TY - JOUR
T1 - Identifying disrupted biological factors and patient-tailored interventions for chronic fatigue in adolescents and young adults with Q-Fever Fatigue Syndrome, Chronic Fatigue Syndrome and Juvenile Idiopathic Arthritis (QFS-study)
T2 - study protocol for a randomized controlled trial with single-subject experimental case series design
AU - Vroegindeweij, Anouk
AU - Swart, Joost F.
AU - Houtveen, Jan
AU - Eijkelkamp, Niels
AU - van de Putte, Elise M.
AU - Wulffraat, Nico M.
AU - Nijhof, Sanne L.
N1 - Funding Information:
The QFS-study is granted by the Netherlands Organization for Health Research and Development (ID ZonMW 50-53000-98-566), and received additional funding through crowdfunding. ZonMw and crowdfunding had no role in the study design or data collection, analysis, and interpretation.
Funding Information:
The authors acknowledge all crowdfunding contributors, as well as Q-support, C-support, and Q-uestion for informing potential participants of the present study. The authors acknowledge the ECCF for post-trial care.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/8/19
Y1 - 2022/8/19
N2 - Background: Chronic fatigue with a debilitating effect on daily life is a frequently reported symptom among adolescents and young adults with a history of Q-fever infection (QFS). Persisting fatigue after infection may have a biological origin with psychological and social factors contributing to the disease phenotype. This is consistent with the biopsychosocial framework, which considers fatigue to be the result of a complex interaction between biological, psychological, and social factors. In line, similar manifestations of chronic fatigue are observed in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and juvenile idiopathic arthritis (JIA). Cognitive behavioral therapy is often recommended as treatment for chronic fatigue, considering its effectiveness on the group level. However, not everybody benefits on the individual level. More treatment success at the individual level might be achieved with patient-tailored treatments that incorporate the biopsychosocial framework. Methods: In addition to biological assessments of blood, stool, saliva, and hair, the QFS-study consists of a randomized controlled trial (RCT) in which a single-subject experimental case series (N=1) design will be implemented using Experience Sampling Methodology in fatigued adolescents and young adults with QFS, CFS/ME, and JIA (aged 12–29). With the RCT design, the effectiveness of patient-tailored PROfeel lifestyle advices will be compared against generic dietary advices in reducing fatigue severity at the group level. Pre-post analyses will be conducted to determine relevance of intervention order. By means of the N=1 design, effectiveness of both advices will be measured at the individual level. Discussion: The QFS-study is a comprehensive study exploring disrupted biological factors and patient-tailored lifestyle advices as intervention in adolescent and young adults with QFS and similar manifestations of chronic fatigue. Practical or operational issues are expected during the study, but can be overcome through innovative study design, statistical approaches, and recruitment strategies. Ultimately, the study aims to contribute to biological research and (personalized) treatment in QFS and similar manifestations of chronic fatigue. Trial registration: Trial NL8789. Registered July 21, 2020.
AB - Background: Chronic fatigue with a debilitating effect on daily life is a frequently reported symptom among adolescents and young adults with a history of Q-fever infection (QFS). Persisting fatigue after infection may have a biological origin with psychological and social factors contributing to the disease phenotype. This is consistent with the biopsychosocial framework, which considers fatigue to be the result of a complex interaction between biological, psychological, and social factors. In line, similar manifestations of chronic fatigue are observed in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and juvenile idiopathic arthritis (JIA). Cognitive behavioral therapy is often recommended as treatment for chronic fatigue, considering its effectiveness on the group level. However, not everybody benefits on the individual level. More treatment success at the individual level might be achieved with patient-tailored treatments that incorporate the biopsychosocial framework. Methods: In addition to biological assessments of blood, stool, saliva, and hair, the QFS-study consists of a randomized controlled trial (RCT) in which a single-subject experimental case series (N=1) design will be implemented using Experience Sampling Methodology in fatigued adolescents and young adults with QFS, CFS/ME, and JIA (aged 12–29). With the RCT design, the effectiveness of patient-tailored PROfeel lifestyle advices will be compared against generic dietary advices in reducing fatigue severity at the group level. Pre-post analyses will be conducted to determine relevance of intervention order. By means of the N=1 design, effectiveness of both advices will be measured at the individual level. Discussion: The QFS-study is a comprehensive study exploring disrupted biological factors and patient-tailored lifestyle advices as intervention in adolescent and young adults with QFS and similar manifestations of chronic fatigue. Practical or operational issues are expected during the study, but can be overcome through innovative study design, statistical approaches, and recruitment strategies. Ultimately, the study aims to contribute to biological research and (personalized) treatment in QFS and similar manifestations of chronic fatigue. Trial registration: Trial NL8789. Registered July 21, 2020.
KW - Chronic fatigue syndrome
KW - Diet
KW - Experience sampling methodology
KW - Fatigue
KW - Juvenile idiopathic arthritis
KW - Lifestyle
KW - Patient-tailored treatment
KW - Q-fever fatigue syndrome
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85136494239&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06620-2
DO - 10.1186/s13063-022-06620-2
M3 - Article
C2 - 35986408
SN - 1745-6215
VL - 23
SP - 1
EP - 14
JO - Trials
JF - Trials
IS - 1
M1 - 683
ER -