Evidence map›Paper›PMID 30869642›Full record

Trial reportJournal of medical Internet research2019

Internet-Based Cognitive Behavioral Therapy in Stepped Care for Chronic Fatigue Syndrome: Randomized Noninferiority Trial.

Margreet Worm-Smeitink, Anthonie Janse, Arno van Dam, Andrea Evers, Rosalie van der Vaart, Michel Wensing, Hans Knoop

Open access · goldAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Journal of medical Internet research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 12% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

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  6. Observational
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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 at 4 institutions in 2 countries.

Margreet Worm-SmeitinkDepartment of Medical Psychology, Radboud University Medical Center, Nijmegen, Netherlands.ORCID 0000-0002-3117-2660
Anthonie JanseDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.ORCID 0000-0002-1890-7167
Arno van DamSchool of Social and Behavioural Sciences, Tranzo, Tilburg University, Tilburg, Netherlands.ORCID 0000-0002-5604-9837
Andrea EversHealth, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.ORCID 0000-0002-0090-5091
Rosalie van der VaartHealth, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.ORCID 0000-0002-8787-4186
Michel WensingDepartment of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0001-6569-8137
Hans KnoopDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.ORCID 0000-0001-7763-3517
Amsterdam University Medical Centers · NLLeiden University · NLRadboud University Nijmegen · NLTilburg University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInternet-based cognitive behavioral therapy (I-CBT) leads to a reduction of fatigue severity and disability in adults with chronic fatigue syndrome (CFS). However, not all patients profit and it remains unclear how I-CBT is best embedded in the care of CFS patients.

objectiveThis study aimed to compare the efficacy of stepped care, using therapist-assisted I-CBT, followed by face-to-face (f2f) cognitive behavioral therapy (CBT) when needed, with f2f CBT (treatment as usual [TAU]) on fatigue severity. The secondary aim was to investigate treatment efficiency.

methodsA total of 363 CFS patients were randomized to 1 of the 3 treatment arms (n=121). There were 2 stepped care conditions that differed in the therapists' feedback during I-CBT: prescheduled or on-demand. When still severely fatigued or disabled after I-CBT, the patients were offered f2f CBT. Noninferiority of both stepped care conditions to TAU was tested using analysis of covariance. The primary outcome was fatigue severity (Checklist Individual Strength). Disabilities (Sickness Impact Profile -8), physical functioning (Medical Outcomes Survey Short Form-36), psychological distress (Symptom Checklist-90), and proportion of patients with clinically significant improvement in fatigue were the secondary outcomes. The amount of invested therapist time was compared between stepped care and TAU. Exploratory comparisons were made between the stepped care conditions of invested therapist time and proportion of patients who continued with f2f CBT.

resultsNoninferiority was indicated, as the upper boundary of the one-sided 98.75% CI of the difference in the change in fatigue severity between both forms of stepped care and TAU were below the noninferiority margin of 5.2 (4.25 and 3.81, respectively). The between-group differences on the secondary outcomes were also not significant (P=.11 to P=.79). Both stepped care formats required less therapist time than TAU (median 8 hours, 9 minutes and 7 hours, 25 minutes in stepped care vs 12 hours in TAU; P<.001). The difference in therapist time between both stepped care formats was not significant. Approximately half of the patients meeting step-up criteria for f2f CBT after I-CBT did not continue.

conclusionsStepped care, including I-CBT followed by f2f CBT when indicated, is noninferior to TAU of f2f CBT and requires less therapist time. I-CBT for CFS can be used as a first step in stepped care.

trial registrationNederlands Trial Register NTR4809; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4809 (Archived by WebCite at http://www.webcitation.org/74SWkw1V5).

Indexed as

AdultCognitive Behavioral TherapyFatigue Syndrome, ChronicFemaleHumansInternetMaleSurveys and QuestionnairesTelemedicineTreatment Outcomechronic fatigue syndromecognitive behavioral therapyeHealthrandomized controlled trial

Identifiers

PMID30869642
PMCPMC6437617
OpenAlexW2898580052

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.