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Published in: Trials 1/2021

Open Access 01-12-2021 | Fatigue | Study protocol

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

Authors: I. L. Klein, K. F. E. van de Loo, T. J. Hoogeboom, M. C. H. Janssen, J. A. M. Smeitink, E. van der Veer, C. M. Verhaak, J. A. E. Custers

Published in: Trials | Issue 1/2021

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Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

Dutch Trial Register NTR 7675. Registered on 17 December 2018. Identifier https://​www.​trialregister.​nl/​trial/​7433
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Metadata
Title
Blended cognitive behaviour therapy for children and adolescents with mitochondrial disease targeting fatigue (PowerMe): study protocol for a multiple baseline single case experiment
Authors
I. L. Klein
K. F. E. van de Loo
T. J. Hoogeboom
M. C. H. Janssen
J. A. M. Smeitink
E. van der Veer
C. M. Verhaak
J. A. E. Custers
Publication date
01-12-2021
Publisher
BioMed Central
Keyword
Fatigue
Published in
Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-021-05126-7

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