Internet-Based Cognitive Behavioral Therapy for Chronic Fatigue Syndrome Integrated in Routine Clinical Care: Implementation Study
Authors: Margreet Worm-Smeitink
Andrea Evers
Arno van Dam
Hans Knoop
Saskia van Es
Michel Wensing
Rosalie van der Vaart
Journal: Journal of medical Internet research (2019)
Discipline: CLINICAL MEDICINE
Keywords: attitudes; chronic fatigue syndrome; cognitive behavioral therapy; eHealth; health plan implementation.
Affiliations: Expert Center for Chronic Fatigue, Department of Medical Psychology, University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands., Department of Medical Psychology, Radboud University Medical Center, Nijmegen, Netherlands., Specialist Center for Complex Medically Unexplained Symptoms and Somatic Symptom Disorders, Dimence, Deventer, Netherlands., Tranzo, School of Social and Behavioural Sciences, Tilburg University, Tilburg, Netherlands., GGZ-Westelijk Noord Brabant, Institute for Mental Health, Bergen op Zoom, Netherlands., PsyQ Somatiek en Psyche, Parnassia Groep, Amsterdam, Netherlands., Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands., Department of Psychiatry, Leiden University Medical Center, Leiden, Netherlands., Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany., Radboud Institute of Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands., Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.

Abstract:  Background: In a clinical trial, internet-based cognitive behavioral therapy (I-CBT) embedded in stepped care was established as noninferior to face-to-face cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS). However, treatment effects observed in clinical trials may not necessarily be retained after implementation. Objective: This study aimed to investigate whether stepped care for CFS starting with I-CBT, followed by face-to-face CBT, if needed, was also effective in routine clinical care. Another objective was to explore the role of therapists' attitudes toward electronic health (eHealth) and manualized treatment on treatment outcome. Methods: I-CBT was implemented in five mental health care centers (MHCs) with nine treatment sites throughout the Netherlands. All patients with CFS were offered I-CBT, followed by face-to-face CBT if still severely fatigued or disabled after I-CBT. Outcomes were the Checklist Individual Strength, physical and social functioning (Short-Form 36), and limitations in daily functioning according to the Work and Social Adjustment Scale. The change scores (pre to post stepped care) were compared with a benchmark: stepped care from a randomized controlled trial (RCT) testing this treatment format. We calculated correlations of therapists' attitudes toward manualized treatment and eHealth with reduction of fatigue severity. Results: Overall, 100 CFS patients were referred to the centers. Of them, 79 started with I-CBT, 20 commenced directly with face-to-face CBT, and one did not start at all. After I-CBT, 48 patients met step-up criteria; of them, 11 stepped up to face-to-face CBT. Increase in physical functioning (score of 13.4), social functioning (20.4), and reduction of limitations (10.3) after stepped care delivered in routine clinical care fell within the benchmarks of the RCT (95% CIs: 12.8-17.6; 25.2-7.8; and 7.4-9.8, respectively). Reduction of fatigue severity in the MHCs was smaller (12.6) than in the RCT (95% CI 13.2-16.5). After I-CBT only, reduction of fatigue severity (13.2) fell within the benchmark of I-CBT alone (95% CI 11.1-14.2). Twenty therapists treated between one and 18 patients. Therapists were divided into two groups: one with the largest median reduction of fatigue and one with the smallest. Patients treated by the first group had a significantly larger reduction of fatigue severity (15.7 vs 9.0; t=2.42; P=.02). There were no (statistically significant) correlations between therapists' attitudes and reduction in fatigue. Conclusions: This study is one of the first to evaluate stepped care with I-CBT as a first step in routine clinical care. Although fatigue severity and disabilities were reduced, reduction of fatigue severity appeared smaller than in the clinical trial. Further development of the treatment should aim at avoiding dropout and encouraging stepping up after I-CBT with limited results. Median reduction of fatigue severity varied largely between therapists. Further research will help understand the role of therapists' attitudes in treatment outcome. 

Retracted: No

PubPeer comments:
 The study is open-label and the primary outcome is subjective, hence the study is exposed to great bias. However, it is the patient cohort which cause the greatest concern. In 2015, National Academy of Medicine (NAM, former IOM) published their u201cBeyond Myalgic Encephalomyelitis Chronic Fatigue Syndrome: Redefining an Illnessu201d. Among other, the NAM-report state that post-exertional malaise (PEM) is a hallmark of ME, and a mandatory symptom for the ME-diagnosis. The consequences of NAMu2019 conclusion is that case criteria including PEM as a mandatory symptom (like CCC, ICC or SEID) have to be used in recruiting study participants. https: www.nap.edu catalog 19012 beyond-myalgic-encephalomyelitischronic-fatigue-syndrome-redefining-an-illness This paper does not use diagnostic criteria were PEM is a mandatory symptom, as described by NAM. Consequently, the study does not necessarily include ME-patients, and for that reason do not have any relevance in understanding the disease, treatment, and care of ME-patients. Summary: This study suffers from bias due to poor study design and caused by the use of improper case criteria, the patients are a very heterogeneous group not necessarily suffering from ME. For others intending to study ME and ME-patients, citing this paper should be done with caution! ,