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

描述（由申请人提供）：很大比例的精神分裂症患者的特征是与他人交往的能力受损，这可能反映了继发于失败主义信仰的社会厌恶；社交动机下降；和/或社会互动的正常强化值受损。这些社会功能障碍已被证明与社会技能缺陷有关；识别和记忆情绪面部表情的能力下降以及对他人情绪状态的同情能力下降。不幸的是，药物干预对受损的社会功能的益处有限，而心理社会干预对该疾病的这一关键方面仅提供部分益处。对功能结果进行有效干预的发展仍然是治疗的核心挑战。认知行为社交技能训练（CBSST）利用成功互动提供的纠正反馈和强化来挑战和减少导致低动力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有适度的影响。催产素在正常社会依附行为的调节中起关键作用；假设通过减少社交焦虑或风险厌恶来增强社会联系；亲社会接近行为动机的增强；和/或增加了对社会线索的显著性和处理的调节。精神分裂症患者的催产素水平下降，这与识别面部情绪的能力受损和亲社会行为减少有关。假设在CBSST中添加催产素可以：1)通过降低社会风险厌恶和回避来增强失败主义绩效信念的减少；2)通过近端社会行为的改善促进社会技能习得；3)通过对亲社会依恋行为和减少社会不感兴趣的影响，促进学习到的社会技能转化为社区实践。

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.