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: 10451712
• 负责人: SHAUN M EACK
• 金额: $ 69.05万
• 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/10451712
• 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; Life; Mediator of activation protein; 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; base; blind; cognitive enhancement; cognitive function; cognitive testing; confirmatory clinical trial; confirmatory trial; cost; disability; effective therapy; efficacy evaluation; evidence base; experience; follow-up; functional disability; functional outcomes; improved; 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. 项目概要/摘要 精神分裂症是所有精神疾病中最严重的一种，给患者带来沉重的负担 关于患有该疾病的个人及其家庭成员和社会。进展 药物治疗和心理社会干预显着减少了住院率和 精神病症状，并为受影响的个人提供了更加融入社会的机会 社区成员。尽管取得了这一重大进展，许多精神分裂症患者仍然 因持续的负面症状而明显残疾，包括缺乏动力、社交退缩、情绪化 迟钝和言语贫乏。目前的药物疗法无法治疗这些阴性症状 众所周知，他们对现有的干预措施反应迟钝，使患者和家人几乎没有任何帮助 治疗的选择。最近，人们越来越认识到认知和认知之间的重叠。 精神分裂症的阴性症状和认知矫正的心理社会研究已经开始表明 承诺通过利用计算机和小组练习来增强社交能力来治疗阴性症状 和非社会认知。我们在三个独立的随机试验的事后分析中初步观察到 对照试验表明认知增强疗法（CET）是一种基于证据的认知疗法 治疗精神分裂症的方法可以显着减少广泛的阴性症状范围。更远， 神经认知和社会认知的改善似乎是这些症状减轻的基础，并指出 认知增强是治疗阴性症状最有希望的方法之一 精神分裂症。然而，迄今为止，尚未进行充分设计的认知矫正干预试验。 在有中度至重度和持续阴性症状的患者中进行，以确认这些效果。 回应 RFA-MH-18-707，“非药物干预的验证功效临床试验 对于精神障碍”，该项目建议进行验证性疗效试验，以检验 CET用于治疗具有显着且持续的阴性症状的精神分裂症患者。总共有 75 名病情稳定、具有中度至重度持续阴性症状的精神分裂症门诊患者将被 随机接受 18 个月的 CET 或积极、强化的支持治疗对照。综合数据 持续的阴性症状、社会和非社会认知以及功能结果将在之前收集 进行治疗并每隔 6 个月进行一次频繁的治疗，以 (1) 确认 CET 对于改善持续性症状的功效 阴性症状； (2)确认认知目标参与对减少阴性症状的影响； (3) 检查 CET 对阴性症状和功能的影响的短期持久性。结果 该项目预计将为治疗持续性负面情绪建立有希望的新途径 症状，并显着减轻与此相关的个人和公共健康负担 精神分裂症。