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ArticleTrials2025

Blended therapy for adolescents with chronic health conditions to increase fatigue-related self-efficacy (Booster): protocol for a single-case multiple baseline study.

Maartje D Stutvoet, Anouk Vroegindeweij, Jan Houtveen, Raphaële R L van Litsenburg, Elise van de Putte, Remco C Veltkamp, Sanne L Nijhof

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06562335 (Blended Therapy for Youth With a Chronic Health Condition to Increase Fatigue-related Self-efficacy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT06562335 nanot yet recruitingnot on this map

Blended Therapy for Youth With a Chronic Health Condition to Increase Fatigue-related Self-efficacy (Booster): Protocol for a Multiple Baseline Single Case Experimental Study

TypeinterventionalSponsorUMC UtrechtRan2024 to 2025Enrolled20ConditionsFatigue, Chronic IllnessesArmsBooster
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

7 authors.

Maartje D StutvoetDepartment of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands. m.d.stutvoet@umcutrecht.nl.ORCID http://orcid.org/0000-0002-8857-7749
Anouk VroegindeweijDepartment of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
Jan HoutveenDepartment of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
Raphaële R L van LitsenburgPrincess Máxima Centre for Paediatric Oncology, Utrecht, The Netherlands.
Elise van de PutteDepartment of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
Remco C VeltkampDepartment of Information and Computing Sciences, Utrecht University, Utrecht, The Netherlands.
Sanne L NijhofDepartment of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.

Funding

Nederlandse Organisatie voor Wetenschappelijk Onderzoek NWA.1292.19.226
6 · The paper itself

Abstract

backgroundFatigue is a common symptom in adolescents with a chronic health condition. Persistent fatigue and its impairments may be prevented by early intervention with Booster. Booster is a transdiagnostic blended care intervention that aims to increase fatigue-related self-efficacy (FSE). Through experience sampling methodology (ESM) via the Booster smartphone app, Booster helps users gain personalised insight into the relationship between their thoughts, feelings, activities, and fatigue. Based on this insight and shared-decision making, the participant and executive investigator set personal lifestyle goals, such as more exercise and fewer daytime naps. The previous version of Booster, PROfeel, has already been shown effective in treating persistent fatigue in youth. Booster's value as an early intervention has yet to be studied. To better suit this aim and align with user preferences, the new Booster app includes features like goal attainment assistance, daily outcome tracking, and motivating game mechanics (e.g., rewards and a minigame). This protocol describes a study to examine the effect of Booster on FSE and the other study outcomes fatigue, school participation, life satisfaction, and perceived health. The secondary aim is to explore individual differences regarding (moment of) changes in outcomes during the Booster intervention.

methodsIt is a single-centre study with a multiple baseline single-case experimental design (SCED). We aim to include twenty adolescents ages 12 to 18 years with a chronic health condition and fatigue. Booster's effect on outcomes will be measured with a daily survey during Phase A (baseline) and B (intervention). The start of phase B will be randomised across cases. The effect will be assessed with the multiple baseline single-case randomisation test (SCRT) at the group level. Additionally, at the single-case level, we will explore change using permutation distancing tests (PDTs), single-case interrupted time series analysis (ITSA), and change point analyses. Also, we will assess participant characteristics associated with (long-term) improvements. DISCUSSION: Booster uses innovative methods by combining tailored ESM-insight, mHealth and healthcare professional support. Group-level analysis, strengthened by single-case observational analyses, will evaluate the effectiveness of ESM-supported blended care as an early fatigue intervention and identify its potential working mechanisms. It lays the groundwork for implementing ESM tools in clinical practice.

trial registrationClinicalTrials, NCT06562335. Registered on 24 July 2024, https://clinicaltrials.gov/study/NCT06562335 .

Indexed as

Adolescent BehaviorFatigueMobile ApplicationsSelf EfficacyAdolescentChildChronic DiseaseFemaleHumansMaleSmartphoneTime FactorsTreatment OutcomeAdolescentChronic diseaseEarly medical interventionExperience samplingFatigueLifestyleMobile healthSelf efficacySingle-case experimental design

Identifiers

PMID40708017
PMCPMC12291284

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Registered trials

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.