Treatment Development Targeting Severe and Persistent Negative Symptoms

描述(申请人提供)：精神分裂症患者具有持续性和临床显著的负面症状(PN)，包括情感受限、情绪范围缩小、言语贫乏、动机和兴趣减弱、使命感减弱和社会动力减弱，通常具有最差的功能结果和生活质量。NIMH-Matrics关于阴性症状的共识声明表明，这些症状是一个明显的治疗适应症，代表着大量精神分裂症患者的治疗需求尚未得到满足。此外，该小组还提出了证明PNS疗效所需的设计特征。虽然负面症状的方面可能会通过现有的循证做法得到缓解，但没有一个模型可以解决整个PNS星座。基于几十年来开发和使用基于证据的精神分裂症治疗方法的工作，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，专门针对严重和持续的阴性症状及其功能后果的多个领域。Move是一种基于家庭的、手动驱动的多模式治疗，采用了许多认知和行为原则来解决导致PNS演示的广泛因素。这项研究的目的是研究在实施严格的样本选择和评估程序的同时提供这一干预措施的可行性，以明确证明PNS的有效性。我们将进一步完善治疗手册，测试评估正在进行的治疗保真度的措施，培训一组精神健康临床医生进行MOVE，并在9个月的试验中研究招募和保留PNS患者的可行性，在随机之前需要持续阴性症状的预期证据。我们将随机选择60名患者，要么照常搬家，要么照常接受治疗，并检查全球阴性症状以及特定症状领域的结果。 与公共卫生相关：目前还没有针对精神分裂症持续阴性症状的治疗方法。动机与参与(Move)计划是一种专门针对负面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在适应和社会行为方面开始并取得成功。这项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。我们将在60名符合持续阴性症状标准的患者中进行一项小规模研究，以检验MOVE与常规治疗对阴性症状的疗效。

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.