A qualitative assessment of cross-cultural adaptation of intermediate measures for schizophrenia in multisite international studies.

In this substudy of the Measurement and Treatment Research to Improve Cognition in Schizophrenia we examined qualitative feedback on the cross-cultural adaptability of four intermediate measures of functional outcome (Independent Living Scales, UCSD Performance-Based Skills Assessment, Test of Adaptive Behavior in Schizophrenia, and Cognitive Assessment Interview). Feedback was provided by experienced English-fluent clinical researchers at 31 sites in eight countries familiar with medication trials. Researchers provided feedback on test subscales and items which were rated as having adaptation challenges. They noted the specific concern and made suggestions for adaptation to their culture. We analyzed the qualitative data using a modified Grounded Theory approach guided by the International Testing Commission Guidelines model for test adaptation. For each measure except the Cognitive Assessment Interview (CAI), the majority of subscales were reported to require major adaptations in terms of content and concepts contained in the subscale. In particular, social, financial, transportation and health care systems varied widely across countries-systems which are often used to assess performance capacity in the U.S. We provide suggestions for how to address future international test development and adaptation.

Community mental health agency views of research.

We examined community mental health center staff perceptions of ongoing research within their agency. We interviewed upper management and conducted focus groups with medical staff, non-medical clinicians, and administrative staff. Participants were asked about (1) their attitudes towards research in general, agency research and towards the principal academic institution doing research with clients, (2) their perceptions of the value of research and (3) ideas for improving the collaboration. We identified 5 overarching themes: inter-agency communication, shared goals and equality in research, researchers adding knowledge to the agency, improving attitudes toward research, and agency involvement in research. Under these domains, specific suggestions are made for how to improve the collaboration across all stakeholder groups. Lack of shared values and inadequate communication processes can negatively impact community-based research collaborations. However, clear strategies, and adequate resources have great potential to improve community mental health collaborations.

Review of the safety, efficacy, and side effect profile of asenapine in the treatment of bipolar 1 disorder.

OBJECTIVE: Asenapine is approved for acute manic and mixed states in bipolar disorder. The objective is to review the efficacy of asenapine in bipolar disorder, with a particular focus on acceptability and adherence to treatment. METHODS: FIVE CLINICAL TRIALS WERE CONDUCTED IN BIPOLAR DISORDER MANIC OR MIXED STATES: two 3-week trials (n = 976) comparing asenapine to placebo, a 9-week extension (n = 504), and a 40-week extension (n = 107). One trial was conducted comparing asenapine to placebo (n = 326) as adjunctive therapy for subjects with an incomplete response to lithium or valproate. All trials were conducted in the USA and internationally. RESULTS: Asenapine was found to be efficacious for manic and mixed states in bipolar disorder compared with placebo control, and compares equally well to olanzapine on efficacy measures after 3 weeks of treatment. Asenapine was not found to be efficacious for depression symptoms. Common asenapine side effects in the 40-week extension trial were sedation, insomnia, and dizziness, and 31% reported clinically significant weight gain, compared with 55% reporting clinically significant weight gain with olanzapine. Additionally, 18% had clinically significant changes in fasting blood glucose levels compared to 22% of those on olanzapine. In terms of patient acceptability, one concern may be sublingual administration requiring no liquids or food for 10 minutes after dosing and a twice-daily regimen. Suggestions about addressing barriers to adherence and acceptability are provided. CONCLUSION: Asenapine is a promising new medication in bipolar disorder. Asenapine in the long-term has a more favorable weight gain profile compared to olanzapine. No benefit was seen for depression symptoms, a major patient-reported concern. Some side effects do not remit after the short-term trials in at least 10% of patients.

Psychiatric and medical admissions observed among elderly patients with new-onset epilepsy.

