Improving Negative Symptoms of Psychosis In Real-World Environments - INSPIRE

说明(申请人提供)：确定减少与精神分裂症相关的阴性症状的治疗方法具有很高的公共卫生意义，因为阴性症状与功能不良和生活质量之间的关系，以及缺乏针对阴性症状的有效治疗。还需要对认知障碍进行治疗，以改善精神分裂症的日常功能。对于阴性症状和认知/功能障碍的药物治疗在很大程度上是失败的，但心理社会治疗是适度有效的。认知行为社会技能训练(CBSST)和补偿性认知训练(CCT)这两种干预措施显示出治疗阴性症状的希望(Granholm等人，2005、2007、2012；Twamley等人，2008、2012)，以及其他症状、认知和功能。由于CBSST和CCT对阴性症状的显著影响，我们的目标是开发一种CBSST-CCT联合干预，专门针对减轻阴性症状，并收集关于其有效性的试点数据。CBSST(格兰霍姆)和CCT(Twamley)都是以群体为基础的手工干预措施，可以在社区环境中提供，以增强培训效果的普遍性。CBSST将认知行为治疗的元素与社会技能培训相结合，这是精神分裂症的两种循证治疗方法。CCT使用补偿性策略培训和习惯学习来改善认知和日常功能。这两种干预措施对阴性症状都有显著但中等的效果(例如，随访时效果为0.4)。拟议的项目将捆绑和改进CBSST-CCT联合干预措施，以加强其对精神分裂症阴性症状的影响，并将在一项试点随机对照试验中测试这种联合干预措施，将CBSST-CCT与目标聚焦的支持性接触(SC)对照组进行比较。我们建议将具有持续性阴性症状的精神分裂症患者随机分配到两种治疗方法之一治疗9个月，并在治疗后随访3个月。该项目的主要目标是获得关于这一新干预措施的可行性和效果大小的数据，以便计划CBSST-CCT的更大规模的试验。主要结果是阴性症状严重程度，次要结果包括认知表现和日常功能。我们还将研究在CBSST-CCT中调节消极症状严重性降低的机制，包括失败主义信念、认知和社交技能，以及认知和社交任务中的瞳孔反应(目标导向努力分配的生物标记物)。

DESCRIPTION (provided by applicant): Identifying treatments to reduce the negative symptoms associated with schizophrenia is of high public health significance, due to the relationship between negative symptoms and poor functioning and quality of life, and the lack of effective treatments for negative symptoms. There is also a need for treatments of cognitive impairment to improve daily functioning in schizophrenia. Pharmacologic treatments for negative symptoms and cognitive/functional impairment have largely failed, but psychosocial treatments have been moderately effective. Two interventions, Cognitive Behavioral Social Skills Training (CBSST) and Compensatory Cognitive Training (CCT), show promise for treating negative symptoms (Granholm et al., 2005, 2007, 2012; Twamley et al., 2008, 2012), along with other symptoms, cognition, and functioning. Because of the significant effects of both CBSST and CCT on negative symptoms, we aim to develop a combined CBSST-CCT intervention specifically targeted toward negative symptom reduction, and to gather pilot data regarding its efficacy. CBSST (Granholm) and CCT (Twamley) are both manualized, group-based interventions that can be delivered in community settings to enhance generalization of training effects. CBSST combines elements of Cognitive Behavioral Therapy with Social Skills Training, two of the evidence-based treatments for schizophrenia. CCT uses compensatory strategy training and habit learning to improve cognition and everyday functioning. Both interventions have significant but moderate effects on negative symptoms (e.g., .4 at follow-up). The proposed project will bundle and refine a combined CBSST-CCT intervention to strengthen their impact on negative symptoms in schizophrenia and will test this combined intervention in a pilot randomized controlled trial comparing CBSST-CCT with a goal-focused supportive contact (SC) control group. We propose to randomly assign 64 participants with schizophrenia with persistent negative symptoms to one of the two treatments for 9 months, and follow them for 3 months after treatment. The primary goal of this project is to obtain feasibility and effect size data regarding this new intervention in order to plan a larger trial of CBSST-CCT. The primary outcome is negative symptom severity, and secondary outcomes include cognitive performance and everyday functioning. We will also examine mechanisms that mediate reduction in negative symptom severity in CBSST- CCT, including defeatist beliefs, cognitive and social skills, and pupillary responses during cognitive and social tasks (a biomarker of goal-directed effort allocation).