Behavioral Intervention to Reduce Novel Antipsychotic Medication Health Risks

描述(申请人提供)：“新的”或“非典型的”抗精神病药物构成了目前治疗许多严重精神疾病的护理标准，因为它们既针对阳性症状也针对阴性症状，并且比以前的药物具有更少的锥体外系副作用。然而，越来越多的人担心，这些精神上的好处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。如果行为干预帮助严重精神疾病患者减轻体重、维持减肥并实现更好的健康，非典型抗精神病药物治疗的风险/收益比可能会得到改善。艾滋病毒预防研究表明，认知-行为小群体干预--特别是与提供同行和结构/环境减少风险支持的机制相结合--可以帮助人们改变甚至长期存在的风险模式。在与干预发展相关的一段时期的形成人种学研究之后，该项目将评估行为改变干预的效果，该干预模仿在艾滋病毒预防领域被证明有效的方法。在一项随机对照试验设计中，为严重精神疾病患者提供住所的20个社区团体之家将被分配到寻求减轻居民体重和增加锻炼的体验性干预，或被分配到时间匹配的注意力控制程序中。这项干预基于社会认知理论原则，将包括在每个小组家庭中进行的20次小组活动，重点是饮食和锻炼。在每个家庭中确定的社会领袖将接受培训，以支持他人的努力，并将在团体之家环境中引入环境变化支持。在基线和干预后超过12个月的3个随访点，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的参与者的饮食和运动模式，包括为期一周的每日计步器和食物监测；(2)临床健康指标(体重、体重指数、体脂分布、脉率和血压)；(3)实验室测试，测量血糖、胆固醇、高密度脂蛋白、低密度脂蛋白、甘油三酯和其他指标；以及(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服药依从性。我们假设，在每个随访点，实验条件团体之家的居民将比对照条件团体之家的居民表现出更大的平均体重减轻，更大的体重指数下降，以及在其他行为、临床、生理和辅助措施上的积极影响。如果成功，这项研究将确定一种实际的行为干预方法，可能能够抵消严重精神疾病患者经常经历的重大医疗风险因素，特别是那些服用新型抗精神病药物的人。

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.