BACKGROUND: Inpatient utilization associated with incidence of geriatric new-onset epilepsy has not been characterized in any large study, despite recognized high levels of risk factors (comorbidity). METHODS: Retrospective study using administrative data (Oct '01-Sep '05) from the Veterans Health Administration from a nationwide sample of 824,483 patients over age 66 in the retrospective observational Treatment In Geriatric Epilepsy Research (TIGER) study. Psychiatric and medical hospital admissions were analyzed as a function of patient demographics, comorbid psychiatric, neurological, and other medical conditions, and new-onset epilepsy. RESULTS: Elderly patients experienced a 15% hospitalization rate in FY00 overall, but the subset of new-onset epilepsy patients (n = 1,610) had a 52% hospitalization rate. New-onset epilepsy was associated with three-fold increased relative odds of psychiatric admission and nearly five-fold increased relative odds of medical admission. Among new-onset epilepsy patients, alcohol dependence was most strongly associated with psychiatric admission during the first year after epilepsy onset (odds ratio = 5.2; 95% confidence interval 2.6-10.0), while for medical admissions the strongest factor was myocardial infarction (odds ratio = 4.7; 95% confidence interval 2.7-8.3). CONCLUSION: From the patient point of view, new-onset epilepsy was associated with an increased risk of medical admission as well as of psychiatric admission. From an analytic perspective, omitting epilepsy and other neurological conditions may lead to overestimation of the risk of admission attributable solely to psychiatric conditions. Finally, from a health systems perspective, the emerging picture of the epilepsy patient with considerable comorbidity and demand for healthcare resources may merit development of practice guidelines to improve coordinated delivery of care.

How the relationship of attitudes toward mental health treatment and service use differs by age, gender, ethnicity/race and education.

BACKGROUND: Promoting help-seeking for mental health problems can result in improved treatment rates. For the most impact, social marketing interventions need to be tailored to targeted demographic subgroups. We investigated the influence of interactions between attitudes toward treatment and age, gender, ethnicity/race and education for both general medical and specialty care. METHOD: Cross-sectional data from the 2001-2003 National Comorbidity Survey Replication (NCS-R) were analyzed using multivariate models adjusted for the sampling design and controlled for relevant clinical and sociodemographic factors. RESULTS: Greater comfort talking to a professional was associated with greater past-year specialty care across all demographic groups, while strongest for non-Latino whites and not evident for those 50-64 years old. For all demographic groups, reported willingness to seek professional help was associated with general medical care. However, for specialty care the association was much stronger for men compared to women. For African Americans, but not non-Latino whites, the perceived efficacy of mental health treatment improved the likelihood of past-year specialty use. CONCLUSION: Our analyses suggest both the importance of understanding demographic differences in relevant attitudes and potential directions for marketing campaigns.

Public-academic partnerships: tools for mental health agencies to evaluate research protocols.

Research involving community mental health center clients, resources, or both can affect clinical care, administrative processes, and costs. To help agencies identify and quantify these effects, a stakeholder group examined and discussed a range of protocols and then developed questionnaires and rating scales for agency use. The purpose of these materials is to make explicit the risks, costs, and benefits of a research protocol so an agency can make informed decisions about protocol approval and implementation. The goal of this work was to promote the conduct of appropriate research in community mental health settings while reducing risks to the agency and its clientele.

One-year treatment outcomes of African-American and Hispanic patients with bipolar I or II disorder in STEP-BD.

OBJECTIVE: Few studies have compared treatment outcomes of African-American, Hispanic, and non-Hispanic white patients with bipolar disorder. The U.S. Systematic Treatment Enhancement Program for Bipolar Disorder compared one-year outcomes for bipolar I or II disorder from each of these racial-ethnic groups. METHODS: African Americans (N=155) were retrospectively compared with a matched group of non-Hispanic whites (N=729), and Hispanics (N=152) were compared with a separate matched group of non-Hispanic whites (N=822). Response and recovery outcomes were examined. Survival analysis was used to compare time to treatment response for depression (Montgomery-Asberg Depression Rating Scale) and mania (Young Mania Rating Scale) as well as global assessment of functioning (Global Assessment of Functioning). RESULTS: For manic and depressive symptoms, time to response and proportion of responders were similar across groups. Over the study year the proportion of days well was similar across groups. A smaller proportion of African Americans met criteria for improved global functioning. Depression response among African Americans with psychotic symptoms was slower than the response among African Americans without psychotic symptoms and among non-Hispanic whites with or without psychotic symptoms. No differences between Hispanics and non-Hispanic whites in response times and recovery were observed. CONCLUSIONS: Results are consistent with U.S. clinical trials for other psychiatric disorders, which have reported similar outcomes for ratings of primary symptoms. Baseline psychotic symptoms are likely a significant contributor when African Americans with bipolar disorder are slow to recover. These results may be less generalizable to uninsured patients.

