Blended cognitive behaviour therapy for children and adolescents with mitochondrial disease targeting fatigue (PowerMe): study protocol for a multiple baseline single case experiment

• Published in: Current controlled trials in cardiovascular medicine 2021-03, Vol.22 (1), p.177-177, Article 177
• Main Authors: Klein, I L, van de Loo, K F E, Hoogeboom, T J, Janssen, M C H, Smeitink, J A M, van der Veer, E, Verhaak, C M, Custers, J A E
• Format: Article
• Language: English
• Subjects: Adolescent; Age; Behavior modification; Blended cognitive behaviour therapy; Care and treatment; Child; Children and adolescents; Chronic fatigue syndrome; Chronic illnesses; Cognition & reasoning; Cognitive Behavioral Therapy; Cognitive therapy; Complications and side effects; Disease; Energy; Experiments; Fatigue; Fatigue - diagnosis; Fatigue - therapy; Humans; Intervention; Medical research; Metabolism; Mitochondrial disease; Mitochondrial diseases; Mitochondrial Diseases - diagnosis; Mitochondrial Diseases - therapy; Parents & parenting; Patients; Pediatric research; Pediatrics; Quality of Life; Questionnaires; Research Design; Single case experiment; Study Protocol; Teenagers; Testing
• ISSN: 1745-6215; 1745-6215
• 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.