Granholm Eric, Holden Jason L, Sommerfeld David, Rufener Christine, Perivoliotis Dimitri, Mueser Kim, Aarons Gregory A
Veterans Affairs San Diego Healthcare System (116B), 3350 La Jolla Village Drive, San Diego, CA, 92161, USA.
Department of Psychiatry, University of California, San Diego, CA, USA.
Trials. 2015 Sep 30;16:438. doi: 10.1186/s13063-015-0967-8.
Schizophrenia leads to profound disability in everyday functioning (e.g., difficulty finding and maintaining employment, housing, and personal relationships). Medications can effectively reduce positive symptoms (e.g., hallucinations and delusions), but they do not meaningfully improve daily life functioning. Psychosocial evidence-based practices (EBPs) improve functioning, but these EBPs are not available to most people with schizophrenia. The field must close the research and service delivery gap by adapting EBPs for schizophrenia to facilitate widespread implementation in community settings. Our hybrid effectiveness and implementation study represents an initiative to bridge this divide. In this study we will test whether an existing EBP (i.e., Cognitive Behavioral Social Skills Training (CBSST)) modified to work in practice settings (i.e., Assertive Community Treatment (ACT) teams) commonly available to persons with schizophrenia results in better consumer outcomes. We will also identify key factors relevant to developing future CBSST implementation strategies.
METHODS/DESIGN: For the effectiveness study component, persons with schizophrenia will be recruited from existing publicly funded ACT teams operating in community settings. Participants will be randomized to one of the 2 treatments (ACT alone or ACT + Adapted CBSST) and followed longitudinally for 18 months with assessments every 18 weeks after baseline (5 in total). The primary outcome domain is psychosocial functioning (e.g., everyday living skills and activities related to employment, education, and housing) as measured by self-report, testing, and observation. Additional outcome domains of interest include mediators of change in functioning, symptoms, and quality of services. Primary analyses will be conducted using linear mixed-effects models for continuous data. The implementation study component consists of a structured, mixed qualitative-quantitative methodology (i.e., Concept Mapping) to characterize and assess the implementation experience from multiple stakeholder perspectives in order to inform future implementation initiatives.
Adapting CBSST to fit into the ACT service delivery context found throughout the United States creates an opportunity to substantially increase the number of persons with schizophrenia who could have access to and benefit from EBPs. As part of the implementation learning process training materials and treatment workbooks have been revised to promote easier use of CBSST in the context of brief community-based ACT visits.
ClinicalTrials.gov NCT02254733 . Date of registration: 25 April 2014.
精神分裂症会导致日常功能严重受损（例如，在寻找和维持就业、住房及人际关系方面存在困难）。药物能够有效减轻阳性症状（如幻觉和妄想），但无法显著改善日常生活功能。基于证据的心理社会干预措施（EBPs）可改善功能，但大多数精神分裂症患者无法获得这些措施。该领域必须通过调整针对精神分裂症的EBPs，以促进其在社区环境中的广泛实施，来弥合研究与服务提供之间的差距。我们的混合有效性和实施研究是弥合这一差距的一项举措。在本研究中，我们将测试一种现有的EBP（即认知行为社交技能训练（CBSST）），经修改后在精神分裂症患者常见的实际环境（即积极社区治疗（ACT）团队）中实施，是否能带来更好的患者结局。我们还将确定与制定未来CBSST实施策略相关的关键因素。
方法/设计：对于有效性研究部分，将从社区环境中现有的由公共资金资助的ACT团队招募精神分裂症患者。参与者将被随机分配到两种治疗方法之一（单独的ACT或ACT + 改编后的CBSST），并在基线后每18周进行一次评估，纵向随访18个月（共5次）。主要结局领域是心理社会功能（例如，通过自我报告、测试和观察来衡量的与就业、教育和住房相关的日常生活技能和活动）。其他感兴趣的结局领域包括功能变化、症状和服务质量的调节因素。对于连续数据，将使用线性混合效应模型进行主要分析。实施研究部分包括一种结构化的、定性与定量相结合的方法（即概念映射），以从多个利益相关者的角度描述和评估实施经验，为未来的实施举措提供信息。
使CBSST适应美国各地普遍存在的ACT服务提供环境，为大幅增加能够获得基于证据的干预措施并从中受益的精神分裂症患者数量创造了机会。作为实施学习过程的一部分，培训材料和治疗手册已进行修订，以促进在基于社区的简短ACT访视背景下更轻松地使用CBSST。
ClinicalTrials.gov NCT02254733。注册日期：2014年4月25日。
