Transdiagnostic cognitive behavioral therapy for severe and persistent fatigue – a feasibility study in primary care, 2026, Svärdman et al

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Transdiagnostic cognitive behavioral therapy for severe and persistent fatigue – a feasibility study in primary care

Frank Svärdman, Conrad Samuelsson, Ludwig Franke Föyen, Anna Oremark, Anna Högfeldt, Jacob Andersson Emad, Douglas Sjöwall, Christian Rück, Erik Hedman-Lagerlöf, Hans Knoop, Elin Lindsäter

Background
Fatigue is the main complaint of 5–10% of patients in primary care and is often associated with significant suffering and functional disability. Cognitive behavioral therapy (CBT) has demonstrated efficacy in reducing fatigue severity in diverse clinical populations in specialized healthcare settings, with common treatment mechanisms identified across conditions. This study is the first to evaluate the feasibility and acceptability of a transdiagnostic CBT (tCBT) for a heterogeneous sample of patients suffering from severe and persistent fatigue in a primary care context.

Methods
A single-arm feasibility study was conducted in routine primary care. Adults with severe and persistent fatigue received a blended tCBT combining individual sessions and internet-based materials. Feasibility and acceptability were evaluated through adherence, completion, attrition, therapist fidelity, patient satisfaction, credibility, and negative effects. Preliminary effectiveness was evaluated by self-reported symptom change from pre- to post-treatment (6 months).

Results
Eighteen participants were enrolled, of whom fourteen completed the full intervention. Treatment adherence and therapist fidelity were satisfactory, and data attrition was minimal. Participants reported high satisfaction and treatment credibility. No serious adverse events were reported. Half of the participants reported some negative effects of treatment, primarily consisting of transient increases in fatigue and sleep disturbances. Large within-group reductions were observed in self-reported fatigue severity and functional impairment over the 6-month treatment period.

Conclusions
Preliminary findings suggest that tCBT for fatigue is feasible and acceptable in a primary care setting. Interpretation is limited by the small sample size and single-arm design. Larger randomized controlled trials are warranted to evaluate effectiveness and to determine which patients benefit most and through which mechanisms.

Trial registration
Pre-registered on Clinicaltrials.gov (NCT06341751), registration date: 2024-03-13.

Web | DOI | PDF | BMC Primary Care | Open Access
 
"The intervention included gradual increases in physical activity introduced in small, individualized increments and was not strictly symptom contingent. Progression was collaboratively negotiated and flexibly adjusted, rather than delivered as a fixed incremental schedule. Of note, however, the intervention differs from parts of the NICE guidance for ME/CFS [35] in that symptom fluctuations were not used as the primary determinant of activity progression. While many participants reported improvement, and an individual patient data meta-analysis found no indication that ME/CFS patients who reported PEM benefitted less from CBT [36], this feasibility study does not allow conclusions regarding safety or effectiveness for individuals with ME/CFS or PEM specifically. Accordingly, the findings should be interpreted as informing of feasibility and acceptability only."
 
I'm not sure how many of the participants had ME/CFS, but a few of the free text responses for negative effects in the supplementary file talk about crashes or something like a crash:
Participant 4
“The increase in activity happened too quickly. My body couldn't keep up with the pace, and it resulted in a rather significant crash. Unfortunately, I don't think people with ME can be helped by this type of treatment”
Participant 5
“The negative part was when I crashed due to too much activity.”
Participant 6
"I injured myself physically several times during the period when I didn't rest during the day, experienced dizziness and palpitations, had difficulty understanding simple instructions and having normal conversations with my family. I got increased muscle weakness when I didn't rest."
 
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