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

2/2 联合催产素和 CBSST 对精神分裂症患者社会功能的影响

• 批准号: 8493856
• 负责人: ERIC L GRANHOLM
• 金额: $ 17.4万
• 依托单位: VETERANS MEDICAL RESEARCH FDN/SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-20 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8493856
• 关键词: Acceleration; Address; Adverse effects; Anxiety; Behavior; Behavioral; Belief; Clinical; Clinical Trials; Cognitive; Community Practice; Computers; Cues; Data; Data Analyses; Development; Distal; Double-Blind Method; Emotional; Emotions; Evaluation; Exposure to; Eye; Face; Facial Expression; Feedback; Health Status; Hormones; Impairment; Incidence; Intervention; Lead; Learning; Maryland; Measures; Mediating; Mediation; Minority Groups; Motivation; Neuropsychological Tests; Outcome; Oxytocin; Participant; Performance; Placebo Control; Placebos; Play; Principal Investigator; Procedures; Process; Psychological reinforcement; Quality Control; Randomized Clinical Trials; Recruitment Activity; Regulation; Reporting; Research Design; Resources; Risk; Role; Safety; Sampling; Schizophrenia; Secondary to; Site; Social Behavior; Social Functioning; Social Interaction; Supervision; Symptoms; Therapeutic; TimeLine; Training; Translations; Trust; affiliative behavior; approach behavior; base; data management; depressive symptoms; design; effective intervention; effective therapy; follow-up; functional outcomes; improved; memory recognition; neuropsychological; patient population; psychosocial; public health relevance; quality assurance; skill acquisition; skills training; social; social skills; treatment effect

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.

描述（由申请人提供）：很大一部分精神分裂症患者的特征是与他人进行社会交往的能力受损，这可能反映了继发于失败主义信念的社会厌恶;社会交往的动机降低;和/或社会交往的正常强化值受损。这些社会功能的损害已被证明与社会技能缺陷有关;识别和记忆情绪面部表情以及同情他人情绪状态的能力下降。不幸的是，药物干预对受损的社会功能的益处有限，而心理社会干预仅对疾病的这一关键方面提供部分益处。开发一种有效的功能干预措施仍然是一个中心的治疗挑战。认知行为社会技能训练（CBSST）使用成功的互动提供的纠正反馈和强化来挑战和减少导致低驱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。催产素在正常的社会关系行为的调节中起着关键作用;它被假设通过减少社会焦虑或风险规避来增强社会关系;增强亲社会行为的动机;和/或增加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。CBSST中添加催产素的假设是：1）通过减少社会风险厌恶和回避来增强失败主义表现信念的减少; 2）通过改善近端社会行为来增强社会技能的获得;以及3）通过其对亲社会依恋行为的影响和减少社会不感兴趣来促进学习的社会技能转化为社区实践。 我们将进行一项为期24周、双盲、安慰剂对照、随机临床试验，并进行3个月的随访评估。本研究的主要目的是收集CBSST +催产素联合治疗对精神分裂症患者社会功能疗效的初步数据。次要目的包括检查拟议干预措施的安全性和可接受性。我们还将研究拟议的干预措施的影响是否通过减少失败主义表现信念来介导;增加信任他人的能力;和/或改善面部识别和记忆措施的表现。最后，在一个探索性的框架中，我们将研究所提出的干预措施对症状，神经心理测试表现和全球临床改善的影响。我们将获得社会功能，变化机制，神经心理学和症状评估，以检查疗效，安全性和治疗效果的中介作用。该研究将提供关于催产素+ CBSST改善精神分裂症患者社会功能的临床效用的关键初步数据。