MEDICATION ADHERENCE AND OUTCOMES IN SCHIZOPHRENIA

精神分裂症的药物依从性和结果

• 批准号: 6528905
• 负责人: Dawn Irene Velligan
• 金额: $ 30.5万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6528905
• 关键词: antipsychotic agents; behavior modification; behavioral /social science research tag; clinical research; cognitive behavior therapy; human subject; human therapy evaluation; mental disorder chemotherapy; outcomes research; psychopharmacology; schizophrenia; therapy compliance

DESCRIPTION (investigator's abstract): It is well established that poor adherence to antipsychotic medication can lead to relapse and re-hospitalization for schizophrenia patients. Prominent among the many reasons for non-adherence to pharmacotherapy are cognitive deficits, which contribute to forgetting to take medication and the failure to establish routines that would promote adherence. In a series of studies, we showed that Cognitive Adaptation Training (CAT) --- a manual-driven set of environmental supports (signs, checklists, electronic devices) designed to bypass specific neurocognitive deficits --- significantly improved symptomatology, adaptive functioning and rates of relapse in schizophrenia patients compared to control conditions. One interpretation of these results is that the environmental supports established specifically to increase adherence to medications were responsible for the better outcomes observed in CAT. We plan to examine this issue in a sample of 90 schizophrenia patients on atypical antipsychotic medications. After obtaining blood levels during hospital stay to determine intra-individual variability in plasma concentration of antipsychotic medication during optimal adherence, patients will be followed prospectively from the time of discharge for three months. This will allow us to examine predictors of poor adherence to atypical antipsychotics in the sample. Next, patients will be randomly assigned for 9 months to one of three treatment groups: (1) Full-CAT, (a comprehensive use of environmental supports to improve multiple areas of adaptive functioning), (2) Pharm-CAT (supports for medication adherence only), (3) Treatment as usual. All patients will be followed for 6 months after CAT treatments have been discontinued. Primary outcome variables will include medication compliance (blood levels), and measures of symptomatology, and adaptive functioning obtained at study entrance and each 3 months. Analyses of covariance, with pretreatment scores used as covariates, will be utilized to examine group differences on the outcome variables at the end of treatment and follow-up. We hypothesize that both Pharm-CAT and Full-CAT will improve adherence, symptomatology and rates of relapse but that only the comprehensive Full-CAT program will improve adaptive functioning. Moreover, we hypothesize that compliance and functioning will return to baseline levels six months after discontinuation of treatment.

描述（研究者的摘要）：众所周知，穷人 坚持服用抗精神病药物可能会导致复发和 精神分裂症患者再次住院。在众多原因中尤为突出 不坚持药物治疗是认知缺陷，这会导致 忘记服药以及未能建立规律的生活习惯 将促进依从性。在一系列研究中，我们表明认知 适应训练（CAT）——一套手动驱动的环境支持 （标志、清单、电子设备）旨在绕过特定 神经认知缺陷——症状、适应性显着改善 与对照组相比，精神分裂症患者的功能和复发率 状况。对这些结果的一种解释是，环境 专门为提高药物依从性而建立的支持 负责在 CAT 中观察到更好的结果。我们计划对此进行研究 90 名服用非典型抗精神病药物的精神分裂症患者样本中存在的问题 药物。在住院期间获取血药浓度后确定 抗精神病药物血浆浓度的个体差异 在最佳依从性期间用药，将对患者进行前瞻性随访 自出院之日起三个月内。这将使我们能够检查 样本中非典型抗精神病药物依从性差的预测因素。下一个， 患者将被随机分配接受三种治疗中的一种，为期 9 个月 组：（1）Full-CAT，（综合利用环境支持来改善 适应性功能的多个领域），（2）Pharm-CAT（支持药物治疗） 仅坚持），（3）照常治疗。所有患者均将接受随访 6 CAT 治疗停止后几个月。主要结果变量 将包括药物依从性（血液水平）以及 在研究开始时获得的症状学和适应性功能以及每 3 几个月。协方差分析，使用预处理评分作为协变量， 将用于检查结果变量的组间差异 治疗结束和随访。我们假设 Pharm-CAT 和 Full-CAT 会改善依从性、症状和复发率，但只有 全面的 Full-CAT 计划将改善适应性功能。此外，我们 假设合规性和功能将恢复到基线水平六 停止治疗几个月后。