Cognitive Enhancement for Persistent Negative Symptoms in Schizophrenia

精神分裂症持续负面症状的认知增强

• 批准号: 10655377
• 负责人: SHAUN M EACK
• 金额: $ 65.25万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10655377
• 关键词: Address; Affect; Affective; Aftercare; Antipsychotic Agents; Behavioral Sciences; Biological; Chronic; Clinical; Clinical Trials; Clinical assessments; Cognition; Cognitive; Cognitive remediation; Communities; Computers; Data; Disabled Persons; Disease; Dopamine Antagonists; Emotional; Employment; Enrollment; Exercise; Family; Family member; Funding; Glutamatergic Agents; Goals; Hospitalization; Impaired cognition; Independent Living; Individual; Intervention; Interview; Investigation; Mediator; Mental disorders; Motivation; National Institute of Mental Health; Neurocognition; Neurocognitive; Outpatients; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Population; Poverty; Psychosocial Assessment and Care; Public Health; Quality of life; Randomized; Randomized, Controlled Trials; Schizophrenia; Societies; Speech; Supportive care; Symptoms; Therapeutic; Withdrawal; blind; clinical trial analysis; cognitive enhancement; cognitive testing; confirmatory clinical trial; confirmatory trial; cost; disability; effective therapy; efficacy evaluation; evidence base; experience; follow-up; functional disability; functional outcomes; improved; information gathering; member; novel; pleasure; psychosocial; psychotic symptoms; reduce symptoms; response; social; social cognition; standard measure; symptom treatment; therapy design; treatment comparison; trial design; virtual

7. PROJECT SUMMARY/ABSTRACT Schizophrenia is one of the most disabling of all psychiatric conditions, and places significant burden on the individuals who experience the disorder, as well as their family members and society. Advances in pharmacotherapy and psychosocial interventions have led to significant reductions in hospitalization and psychotic symptoms, and have provided opportunities for affected individuals to become more integrated members of the community. Despite this significant progress, many individuals with schizophrenia remain markedly disabled by persistent negative symptoms, including lack of motivation, social withdrawal, emotional blunting, and poverty of speech. These negative symptoms are untreated by current pharmacotherapies and are notoriously unresponsive to existing interventions, leaving patients and family members with little to no options for treatment. Recently, there has been growing appreciation of the overlap between cognitive and negative symptoms in schizophrenia, and psychosocial studies of cognitive remediation have begun to show promise in treating negative symptoms by utilizing computer- and group-based exercises to enhance social and non-social cognition. We have preliminarily observed in post-hoc analyses of three separate randomized- controlled trials that Cognitive Enhancement Therapy (CET), an evidence-based cognitive remediation approach for schizophrenia, can result in significant reductions in broad negative symptom domains. Further, neurocognitive and social-cognitive improvement appear to underlie these symptom reductions, and point to the enhancement of cognition as one of the most promising approaches for treating negative symptoms in schizophrenia. To date, however, adequately designed trials of cognitive remediation interventions have yet to be conducted in patients with moderate-to-severe and persistent negative symptoms to confirm these effects. In response to RFA-MH-18-707, "Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders", this project proposes to conduct a confirmatory efficacy trial to examine the efficacy of CET for the treatment of schizophrenia patients with significant and persistent negative symptoms. A total of 75 stabilized schizophrenia outpatients with moderate-to-severe persistent negative symptoms will be randomized to 18 months of CET or an active, enriched supportive therapy control. Comprehensive data on persistent negative symptoms, social and non-social cognition, and functional outcome will be collected prior to treatment and at frequent 6-month intervals to (1) confirm the efficacy of CET for improving persistent negative symptoms; (2) confirm the impact of cognitive target engagement on reduced negative symptoms; and (3) examine the short-term durability of CET effects on negative symptoms and functioning. The results of this project are expected to establish promising new avenues for the treatment of persistent negative symptoms in the condition, and to significantly reduce the personal and public health burden associated with schizophrenia.

7。项目摘要/摘要 精神分裂症是所有精神疾病中最残疾的一种，并承担重大负担 关于经历这种疾病的个人以及他们的家人和社会。进步 药物治疗和社会心理干预措施已导致住院和 精神病症状，并为受影响的个体提供了更加整合的机会 社区成员。尽管取得了重大进展，但许多精神分裂症的人仍然存在 持续的负面症状明显残疾，包括缺乏动力，社交戒断，情感 钝器和言语的贫穷。这些负面症状未经当前的药物治疗和 众所周知，对现有干预措施没有反应，使患者和家人几乎没有到没有 治疗的选择。最近，人们对认知与认知和 精神分裂症的负面症状以及认知补救的社会心理研究已经开始表明 通过利用计算机和基于小组的练习来增强社会的承诺来治疗负面症状 和非社会认知。我们已经在三个单独的随机 - 认知增强疗法（CET）的对照试验，这是一种基于证据的认知修复 精神分裂症的方法可能导致广泛的负面症状结构域大幅减少。更远， 神经认知和社会认知改善似乎是这些症状减轻的基础，并指向 认知的增强是治疗负面症状的最有希望的方法之一 精神分裂症。但是，迄今 可以在中度到重度和持续性负症状的患者中进行确认这些作用。 为了响应RFA-MH-18-707，“非药理学干预措施的验证性临床试验 对于精神障碍”，该项目建议进行确认性效果试验，以检查 CET治疗具有严重和持续性阴性症状的精神分裂症患者。总共 75个稳定的精神分裂症门诊患者，中度至重度持续的负面症状将是 随机分配至18个月的CET或活跃的，富含的支持治疗控制。全面数据 持续的负面症状，社会和非社会认知以及功能结果将在之前收集 进行治疗，并在6个月的时间间隔频繁地进行（1）确认CET提高持久性的功效 负面症状； （2）确认认知目标参与对减少负面症状的影响； （3）检查CET对负面症状和功能的短期耐用性。结果 预计该项目将建立有希望的新途径来治疗持续的负面 症状处于这种状况，并大大减轻与之相关的个人和公共卫生负担 精神分裂症。