Evidence map›Paper›PMID 33648576›Full record

ArticleTrials2021

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

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

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 52% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

I L KleinRadboud 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. Inge-Lot.Klein@radboudumc.nl.ORCID http://orcid.org/0000-0002-4122-6650
K F E van de LooRadboud 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.
T J HoogeboomRadboud university medical center, Radboud Institute for Health Sciences, IQ Healthcare, PO Box 9101, Geert Grooteplein Zuid 10, 6500 HB, Nijmegen, The Netherlands.
M C H JanssenRadboud university medical center, Radboud Institute for Molecular Life Sciences, Radboud Center for Mitochondrial Medicine, Department of Internal Medicine, PO Box 9101, Geert Grooteplein Zuid 10, 6500 HB, Nijmegen, The Netherlands.
J A M SmeitinkRadboud university medical center, Radboud Institute for Molecular Life Sciences, Radboud Center for Mitochondrial Medicine, Department of Pediatrics, PO Box 9101, Geert Grooteplein Zuid 10, 6500 HB, Nijmegen, The Netherlands.
E van der VeerInternational Mito Patients Association, Bergambacht, The Netherlands.
C M VerhaakRadboud 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.
J A E CustersRadboud 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 Nijmegen · NL

Funding

Prinses Beatrix Spierfonds W.OK17-06
6 · The paper itself

Abstract

backgroundMitochondrial 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.

methodsA 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 registrationDutch Trial Register NTR 7675. Registered on 17 December 2018. Identifier https://www.trialregister.nl/trial/7433.

Indexed as

Cognitive Behavioral TherapyMitochondrial DiseasesAdolescentChildFatigueHumansQuality of LifeResearch DesignBlended cognitive behaviour therapyChildren and adolescentsFatigueMitochondrial diseaseSingle case experiment

Identifiers

PMID33648576
PMCPMC7923335
OpenAlexW3135709241

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.