Treatment Development Targeting Severe and Persistent Negative Symptoms

针对严重和持续的阴性症状的治疗开发

• 批准号: 8091616
• 负责人: Dawn Irene Velligan
• 金额: $ 20.05万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-01 至 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8091616
• 关键词: Adaptive Behaviors; Address; Adverse effects; Affect; Behavior; Behavioral; Behavioral Symptoms; Characteristics; Clinical Trials; Clinical Trials Design; Cognitive; Cognitive Therapy; Consensus; Cues; Development; Emotional; Evidence based practice; Evidence based treatment; Health Services Research; Home environment; Individual; Intervention; Intervention Studies; Length; Manuals; Measures; Mental Depression; Mental Health; Modeling; Motivation; National Institute of Mental Health; Outcome; Paranoia; Participant; Patients; Pharmaceutical Preparations; Poverty; Preparation; Procedures; Process; Psychological reinforcement; Quality of life; Randomized; Recommendation; Recruitment Activity; Research Project Grants; Sampling; Schizophrenia; Screening procedure; Social Behavior; Specific qualifier value; Specificity; Speech; Symptoms; Techniques; Testing; Therapeutic; Thinking; Time; Training; Visit; Work; active control; base; clinically significant; cohort; design; effective therapy; efficacy trial; functional outcomes; improved; in vivo; information gathering; interest; meetings; novel; pleasure; primary outcome; programs; prospective; psychosocial; randomized trial; remediation; response; skills; skills training; social; therapy development; treatment as usual; treatment effect

DESCRIPTION (provided by applicant): Individuals with schizophrenia who have persistent and clinically significant negative symptoms (PNS) including, restricted affect, diminished emotional range, poverty of speech, decreased motivation and interests, diminished sense of purpose and diminished social drive typically have the poorest functional outcomes and quality of life. The NIMH-MATRICS Consensus Statement on Negative Symptoms indicated that these symptoms were a distinct therapeutic indication representing an unmet therapeutic need for large numbers of individuals with schizophrenia. In addition, the group suggested design features necessary to prove efficacy for PNS. While aspects of negative symptoms may be lessened with existing evidence-based practices, no model addresses the entire constellation of PNS. Based upon decades of work developing and employing evidence-based treatments for schizophrenia, we have developed a novel psychosocial treatment called the MOtiVation and Engagement (MOVE) Program specifically to target multiple domains of severe and persistent negative symptoms and their functional consequences. MOVE is a home based, manual-driven, multi-modal treatment that employs a number of cognitive and behavioral principles to address the broad range of factors contributing to a PNS presentation. The purpose of this study is to examine the feasibility of delivering this intervention while implementing the stringent sample selection and assessment procedures required to clearly demonstrate efficacy for PNS. We will further refine the treatment manual and test a measure to assess ongoing treatment fidelity, train a group of mental health clinicians to conduct MOVE, and examine the feasibility of recruiting and retaining PNS patients in a 9 month trial in which prospective evidence of persistent negative symptoms is required prior to randomization. We will randomize 60 individuals to either MOVE or treatment as usual and examine outcomes for global negative symptoms as well as specific symptom domains. PUBLIC HEALTH RELEVANCE: There are no currently available treatments for persistent negative symptoms in schizophrenia. The MOtiVation and Engagement (MOVE) Program is a novel psychosocial treatment developed specifically for negative symptoms which uses environmental cues, emotional processing training, reinforcement, and skills training to help people initiate and succeed at adaptive and social behaviors. The purpose of this study is to fine-tune the intervention and study procedures in preparation for a larger scale clinical trial. We will conduct a small scale study to examine the efficacy of MOVE compared to treatment as usual on negative symptoms in 60 individuals meeting criteria for persistent negative symptoms.

描述（由申请人提供）：具有持续性和临床显著阴性症状（PNS）的精神分裂症患者，包括情感受限、情感范围缩小、言语贫乏、动机和兴趣降低、目的感减弱和社会驱动力减弱，通常具有最差的功能结局和生活质量。NIMH-MATRICS阴性症状共识声明表明，这些症状是一种独特的治疗适应症，代表了大量精神分裂症患者未满足的治疗需求。此外，研究小组还提出了证明PNS有效性所需的设计特征。虽然阴性症状的方面可能会减少与现有的循证实践，没有模型解决整个星座的PNS。基于数十年来开发和采用循证治疗精神分裂症的工作，我们开发了一种名为动机和参与（MOVE）计划的新型心理社会治疗方法，专门针对严重和持续性阴性症状及其功能后果的多个领域。MOVE是一种以家庭为基础，手动驱动，多模式的治疗，采用了许多认知和行为原则，以解决广泛的因素，有助于PNS介绍。本研究的目的是检查提供这种干预措施的可行性，同时实施严格的样本选择和评估程序，以明确证明PNS的疗效。我们将进一步完善治疗手册，并测试一项评估持续治疗保真度的措施，培训一组心理健康临床医生进行MOVE，并检查在9个月的试验中招募和保留PNS患者的可行性，其中在随机化之前需要持续阴性症状的前瞻性证据。我们将60名患者随机分为MOVE组或常规治疗组，并检查总体阴性症状和特定症状领域的结局。 公共卫生相关性：目前尚无治疗精神分裂症持续阴性症状的有效方法。动机和参与（MOVE）计划是一种专门针对阴性症状开发的新型心理社会治疗方法，它使用环境线索，情绪处理训练，强化和技能训练来帮助人们开始并成功地适应和社会行为。本研究的目的是微调干预和研究程序，为更大规模的临床试验做准备。我们将进行一项小规模研究，以检查MOVE与常规治疗相比对60名符合持续阴性症状标准的个体的阴性症状的疗效。