1/2-Combined Oxytocin and CBSST for Social Function in People with Schizophrenia

描述(由申请人提供)：相当大比例的精神分裂症患者的特征是社交能力受损，这可能反映出失败主义信念带来的社交厌恶；社交互动动机减弱；和/或社交互动的正常强化价值受损。这些社会功能障碍已被证明与社交技能缺陷有关；识别和记忆情绪面部表情的能力下降，并对他人的情绪状况产生共鸣。不幸的是，药物干预对受损的社会功能的好处有限，而心理社会干预对疾病的这一关键方面只提供了部分好处。开发一种有效的功能结果干预措施仍然是治疗的核心挑战。认知行为社交技能培训(CBSST)利用成功互动提供的纠正性反馈和强化来挑战和减少导致动力不足和干扰社会功能的失败主义表现信念。CBSST已被证明对精神分裂症患者的社会功能影响不大。催产素在调节正常的社会联系行为中起着关键作用；它被认为是通过减少社交焦虑或风险厌恶、增强亲社会接近行为的动机和/或增加对社会线索的突出和处理来加强社会联系的。精神分裂症患者的催产素水平降低，这与识别面部情绪的能力受损和亲社会行为减少有关。在CBSST中加入催产素的假设是：1)通过减少社会风险厌恶和回避来减少失败主义行为信念；2)通过改善近邻的社会行为来增强社会技能的获得；3)通过其对亲社会依恋行为和减少社会不兴趣的影响，促进将所学的社会技能转化为社区实践。 我们将进行一项为期24周的双盲、安慰剂对照、随机临床试验，并进行为期3个月的随访评估。本研究的主要目的是收集关于联合CBSST催产素对精神分裂症患者社会功能的疗效的初步数据。次要目标包括审查拟议干预措施的安全性和可接受性。我们还将研究拟议干预的效果是否通过减少失败主义表现信念、增强信任他人的能力和/或改善面部识别和记忆指标的表现来调节。最后，在一个探索性的框架中，我们将检查拟议的干预措施对症状、神经心理测试成绩和全球临床改善的影响。我们将获得社会功能、变化机制、神经心理和症状评估，以检查治疗效果的有效性、安全性和介导性。这项研究将为催产素CBSST改善精神分裂症患者社会功能的临床应用提供关键的初步数据。

DESCRIPTION (provided by applicant): A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others, which may reflect social aversion secondary to defeatist beliefs; decreased motivation for social interactions; and/or impairment in the normal reinforcement value of social interactions. These impairments in social function have been shown to be associated with social skill deficits; and decreased ability to identify and remember emotional facial expressions and empathize with the emotional status of others. Unfortunately, pharmacological interventions have limited benefits for impaired social function, whereas psychosocial interventions provide only partial benefit for this critical aspect f the illness. The development of an effective intervention for functional outcomes remains a central therapeutic challenge. Cognitive Behavioral Social Skills Training (CBSST) uses corrective feedback and reinforcement provided by successful interactions to challenge and reduce defeatist performance beliefs that contribute to low drive and interfere with social functioning. CBSST has been shown to have modest effects on social function in people with schizophrenia. Oxytocin plays a critical role in the regulation of normal social affiliative behavir; it is hypothesized to enhance social affiliation through the reduction of social anxiety or risk aversion; the enhancement of motivation for prosocial approach behavior; and/or increased modulation of the salience and processing of social cues. People with schizophrenia have decreased oxytocin levels, which are associated with an impaired ability to identify facial emotions and decreased prosocial behaviors. The addition of oxytocin to CBSST is hypothesized to: 1) enhance the reduction of defeatist performance beliefs by reducing social risk aversiveness and avoidance; 2) enhance social skill acquisition through improvement of proximal social behaviors; and 3) facilitate the translation of learned social skills into communit practice through its effects on prosocial attachment behaviors and reduction in social disinterest. We will conduct a 24-week, double-blind, placebo- controlled, randomized clinical trial with a 3-month follow-up evaluation. The primary aim of the study is to collect preliminary data on the efficacy of combined CBSST + oxytocin for social function in schizophrenia. Secondary aims include the examination of the safety and acceptability of the proposed intervention. We will also examine whether the effects of the proposed intervention are mediated by reduced defeatist performance beliefs; increased ability to trust others; and/or improved performance on measures of facial recognition and memory. Finally, in an exploratory framework, we will examine the effects of the proposed intervention on symptoms, neuropsychological test performance, and global clinical improvement. We will obtain social function, mechanism of change, neuropsychological, and symptom assessments to examine the efficacy, safety, and mediation of treatment effects. The study will provide critical preliminary data on the clinical utility of oxytocin + CBSST for the improvement of social function in people with schizophrenia.