Principal domains of behavioral psychopathology identified by the Bipolar Inventory of Signs and Symptoms Scale (BISS).

Current symptom rating scales and diagnostic categories for bipolar disorder (BD) do not provide dimensional profiles of the types of behavior disturbed in this complex disorder. To overcome these limitations we identified the principal domains of behavioral symptomatology in bipolar individuals, including all mood states, and used a more comprehensive rating scale for BD: the Bipolar Inventory of Signs and Symptoms Scale (BISS). A total of 246 patients with BD (196 with BD type I, and 50 with BD type II) were interviewed using the BISS. Exploratory factor analysis was performed on the BISS results using the maximum likelihood factor extraction method, followed by oblique rotation of the extracted factor loadings. We determined the strength of relationships between factor scores using the Pearson correlation coefficient. The following five factors were extracted: mania, depression, irritability, anxiety and psychosis. Anxiety was significantly correlated with depression and irritability. The mania factor score was only weakly associated with the other four factors. The domains of the BISS capture both the historical categories of depression and mania, plus irritability, psychosis, and an additional principal domain, anxiety. Despite the common occurrence of anxiety in BD, it has not been identified in most prior factor analyses, in part due to limited coverage of anxiety symptoms in the source scales.

Suicidal ideation and depressive symptoms among bipolar patients as predictors of the health and well-being of caregivers.

OBJECTIVES: Few studies have addressed the physical and mental health effects of caring for a family member with bipolar disorder. This study examined whether caregivers' health is associated with changes in suicidal ideation and depressive symptoms among bipolar patients observed over one year. METHODS: Patients (N = 500) participating in the Systematic Treatment Enhancement Program for Bipolar Disorder and their primary caregivers (N = 500, including 188 parental and 182 spousal caregivers) were evaluated for up to one year as part of a naturalistic observational study. Caregivers' perceptions of their own physical health were evaluated using the general health scale from the Medical Outcomes Study 36-item Short-Form Health Survey. Caregivers' depression was evaluated using the Center for Epidemiological Studies of Depression Scale. RESULTS: Caregivers of patients who had increasing suicidal ideation over time reported worsening health over time compared to caregivers of patients whose suicidal ideation decreased or stayed the same. Caregivers of patients who had more suicidal ideation and depressive symptoms reported more depressed mood over a one-year reporting period than caregivers of patients with less suicidal ideation or depression. The pattern of findings was consistent across parent caregivers and spousal caregivers. CONCLUSIONS: Caregivers, rightly concerned about patients becoming suicidal or depressed, may try to care for the patient at the expense of their own health and well-being. Treatments that focus on the health of caregivers must be developed and tested.

Medical comorbidity among youth diagnosed with bipolar disorder in the United States.

OBJECTIVE: This study examines the number and type of medical comorbidities among youth diagnosed with bipolar disorder. METHOD: This is a retrospective data analysis using the 2000-2001 Thomson Medstat MarketScan medical claims and administrative files. The population included a national sample of youth (ages 6-18 years) from privately insured families within the United States. Number of chronic medical conditions and type of medical comorbidity were analyzed in ICD-10-diagnosed youth with bipolar disorder (N = 832) and other types of psychiatric disorders (N = 21,493) using The Johns Hopkins Adjusted Clinical Groups Case Mix System, Version 8.0. RESULTS: Thirty-six percent of youth with bipolar disorder had 2 or more chronic health conditions versus 8% of youth with other psychiatric diagnoses. The following categories of medical conditions were significantly more prevalent in youth diagnosed with bipolar disorder: cardiology, gastrointestinal/hepatic, neurologic, musculoskeletal, female reproductive, and respiratory. Toxic effects and adverse events were also higher in youth with bipolar disorder, compared to youth with other psychiatric disorders. CONCLUSIONS: Youth with bipolar disorder experience higher rates of several medical illnesses compared to youth with other psychiatric diagnoses. Several factors may explain this phenomenon, including worse medication side effects, unhealthy lifestyle behaviors, poorer access to health care services, socioeconomic status, and biologic susceptibility. Moreover, a diagnosis of bipolar disorder may reflect more frequent health care utilization and therefore more opportunities for additional medical diagnoses. Further understanding regarding reasons for these relatively high rates of comorbidity among youth diagnosed with bipolar disorder may be helpful in improving overall health and quality of life during the early stages/onset of this disorder.

