Randomised Controlled Trial of Cognitive Behaviour Therapy Delivered in Groups of Patients with Chronic Fatigue Syndrome

Abstract

Background: Meta-analyses have been inconclusive about the efficacy of cognitive behaviour therapies (CBTs) delivered in groups of patients with chronic fatigue syndrome (CFS) due to a lack of adequate studies. Methods: We conducted a pragmatic randomised controlled trial with 204 adult CFS patients from our routine clinical practice who were willing to receive group therapy. Patients were equally allocated to therapy groups of 8 patients and 2 therapists, 4 patients and 1 therapist or a waiting list control condition. Primary analysis was based on the intention-to-treat principle and compared the intervention group (n = 136) with the waiting list condition (n = 68). The study was open label. Results: Thirty-four (17%) patients were lost to follow-up during the course of the trial. Missing data were imputed using mean proportions of improvement based on the outcome scores of similar patients with a second assessment. Large and significant improvement in favour of the intervention group was found on fatigue severity (effect size = 1.1) and overall impairment (effect size = 0.9) at the second assessment. Physical functioning and psychological distress improved moderately (effect size = 0.5). Treatment effects remained significant in sensitivity and per-protocol analyses. Subgroup analysis revealed that the effects of the intervention also remained significant when both group sizes (i.e. 4 and 8 patients) were compared separately with the waiting list condition. Conclusions: CBT can be effectively delivered in groups of CFS patients. Group size does not seem to affect the general efficacy of the intervention which is of importance for settings in which large treatment groups are not feasible due to limited referral.

Effectiveness of Long-term Doxycycline Treatment and Cognitive-Behavioral Therapy on Fatigue Severity in Patients with Q Fever Fatigue Syndrome (Qure Study): A Randomized Controlled Trial

“…Although CBT proved effective in reducing fatigue and psychological distress in QFS patients as well, it remains unclear whether the process of change during CBT in QFS is similar to that in CFS [31]. Different processes involved in the perpetuation of disabilities might explain the absence of effect of CBT on functional impairment, for which CBT for CFS has proven efficacy [32][33][34]. However, this might also be due to the inclusion of patients with moderate levels of overall impairment (SIP8 total score ≥450) [32][33][34] and, thus, less opportunity for improvement.…”

“…Different processes involved in the perpetuation of disabilities might explain the absence of effect of CBT on functional impairment, for which CBT for CFS has proven efficacy [32][33][34]. However, this might also be due to the inclusion of patients with moderate levels of overall impairment (SIP8 total score ≥450) [32][33][34] and, thus, less opportunity for improvement. The mean number of AEs per patient was lowest in the CBT group, and no SAE occurred in this group.…”

Group Cognitive Behaviour Therapy for Chronic Fatigue Syndrome

“…Furthermore, in the baseline characteristics of the study sample of Wiborg et al [1], we noticed that the secondary outcome measure, i.e. psychological distress as measured with the Symptom Checklist 90, was low compared to the baseline value we obtained in our own population receiving treatment in a tertiary CFS centre [4], whilst the scores on the Checklist Individual Strength were comparable for the two samples (table 1).…”

“…We have read the article entitled ‘Randomised controlled trial of cognitive behaviour therapy delivered in groups of patients with chronic fatigue syndrome' by Wiborg et al [1] with much interest. The authors report that their randomised controlled trial showed that group cognitive behaviour therapy (CBT) can be effectively delivered to adults suffering from chronic fatigue syndrome (CFS), independently of group size.…”

“…psychological distress as measured with the Symptom Checklist 90, was low compared to the baseline value we obtained in our own population receiving treatment in a tertiary CFS centre [4], whilst the scores on the Checklist Individual Strength were comparable for the two samples (table 1). We accordingly wonder whether the results of the study of Wiborg et al [1] are representative of the daily practice in tertiary settings given that research has already shown that randomised controlled study outcomes are superior to those obtained in routine clinical practice, where the disparity may be explained by patient selection [5]. …”