illnesses.

Gyulai L, Bauer MS, Marangell LB, Dennehy EB, Thase ME, Otto MW, Zhang H, Wisniewski SR, Miklowitz DJ, Rapaport MH, Baldassano CF, Sachs GS. · Bipolar Disorders Program, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA. · Psychopharmacol Bull. · Pubmed #19015629 No free full text.

Abstract: Objectives: Our primary aim was to describe unique correlates of functioning in bipolar disorder (BD). Experimental Design: The study included the first 500 patients enrolled in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Patients were 41.9 +/- 12.7 years old, and diagnosed with bipolar I, II or NOS, verified by structured interview. Overall functionality was determined by the Range of Impaired Function Tool (LIFE-RIFT). Stepwise multiple regression analysis tested the non-redundant-independent-association of 28 variables on functioning. Principal Observations: Severity of depression symptoms was significantly and uniquely correlated with impaired functioning in the context of a wide variety of demographic and clinical variables, contributing 60.9% to the total variance in overall functioning (ss = 0.254, p = 0.0001). Substantial variance in function remains unexplained. Conclusions: Intensity of depressive symptoms is the major determinant of impaired functioning in bipolar disorder, but longitudinal analyses may further explain the substantial variance in function not explained by this large and comprehensive model. Treatments and outcome assessment for patients with bipolar disorders should consider both functional and symptomatic change.

Pirraglia PA, Biswas K, Kilbourne AM, Fenn H, Bauer MS. · Providence VA Medical Center and the Warren Alpert Medical School of Brown University, United States. · J Affect Disord. · Pubmed #18930558 No free full text.

Abstract: BACKGROUND: Several studies suggest that medical comorbidity is associated with worse clinical status in bipolar disorder. It is unclear which aspect of medical comorbidity is responsible: simple disease count, risk for future morbidity, or current physical burden. METHODS: We analyzed three years of prospective data from a randomized clinical trial of collaborative care in 306 bipolar veterans. We examined the association of clinical outcome with baseline medical comorbidity defined as: (1) simple active disease count, (2) diseases with risk for future morbidity measured with the Charlson Comorbidity Index, and (3) current physical burden measured with the SF-36 Physical Component Summary score (PCS). Bipolar outcomes were weeks in episode, mean depression score, and change in mental health burden measured by the SF-36 Mental Component Summary score (MCS). RESULTS: The three medical comorbidity measures were not highly correlated, indicating that each conveyed novel information. Controlling for potential confounders, worse baseline PCS predicted significantly higher mean depression scores (p=0.011) and less improvement in MCS scores (p=0.0099) over three years. Simple disease count and risk for future risk did not predict worse bipolar outcomes. LIMITATIONS: Some potential limitations include not accounting for all confounding factors, selection bias for participants, increased the likelihood of Type I error due to multiple comparisons and having a predominantly male population. CONCLUSIONS: This long-term prospective study extends cross-sectional and retrospective research on the link between medical illness and bipolar outcomes. It is the current experience of burden of physical illness, rather than an unweighted or weighted disease count, that leads to worse bipolar outcomes.

Simon GE, Ludman EJ, Unützer J, Operskalski BH, Bauer MS. · Center for Health Studies, Group Health Cooperative, Seattle, WA 98101, USA. · Bipolar Disord. · Pubmed #18837866 No free full text.