Increasing minority research participation through collaboration with community outpatient clinics: the STEP-BD Community Partners Experience.

BACKGROUND: Minority populations have been under-represented in mental health research studies. The systematic treatment enhancement program for bipolar disorder developed the Community Partners Program (CPP) to address this issue in a large, prospective treatment study of persons with bipolar disorder. PURPOSE: The primary goal of CPP was to develop a community-based infrastructure for studying bipolar disorder that would enhance the ethnic/racial and socioeconomic diversity of participants. METHODS: Selected academic sites partnered with local clinics (n = 6 partnerships in five cities). This report describes the conceptualization, implementation, and qualitative evaluation of CPP, as well as quantitative analysis of clinical and sociodemographic differences between the samples recruited at academic versus community sites. RESULTS: Quantitative analysis of the 155 participants from the six partnerships revealed enrollment of 45% from minority populations (vs. 15% in academic sites). Significant sociodemographic differences were evident not only between academic and community sites, but within minority and non-minority groups across site types. Notably, clinical differences were not evident between participants from academic and community sites. Review of qualitative data suggests that certain factors around implementation of research protocols may enhance community participation. CONCLUSIONS: Moving research recruitment and participation into community sites was more successful in increasing minority enrollment than efforts to attract such individuals to academic sites. Recommendations for creating and maintaining academic/community partnerships are given. LIMITATIONS: Several important variables were not considered including mood severity, hospitalization, or treatment differences. Minority participants were grouped by combining African American and Hispanics, which may have obscured subgroup differences. A derivation of standard qualitative methods was used in this study.

Public-academic partnerships: research in community mental health settings: a practicum experience for researchers.

Applying research findings to community mental health practices is slowed by provider concerns that research participants often differ from community populations in duration of illness, comorbid conditions, and illness severity. Selecting participants from community settings makes research results demonstrably relevant, but researchers and community providers can be mistrustful of one another, feeling that the other has little understanding of their needs and work. This mistrust impedes patient referrals for research. This column describes a program to increase researcher knowledge of community clinic procedures through structured interactions with clinic personnel. Follow-up interviews indicate improved attitudes and cooperation of researchers and community providers.

Development of the Bipolar Inventory of Symptoms Scale: concurrent validity, discriminant validity and retest reliability.

Scales used in studies of bipolar disorder have generally been standardized with major depressive or hospitalized manic patients. A clinician rated scale based on a semi-structured interview for persons with bipolar disorder, with comprehensive coverage of bipolar symptomatology, is needed. We report concurrent, divergent and convergent psychometric reliability, discriminant validity and relationship to a measure of overall function for a new psychometric rating instrument. A primarily outpatient sample of 224 subjects was assessed using the Bipolar Inventory of Symptoms Scale (BISS). The BISS total score and depression and mania subscales were compared to the Young Mania Rating Scale (YMRS), the Montgomery Asberg Depression Rating Scale (MADRS) and the Global Assessment of Functioning Scale (GAF). Clinical mood states were also compared using the BISS. The BISS scores demonstrated good concurrent validity, with estimates (Pearson correlations) ranging from 0.74 to 0.94 for YMRS and MADRS and test-retest reliability from 0.95 to 0.98. BISS concurrent validity with the GAF was significant for four clinical states, but not mixed states. The BISS discriminated primary bipolar mood states as well as subjects recovered for eight weeks compared to healthy controls. In conclusion, the BISS is a reliable and valid instrument broadly applicable in clinical research to assess the comprehensive domains of bipolar disorder. Future directions include factor analysis and sensitivity to change from treatment studies.

Rehabilitation and recovery in schizophrenia.

