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This chapter describes the development of the study designed to assess the effectiveness of antipsychotic drugs for persons with chronic schizophrenia. The protocol was developed by a team of academic investigators through an inclusive, iterative, and systematic process. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) program was designed to address a discrepancy between research demonstrating the efficacy of antipsychotic drugs and disappointing findings regarding their effectiveness and the ostensible superiority of second-generation antipsychotic (SGA) medications relative to first-generation antipsychotic drugs (FGA) medications. Some of the key study design decisions made by the Schizophrenia Protocol Development Committee, with input from various stakeholder groups, and their rationales are reviewed in this chapter. The study design was that of a practical clinical trial intended to evaluate the effectiveness of treatments in everyday settings to generate results intended to inform clinicians, administrators, policy makers, and patients.
This study investigates the associations between perceived stigma, depressive symptoms and coping among caregivers of people with bipolar disorder. Caregivers of 500 people with DSM–IV bipolar disorder responded to measures of these constructs at study entry Patients' clinical and functional status were evaluated within 30 days of the caregiver assessment. Perceived stigma was positively associated with caregiver depressive symptoms, controlling for patient status and socio-demographic factors. Social support and avoidance coping accounted for 63% of the relationship between caregiver stigma and depression. Results suggest that caregivers' perceptions of stigma may negatively affect their mental health by reducing their coping effectiveness.
Family members of patients with schizophrenia frequently report burdens associated with caring for their relatives.
We evaluate the impact of illness beliefs on the burden reported by family care-givers of people with bipolar illness.
The multivariate relationships between patient symptomatology and family illness beliefs and report of burden were examined at baseline among care-givers of 266 patients with Research Diagnostic Criteria-diagnosed bipolar illness who were subsequently followed for 15 months.
At baseline, 93% of care-givers reported moderate or greater distress in at least one burden domain. As a group, care-giver illness beliefs (illness awareness, perception of patient and family control) explained an additional 18–28% of variance in burden experienced beyond the effects of the patients clinical state and history.
Care-givers of patients with bipolar illness report widespread burden that is influenced by beliefs about the illness.
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