Univ Paul Valéry Montpellier 3, Univ. Montpellier, EPSYLON EA, Montpellier, France.
University Department of Adult Psychiatry, CHU Montpellier, Montpellier, France.
Trials. 2020 Sep 17;21(1):797. doi: 10.1186/s13063-020-04606-6.
Fatigue is a well-known common clinical feature of numerous chronic diseases including various forms of cancer, neurological disorders such as multiple sclerosis, and psychiatric disorders. A significant proportion of people with schizophrenia (30-60%) reportedly experience fatigue, which impacts negatively on participation in various activities, including work, study, leisure, and social pursuits. Causes of fatigue in schizophrenia are poorly understood and there are no established treatments. Several evidence-based interventions for fatigue syndrome including psychoeducation, cognitive behavioral therapy, and graded exercise therapy have been shown to be effective in other medical conditions and could be adapted to address fatigue in schizophrenia patients. As there are no psychosocial or pharmacological interventions with proved efficacy for fatigue in schizophrenia, there is an urgent need for the development of strategies to improve fatigue management in schizophrenia. The aim of this project is to evaluate in a single blind randomized clinical trial the efficacy of a cognitive-behavioral therapy (CBT) intervention compared to treatment as usual (TAU) on fatigue as the main outcome in schizophrenia patients. Clinical symptoms, physical functioning, major cognitive functions, quality of life and functioning, treatment dosage, daily motor activity, biological markers with inflammatory markers are also considered as secondary outcomes.
METHODS/DESIGN: Two hundred patients meeting the inclusion criteria will be randomized to either of the study arms (intervention or TAU). The ENERGY intervention will be delivered according to a standardized treatment manual comprising six modules addressing fatigue and sleep over 14 individual therapy sessions. The treatment encompasses core CBT principles of psycho-education, behavioral activation, behavioral experiments, cognitive restructuring, problem-solving, and relapse prevention. Sessions will follow the traditional CBT structure of agenda setting, review of homework tasks, and introduction of a new concept/technique with collaborative discussions on how to implement such strategies in the participant's day-to-day environment. Our primary endpoint will be the severity of fatigue assessed at baseline and at the 9-month follow-up using the "Multidimensional Fatigue Inventory" (MFI).
The trial will provide the first test of CBT intervention for fatigue for patients with schizophrenia. This study will also test to what extent the treatment can be implemented in everyday practice.
ClinicalTrials.gov NCT04332601 . Registered on 10 April 2020.
疲劳是许多慢性疾病的一种常见临床特征，包括各种形式的癌症、多发性硬化症等神经系统疾病和精神疾病。据报道，相当一部分精神分裂症患者（30-60%）经历疲劳，这对他们参与各种活动（包括工作、学习、休闲和社交活动）产生负面影响。精神分裂症患者疲劳的原因尚不清楚，也没有既定的治疗方法。几项针对疲劳综合征的循证干预措施，包括心理教育、认知行为疗法和分级运动疗法，已被证明在其他医学病症中有效，可适用于治疗精神分裂症患者的疲劳。由于没有针对精神分裂症疲劳的经过验证的有效心理社会或药物干预措施，因此迫切需要制定改善精神分裂症患者疲劳管理的策略。本项目旨在通过单盲随机临床试验评估认知行为疗法（CBT）干预与常规治疗（TAU）相比对精神分裂症患者疲劳（主要结局）的疗效。还将疲劳相关的临床症状、身体机能、主要认知功能、生活质量和功能、治疗剂量、日常运动活动、生物标志物（包括炎症标志物）作为次要结局进行考量。
方法/设计：将符合纳入标准的 200 名患者随机分配到研究组（干预组或 TAU 组）之一。根据包含六个模块的标准化治疗手册提供 ENERGY 干预，该手册涵盖了 14 次个体治疗，涉及疲劳和睡眠。该治疗包括心理教育、行为激活、行为实验、认知重构、解决问题和复发预防等核心 CBT 原则。每个治疗模块包含 2-3 次治疗会议。会议将遵循传统的 CBT 结构，包括设定议程、回顾家庭作业任务以及介绍新概念/技术，并与参与者合作讨论如何将这些策略应用于他们的日常生活环境中。我们的主要终点是使用“多维疲劳清单”（MFI）在基线和 9 个月随访时评估疲劳的严重程度。
该试验将首次测试针对精神分裂症患者疲劳的 CBT 干预。该研究还将测试治疗在多大程度上可以在日常实践中实施。
ClinicalTrials.gov NCT04332601，于 2020 年 4 月 10 日注册。