The combination of new medications and effective psychosocial rehabilitation interventions has the potential to improve outcomes for individuals with schizophrenia significantly. Patients who have persistent positive symptoms can benefit from cognitive behavior therapy. Impairments in social competence can be addressed with social skills training. Supported employment programs may increase the ability of patients who have schizophrenia to obtain competitive employment. Family psychoeducational approaches, treatments for comorbid substance abuse, and cognitive rehabilitation approaches that enhance or bypass impairments in cognitive functioning are discussed. This article describes current efforts to incorporate these evidence-based principles of rehabilitative medicine into the management of schizophrenia.

Intensive psychosocial intervention enhances functioning in patients with bipolar depression: results from a 9-month randomized controlled trial.

OBJECTIVE: Psychosocial interventions are effective adjuncts to pharmacotherapy in delaying recurrences of bipolar disorder; however, to date their effects on life functioning have been given little attention. In a randomized trial, the authors examined the impact of intensive psychosocial treatment plus pharmacotherapy on the functional outcomes of patients with bipolar disorder over the 9 months following a depressive episode. METHOD: Participants were 152 depressed outpatients with bipolar I or bipolar II disorder in the multisite Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study. All patients received pharmacotherapy. Eighty-four patients were randomly assigned to intensive psychosocial intervention (30 sessions over 9 months of interpersonal and social rhythm therapy, cognitive behavior therapy [CBT], or family-focused therapy), and 68 patients were randomly assigned to collaborative care (a 3-session psychoeducational treatment). Independent evaluators rated the four subscales of the Longitudinal Interval Follow-Up Evaluation-Range of Impaired Functioning Tool (LIFE-RIFT) (relationships, satisfaction with activities, work/role functioning, and recreational activities) through structured interviews given at baseline and every 3 months over a 9-month period. RESULTS: Patients in intensive psychotherapy had better total functioning, relationship functioning, and life satisfaction scores over 9 months than patients in collaborative care, even after pretreatment functioning and concurrent depression scores were covaried. No effects of psychosocial intervention were observed on work/role functioning or recreation scores during this 9-month period. CONCLUSIONS: Intensive psychosocial treatment enhances relationship functioning and life satisfaction among patients with bipolar disorder. Alternate interventions focused on the specific cognitive deficits of individuals with bipolar disorder may be necessary to enhance vocational functioning after a depressive episode.

Psychosocial treatments for bipolar depression: a 1-year randomized trial from the Systematic Treatment Enhancement Program.

CONTEXT: Psychosocial interventions have been shown to enhance pharmacotherapy outcomes in bipolar disorder. OBJECTIVE: To examine the benefits of 4 disorder-specific psychotherapies in conjunction with pharmacotherapy on time to recovery and the likelihood of remaining well after an episode of bipolar depression. DESIGN: Randomized controlled trial. SETTING: Fifteen clinics affiliated with the Systematic Treatment Enhancement Program for Bipolar Disorder. Patients A total of 293 referred outpatients with bipolar I or II disorder and depression treated with protocol pharmacotherapy were randomly assigned to intensive psychotherapy (n = 163) or collaborative care (n = 130), a brief psychoeducational intervention. INTERVENTIONS: Intensive psychotherapy was given weekly and biweekly for up to 30 sessions in 9 months according to protocols for family-focused therapy, interpersonal and social rhythm therapy, and cognitive behavior therapy. Collaborative care consisted of 3 sessions in 6 weeks. MAIN OUTCOME MEASURES: Outcome assessments were performed by psychiatrists at each pharmacotherapy visit. Primary outcomes included time to recovery and the proportion of patients classified as well during each of 12 study months. RESULTS: All analyses were by intention to treat. Rates of attrition did not differ across the intensive psychotherapy (35.6%) and collaborative care (30.8%) conditions. Patients receiving intensive psychotherapy had significantly higher year-end recovery rates (64.4% vs 51.5%) and shorter times to recovery than patients in collaborative care (hazard ratio, 1.47; 95% confidence interval, 1.08-2.00; P = .01). Patients in intensive psychotherapy were 1.58 times (95% confidence interval, 1.17-2.13) more likely to be clinically well during any study month than those in collaborative care (P = .003). No statistically significant differences were observed in the outcomes of the 3 intensive psychotherapies. CONCLUSIONS: Intensive psychosocial treatment as an adjunct to pharmacotherapy was more beneficial than brief treatment in enhancing stabilization from bipolar depression. Future studies should compare the cost-effectiveness of models of psychotherapy for bipolar disorder. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00012558.

