Radboud university medical center, Radboud Institute for Health Sciences, Radboud Center for Mitochondrial Medicine, Department of Medical Psychology, PO Box 9101, Geert Grooteplein Zuid 10, 6500 HB, Nijmegen, The Netherlands.
Radboud university medical center, Radboud Institute for Health Sciences, IQ Healthcare, PO Box 9101, Geert Grooteplein Zuid 10, 6500 HB, Nijmegen, The Netherlands.
Trials. 2021 Mar 1;22(1):177. doi: 10.1186/s13063-021-05126-7.
Mitochondrial disease is a rare, hereditary disease with a heterogeneous clinical presentation. However, fatigue is a common and burdensome complaint in children and adolescents with mitochondrial disease. No psychological intervention targeting fatigue exists for paediatric patients with a mitochondrial disease. We designed the PowerMe intervention, a blended cognitive behaviour therapy targeting fatigue in children and adolescents with mitochondrial disease. The aim of the intervention is to reduce perceived fatigue by targeting fatigue-related cognitions and behaviours.
A multiple baseline single case experiment will be conducted in five children (8-12 years old) and 5 adolescents (12-18 years old) with mitochondrial disease and severe fatigue. Patients will be included in the study for 33 weeks, answering weekly questions about the fatigue. Patients will be randomly assigned a baseline period of 5 to 9 weeks before starting the PowerMe intervention. The intervention consists of face-to-face and online sessions with a therapist and a website with information and assignments. The treatment will be tailored to the individual. Each patient will work on their personalized treatment plan focusing on personally relevant goals. The primary outcome is perceived fatigue. Secondary outcomes are quality of life, school presence and physical functioning.
The results of the PowerMe study will provide information on the efficacy of a blended cognitive behaviour therapy on reducing perceived fatigue and its impact on daily life in children and adolescents with mitochondrial disease. Strengths and limitations of the study design are discussed.
Dutch Trial Register NTR 7675. Registered on 17 December 2018. Identifier https://www.trialregister.nl/trial/7433.
线粒体疾病是一种罕见的遗传性疾病，具有异质性的临床表现。然而，疲劳是儿童和青少年线粒体疾病患者常见且负担沉重的主诉。目前针对儿科线粒体疾病患者的疲劳，尚无心理干预措施。我们设计了 PowerMe 干预措施，这是一种针对线粒体疾病儿童和青少年疲劳的混合认知行为疗法。干预的目的是通过针对与疲劳相关的认知和行为来减轻感知到的疲劳。
将对 5 名患有线粒体疾病和严重疲劳的儿童（8-12 岁）和 5 名青少年（12-18 岁）进行多项基线单病例实验。患者将入组研究 33 周，每周回答有关疲劳的问题。患者将在开始 PowerMe 干预之前随机分配 5 至 9 周的基线期。干预包括与治疗师进行面对面和在线会议，以及一个带有信息和作业的网站。治疗将针对个人进行定制。每个患者将专注于个性化的治疗计划，重点是个人相关的目标。主要结局是感知疲劳。次要结局是生活质量、在校存在和身体功能。
PowerMe 研究的结果将提供关于混合认知行为疗法在减轻儿童和青少年线粒体疾病患者感知疲劳及其对日常生活影响的疗效的信息。讨论了研究设计的优势和局限性。
荷兰试验注册 NTR 7675。于 2018 年 12 月 17 日注册。标识符 https://www.trialregister.nl/trial/7433。