Abstract: OBJECTIVE: To evaluate the relationship between mood symptoms and work productivity in people with bipolar disorder. METHODS: A total of 441 outpatients treated for bipolar disorder were enrolled from mental health clinics of a health plan in Washington State. A baseline assessment included confirmation of diagnosis (using the Structured Clinical Interview for DSM-IV) as well as assessment of employment status, functional impairment, and days missed from work. Eight follow-up interviews over 24 months included self-reported employment status, self-reported days missed from work due to illness, and assessment of current and interval mood symptoms using the Longitudinal Interval Follow-up Examination. RESULTS: Averaged over four assessments, patients with current major depression were 15% less likely to be employed than those without significant depressive symptoms [odds ratio (OR) = 0.84, 95% confidence interval (CI): 0.76-0.92]. Manic or hypomanic symptoms were not significantly associated with probability of employment (OR = 0.93, CI: 0.83-1.04). Among those employed, major depression was associated with 4.06 additional days of work missed per month (CI: 1.05-7.06) compared to those without significant depressive symptoms. Meeting criteria for manic or hypomanic episode was associated with a similar number of missed work days, but this difference was not statistically significant (adjusted difference = 4.11 days, CI: -0.18-8.40). CONCLUSIONS: Among patients with bipolar disorder, depression is strongly and consistently associated with decreased probability of employment and more days missed from work due to illness. Symptoms of mania or hypomania have more variable effects on work productivity.

Kilbourne AM, Post EP, Nossek A, Sonel E, Drill LJ, Cooley S, Bauer MS. · VA Ann Arbor National Serious Mental Illness Treatment Research and Evaluation Center, Ann Arbor, MI 48105, USA. · Bipolar Disord. · Pubmed #18837861 No free full text.

Abstract: OBJECTIVES: Medical comorbidities, especially cardiovascular disease (CVD), occur disproportionately in older patients with bipolar disorder. We describe the development, implementation, and feasibility/tolerability results of a manual-based medical care model (BCM) designed to improve medical outcomes in older patients with bipolar disorder. METHODS: The BCM consisted of (i) self-management sessions focused on bipolar disorder symptom control, healthy habits, and provider engagement, (ii) telephone care management to coordinate care and reinforce self-management goals, and (iii) guideline dissemination focused on medical issues in bipolar disorder. Older patients with bipolar disorder and a CVD-related risk factor (n = 58) were consented, enrolled, and randomized to receive BCM or usual care. RESULTS: Baseline assessment (mean age = 55, 9% female, 9% African American) revealed a vulnerable population: 21% were substance users, 31% relied on public transportation, and 22% reported problems accessing medical care. Evaluation of BCM feasibility revealed high overall patient satisfaction with the intervention, high fidelity (e.g., majority of self-management sessions and follow-up contacts completed), and good tolerability (dropout rate <5%). Use of telephone contacts may have mitigated barriers to medical care (e.g., transportation). CONCLUSIONS: The BCM is a feasible model for older, medically ill patients with bipolar disorder, and could be an alternative to more costly treatment models that involve co-location and/or additional hiring of medical providers in mental health clinics. Future research directions pertinent to the development of the BCM and other medical care models for older patients with bipolar disorder include assessment of their long-term effects on physical health and their cost-effectiveness across different treatment settings.

Ilgen MA, Czyz EK, Welsh DE, Zeber JE, Bauer MS, Kilbourne AM. · Department of Veterans Affairs, Health Services Research and Development and VA National Serious Mental Illness Treatment Research and Evaluation Center, Ann Arbor, MI, United States. · J Affect Disord. · Pubmed #18774179 No free full text.

Abstract: BACKGROUND: A diagnosis of Bipolar Disorder (BD) is among the strongest known risk factors for suicide. The present study examines the relative impact of current mood state (depressed, manic or mixed) and patient perceptions of the therapeutic relationship on suicidal ideation in veterans with BD. METHODS: We conducted analyses of the baseline data from a naturalistic cohort study of veterans receiving care for BD (N=432) at a large urban VA mental health clinic. Logistic regression was used to examine the relative impact of patient- and treatment-related factors on suicidal ideation within the two weeks prior to recruitment. RESULTS: Over 49% (213/432) of veterans receiving current outpatient treatment for BD reported at least some suicidal ideation within the two weeks prior to recruitment. After accounting for current mood state and other identified risk factors, even minimal increases (i.e., per point increase on a 0-60 rating scale) in the extent to which the therapeutic relationship is perceived as collaborative (OR=0.97; p<.01) were associated with a reduction in risk of suicidal ideation. LIMITATIONS: This study is cross sectional and relies exclusively on patient self-report. CONCLUSIONS: Mental health treatment providers should be aware of the high rate of suicidal ideation in patients with BD. Successful management of suicidal ideation likely involves a focus on improving symptoms as well as establishing a collaborative therapeutic relationship.