Treatment characteristics and illness burden among European Americans, African Americans, and Latinos in the first 2,000 patients of the systematic treatment enhancement program for bipolar disorder.

OBJECTIVE: Across ethnicity/race, prevalence rates of bipolar disorder are similar. However, African Americans and Latinos may receive less specialty mental health treatment and different medications, and may be less adherent to treatment regimens than European American patients. This study compared illness characteristics, treatment history, and overall functioning in a sample of European American, African American, and Latino patients with bipolar disorder. METHODS: The samples were drawn from the first 2,000 patients enrolled in the Systematic Treatment Enhancement Program for Bipolar Disorder. There were 1,686 European Americans, 65 African Americans, and 77 Latinos. The data were collected upon study entry, with structured interviews, clinicianrated forms, and self report. RESULTS: African Americans had a greater likelihood of psychosis and fewer psychiatric medication prescriptions than did European Americans. Latinos had greater alcohol comorbidity, fewer psychiatric medication prescriptions and specialty treatment visits, and more frequent religious service attendance than did European Americans. Depression and manic episode severity and functional outcomes were similar across groups. CONCLUSIONS: Patients with bipolar disorder who are members of ethnic/racial minority groups continue to receive less intensive specialized mental health treatment than do European American patients. These findings may be related to provider, patient, or provider-patient relationship variables. Despite treatment differences and greater comorbidity and sympomatology, there were no differences among the three groups in overall functioning, suggesting additional outcome measurement is warranted.

Factors associated with stigma among caregivers of patients with bipolar disorder in the STEP-BD study.

OBJECTIVE: Little is known about the factors contributing to mental illness stigma among caregivers of people with bipolar disorder. METHODS: A total of 500 caregivers of patients participating in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study were interviewed in a cross-sectional design on measures of stigma, mood, burden, and coping. Relatives and friends with bipolar disorder were assessed on measures of diagnosis and clinical status, determined by a days-well measure derived from psychiatrist ratings of DSM-IV episode status. Because patients' clinical status varied widely, separate models were run for patients who were euthymic for at least three-fourths of the past year (well group) and for those who met criteria for an affective episode for at least one-fourth of the previous year (unwell group). Stepwise multiple regression was used to identify patient, illness, and caregiver characteristics associated with caregiver stigma. RESULTS: In the unwell group, greater mental illness stigma was associated with bipolar I (versus II) disorder, less social support for the caregiver, fewer caregiver social interactions, and being a caregiver of Hispanic descent. In the well group, greater stigma was associated with being a caregiver who is the adult child of a parent with bipolar disorder, who has a college education, who has fewer social interactions, and who cares for a female bipolar patient. CONCLUSIONS: Mental illness stigma was found to be prevalent among caregivers of persons with bipolar disorder who have active symptoms as well as for caregivers of those who have remitted symptoms. Stigma is typically associated with factors identifying patients as "different" during symptomatic periods. Research is needed to understand how the stigma experienced by caregivers during stable phases of illness differs from the stigma experienced during patients' illness states.

A case study of psychodynamic group psychotherapy for bipolar disorder.

BACKGROUND: This study examines the effectiveness of long-term outpatient psychodynamic group psychotherapy for individuals with bipolar disorder who may have psychiatric comorbidity. METHOD: The Integrative Outpatient Model (IOM) includes psychoeducation regarding illness, illness management, and exploration of dynamic and interpersonal issues. RESULTS: At one-year follow up, group members had significantly less depressive symptomatology and were less likely to be in a mood episode, compared to controls. There were no between-group differences in manic symptoms or global assessments of functioning. For group-treated patients, the number of days well per week improved significantly; there were no significant improvements in the control group. CONCLUSIONS: This pilot study indicates that psychodynamic group psychotherapy is feasible as a component of treatment for bipolar disorder diagnoses. The results suggest benefits on depressive, but not manic symptoms. The 73% retention rate suggests that further study of this treatment is warranted, especially in the cases of patients for whom pharmacotherapy alone is not sufficient.