Behavioral Intervention to Reduce Novel Antipsychotic Medication Health Risks

降低新型抗精神病药物健康风险的行为干预

• 批准号: 7161885
• 负责人: Jeffrey A Kelly
• 金额: $ 32.19万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7161885
• 关键词: antipsychotic agents; attention; behavior test; behavior therapy; behavioral /social science research tag; body composition; clinical research; clinical trials; exercise; focus groups; group counseling; health behavior; human subject; human therapy evaluation; interview; longitudinal human study; obesity; patient oriented research; personal log /diary; quality of life; racial /ethnic difference; therapy adverse effect; therapy compliance; weight control; weight loss

DESCRIPTION (provided by applicant): "Novel" or "atypical" antipsychotic medications constitute the current standard of care for the treatment of many serious mental illnesses because they target both positive and negative symptoms and have fewer extrapyramidal side effects than earlier medications. However, there is growing concern that these psychiatric benefits are offset by serious negative medical consequences related to weight gain including obesity-related cardiovascular risk, insulin resistance, diabetes, and diabetic ketoacidosis. The risk/benefit ratio of atypical antipsychotic regimens could be improved if behavioral interventions helped persons with serious mental illness to reduce weight, sustain weight loss, and achieve better fitness. HIV prevention research has shown that cognitive-behavioral small-group interventions-especially when combined with mechanisms that provide peer and structural/environmental risk reduction support-can help persons change even longstanding risk patterns. Following a period of formative ethnographic research related to intervention development, this project will evaluate the effects of a behavior change intervention modeled after approaches shown effective in the HIV prevention field. In a randomized controlled trial design, 20 community group homes providing residence to persons with serious mental illness will be assigned to either an experiemental intervention that seeks to decrease residents' weight and increase exercise, or to a time- matched attention control program. The intervention, based on social-cognitive theoretical principles, will include a 20-session small-group component conducted in each group home focused on diet and exercise. Social leaders identified in each home will be trained to support others' efforts, and environmental change supports will be introduced in the group home settings. At baseline and a 3 post-intervention followup points over 12 months, data will be collected to measure change in: (1) participants' diet and exercise patterns using self-report and observational methods including daily pedometer and food monitoring for one-week periods; (2) clinical health indicators (weight, body mass index, body fat distribution, pulse rate, and blood pressure; (3) laboratory tests measuring blood glucose, cholesterol HDL, LDL, triglicerides, and other indicators; and (4) ancillary domains including psychological well-being, health quality of life, and self- reported antipsychotic medication adherence. We hypothesize that residents in experimental condition group homes will show greater average weight loss, greater reduction in body mass index, and positive effects across other behavioral, clinical, physiological, and ancillary measures than residents in control condition group homes at each followup point. If successful, this research will identify a pratical behavioral intervention approach that may be able to offset significant medical risk factors often experienced by persons with serious mental illness, especially those on novel antipsychotic medications.

描述（由申请人提供）：“新型”或“非典型”抗精神病药物构成了当前治疗许多严重精神疾病的标准，因为它们针对阳性和阴性症状，并且比早期药物具有更少的锥体外系副作用。然而，人们越来越担心这些精神益处会被与体重增加相关的严重负面医疗后果所抵消，包括肥胖相关的心血管风险、胰岛素抵抗、糖尿病和糖尿病酮症酸中毒。如果行为干预能够帮助患有严重精神疾病的人减轻体重、维持体重减轻并获得更好的健康水平，那么非典型抗精神病药物治疗方案的风险/获益比就可以得到改善。艾滋病毒预防研究表明，认知行为小组干预措施——尤其是与提供同伴和结构/环境风险降低支持的机制相结合——可以帮助人们改变甚至长期存在的风险模式。经过一段时间与干预措施开发相关的形成性人种学研究后，该项目将评估以艾滋病毒预防领域有效的方法为模型的行为改变干预措施的效果。在一项随机对照试验设计中，20 个为患有严重精神疾病的人提供住宿的社区团体之家将被分配到一项旨在减轻居民体重和增加运动的实验性干预措施，或一项时间匹配的注意力控制计划。该干预措施基于社会认知理论原则，将包括在每个小组之家进行 20 次小组会议，重点关注饮食和锻炼。每个家庭中确定的社会领袖将接受培训，以支持其他人的努力，并将在集体家庭环境中引入环境变化支持。在基线和 12 个月内的 3 个干预后随访点，将收集数据以衡量以下方面的变化：(1) 使用自我报告和观察方法（包括每日计步器和为期一周的食物监测）参与者的饮食和运动模式; （2）临床健康指标（体重、体重指数、体脂分布、脉搏率和血压）；（3）测量血糖、胆固醇HDL、LDL、甘油三酯等指标的实验室检查；（4）辅助领域包括心理健康、健康生活质量和自我报告的抗精神病药物依从性，我们假设实验条件组家庭中的居民将表现出更大的平均体重减轻、更大的体重指数下降以及其他行为、临床方面的积极影响。 、生理学和如果成功，这项研究将确定一种实用的行为干预方法，该方法可能能够抵消患有严重精神疾病的人，特别是那些服用新型抗精神病药物的人经常经历的重大医疗风险因素。药物。