Marangell LB, Dennehy EB, Miyahara S, Wisniewski SR, Bauer MS, Rapaport MH, Allen MH. · Mood Disorders Center, Menninger Department of Psychiatry, Baylor College of Medicine, Houston, TX, United States. · J Affect Disord. · Pubmed #18708263 No free full text.

Abstract: BACKGROUND: This report describes baseline characteristics and functional outcomes of subjects who have prospectively observed subsyndromal symptoms after a major depressive episode (MDE). METHODS: All subjects were participants in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). We identified subjects with at least 2 years of observation whose prior or current episode was a MDE, and who were in a stable clinical state of either recovered (no more than 2 moderate symptoms for at least 8 weeks), a MDE by DSM-IV criteria, or with continued subsyndromal symptoms. The subsyndromal group was defined a priori as 3 or more moderate affective symptoms but without meeting diagnostic criteria for major depression. RESULTS: The final cohort included 1094 recovered, 112 subsyndromal, and 310 individuals in a MDE. The average time spent in each clinical status ranged from 120 to 132 days. The subsyndromal group was most similar to those in a MDE, differing only on the intensity of depressive symptoms and the number of work days missed due to ongoing symptoms. Reported sadness, inability to feel and lassitude were each associated with multiple measures of impairment. LIMITATIONS: This study is limited by the cross-sectional approach to defining outcomes. CONCLUSIONS: These findings are consistent with studies in unipolar major depression that indicate that functional impairment observed in the context of subsyndromal depressive symptoms is comparable to that of a full episode. This work underscores the need to include subsyndromal symptoms in study outcomes and to target full remission in clinical practice.

Kilbourne AM, Post EP, Nossek A, Drill L, Cooley S, Bauer MS. · Serious Mental Illness Treatment Research and Evaluation Center, Health Services Research and Development, Department of Veterans Affairs Ann Arbor, Ann Arbor, MI 48105, USA. · Psychiatr Serv. · Pubmed #18586993 links to  free full text

Abstract: OBJECTIVES: Comorbid medical conditions, notably cardiovascular disease, occur disproportionately among persons with bipolar disorder; yet the quality and outcomes of medical care for these individuals are suboptimal. This pilot study examined a bipolar disorder medical care model (BCM) and determined whether, compared with usual care, individuals randomly assigned to receive BCM care had improved medical and psychiatric outcomes. METHODS: Persons with bipolar disorder and cardiovascular disease-related risk factors were recruited from a large Department of Veterans Affairs mental health facility and randomly assigned to receive BCM or usual care. BCM care consisted of four self-management sessions on bipolar disorder symptom control strategies, education and behavioral change related to cardiovascular disease risk factors, and promotion of provider engagement. Primary outcomes were physical and mental health-related quality of life; secondary outcomes included functioning and bipolar symptoms. RESULTS: Fifty-eight persons participated. Twenty-seven received BCM care, and 31 received usual care. The mean+/-SD age was 55+/-8 years, 9% were female, 90% were white, and 10% were African American. Repeated-measures analysis was used, and significant differences were observed between the two groups in change in scores from baseline to six months for the 12-Item Short-Form Health Survey (SF-12) subscale for physical health (t=2.01, df=173, p=.04), indicating that the usual care group experienced a decline in physical health over the study period. Change in SF-12 scores also indicated that compared with the usual care group, the BCM group showed improvements in mental health-related quality of life over the six-month study period; however, this finding was not significant. CONCLUSIONS: Compared with usual care, BCM care may have slowed the decline in physical health-related quality of life. Further studies are needed to determine whether BCM care leads to long-term positive changes in physical and mental health-related quality of life and reduced risk of cardiovascular disease among persons with bipolar disorder.