Treatment Development Targeting Severe and Persistent Negative Symptoms

描述（由申请人提供）：具有持续和临床显著阴性症状（PNS）的精神分裂症患者，包括情感受限、情绪范围缩小、言语贫乏、动机和兴趣下降、目标感减弱和社会驱动力减弱，通常具有最差的功能结果和生活质量。nimh - matrix关于阴性症状的共识声明表明，这些症状是一种独特的治疗指征，代表了大量精神分裂症患者未得到满足的治疗需求。此外，该小组还提出了证明PNS有效性所需的设计特征。虽然现有的循证实践可以减轻阴性症状的某些方面，但没有任何模型可以解决PNS的全部问题。基于数十年来对精神分裂症的循证治疗的发展和应用，我们开发了一种新的心理社会治疗方法，称为动机和参与（MOVE）计划，专门针对多个领域的严重和持续的负面症状及其功能后果。MOVE是一种以家庭为基础、手动驱动的多模式治疗，采用一系列认知和行为原则来解决导致PNS表现的广泛因素。本研究的目的是检验提供这种干预的可行性，同时实施严格的样本选择和评估程序，以明确证明对PNS的有效性。我们将进一步完善治疗手册，测试一种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，并在一项为期9个月的试验中检查招募和保留PNS患者的可行性，该试验在随机化之前需要持续阴性症状的前瞻性证据。我们将随机选取60名患者，将其分为MOVE组和常规组，并检查总体阴性症状和特定症状域的结果。

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.