First Episode Program, Psychiatric Department, Federal University of Sao Paulo, Sao Paulo, Brazil.
Clinical Neuroscience Lab, Federal University of Sao Paulo, Sao Paulo, Brazil.
JMIR Res Protoc. 2024 Sep 6;13:e57031. doi: 10.2196/57031.
Schizophrenia is a disorder associated with neurocognitive deficits that adversely affect daily functioning and impose an economic burden. Cognitive rehabilitation interventions, particularly during the early phases of illness, have been shown to improve cognition, functionality, and quality of life. The Feuerstein Instrumental Enrichment (FIE) program, based on the Mediated Learning Experience and the Structural Cognitive Modifiability theory, has been applied in various disorders, but its applicability in schizophrenia has not yet been clarified.
This study aims to investigate the effects of the FIE program on the functionality of patients with first-episode schizophrenia.
In total, 17 patients will be recruited for an open-label intervention consisting of twice-weekly sessions for 10 weeks. The primary outcome measure will be changes in the Goal Achievement Scale score. Maze task performance from the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery will serve as a secondary outcome measure. At the same time, changes in Positive and Negative Syndrome Scale scores and other MATRICS domains will be analyzed as exploratory outcomes. Assessments will be administered before and after the intervention, with a follow-up period of 6 months.
This trial was preregistered in The Brazilian Registry of Clinical Trials (RBR-4gzhy4s). By February 2024, 11 participants were enrolled in the training. Recruitment is expected to be completed by May 2024. Data analysis will be conducted between May and September 2024. The results are expected to be published in January 2025.
This study may establish a protocol for the FIE program that uses mediation techniques for individuals in the early stages of schizophrenia. The results will add to the knowledge about strategies to promote cognitive skills and functional impairment in daily life.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57031.
精神分裂症是一种与神经认知缺陷相关的疾病，这些缺陷会对日常功能产生负面影响，并造成经济负担。认知康复干预措施，特别是在疾病早期阶段，已经被证明可以改善认知、功能和生活质量。 Feuerstein 工具丰富（FIE）计划基于中介学习体验和结构认知可变性理论，已应用于各种疾病，但在精神分裂症中的适用性尚未明确。
本研究旨在调查 FIE 计划对首发精神分裂症患者功能的影响。
总共将招募 17 名患者进行开放标签干预，包括每周两次、持续 10 周的治疗。主要结局指标将是目标实现量表评分的变化。MATRICS 认知治疗和研究评估测试（MATRICS）成套测验中的迷津任务表现将作为次要结局指标。同时，将分析阳性和阴性综合征量表评分和其他 MATRICS 领域的变化作为探索性结局。干预前后将进行评估，并进行 6 个月的随访。
该试验已在巴西临床试验注册处（RBR-4gzhy4s）预先注册。截至 2024 年 2 月，已有 11 名参与者参加了培训。预计 2024 年 5 月完成招募。数据分析将于 2024 年 5 月至 9 月进行。预计结果将于 2025 年 1 月公布。
本研究可能为 FIE 计划制定一个方案，该方案使用中介技术为早期精神分裂症患者提供服务。研究结果将为促进认知技能和日常生活功能障碍的策略提供更多知识。
国际注册报告标识符（IRRID）：DERR1-10.2196/57031。
