Patients in the FINE Trial were randomized to one of three treatment arms: pragmatic rehabilitation (PR) or supportive listening (SL), each delivered with treatment as usual from the general practitioner (TAU), or TAU alone. The two active therapies (PR and SL) were delivered by three general nurses specially trained for the study, with all three nurses delivering both therapies. The three nurses, all female, were all experienced registered nurse practitioners who had worked in primary care settings for many years, but who did not have a specialist interest in CFS prior to their employment on the trial. They were not qualified CBT therapists and had not delivered psychological therapy of this type previously. The nurses received training over a six month period in research on CFS, the delivery of the interventions, and working to a protocol. Training involved supervised practice, role play and discussions. At the end of training the nurses’ competence to deliver the interventions was assessed as satisfactory on the basis of their performance in the practice therapy sessions. The therapists received regular supervision during the delivery of the interventions. Fidelity to the treatment approaches was assessed from randomly selected audiotapes of therapy sessions and was judged to be good by independent raters.
Randomization was carried out by an independent telephone randomization service based at the Christie Hospital Clinical Trials Unit in Manchester, using randomised permuted blocks (with randomly-varying block sizes of 9, 12, 15 or 18), after stratification on two variables—whether or not the patient was non-ambulatory, defined as using a mobility aid on most days, and whether or not the patient fulfilled the London criteria for a diagnosis of ME [5, 30]. The purpose of stratification on ambulatory status and London ME criteria was in order to address the possibility that those with a higher degree of disability and those who fulfilled the London ME criteria might be different from the rest of the sample. A randomized assignment of therapist was employed, with patients assigned to therapists in a simple random fashion constrained only by the availability of the therapists.
One hundred and ninety six participants, aged 18 and over and diagnosed with CFS/ME using the Oxford criteria [1], were randomized, 95 to PR and 101 to SL. The remaining 100 were randomized to TAU alone, but the TAU group is not included in the current analysis, as these patients were simply continuing standard contact with their GPs and did not meet a therapist but, more importantly, because they are a common control group for all three therapists, their data do not contribute any information concerning treatment effect heterogeneity arising from therapist effects. Patients were excluded from the FINE Trial if they fulfilled diagnostic criteria for antisocial, borderline, or paranoid personality disorders, had active suicidal ideation, were unable to read or write English, were currently undertaking systematic psychological therapies for CFS/ME, or had received pragmatic rehabilitation in the past year. Further details of the FINE trial sample and procedures, and a figure showing participant progression through the study are available in the main trial protocol and write-up [5, 30]. The FINE study was granted ethical approval by Eastern MREC (03/05/62). The data were anonymized prior to analysis. As a secondary analysis of an anonymized and de-identified clinical trial dataset, no further ethical approval was required for this study.
A brief version of the California Psychotherapeutic Alliance Scale (CALPAS) was completed by patients one week and 10 weeks after the start of therapy. Patients were asked to complete their forms confidentially at home and return them to the trial office by post following completion. The scale measured alliance using 5 items, each rated for agreement on an 11 point scale ranging from 0 (not at all) -100 (very much). Items asked about the therapists’ desire to understand the patient, therapist-patient agreement on goals, whether the treatment matched the patient’s ideas about helpful treatment approaches, joint working with the therapist and satisfaction with services received. The scale total score was the mean score on the five items. Here we present findings from the one week CALPAS measure only. We also analysed one of the items, measuring task alliance, separately, to enable comparison with other studies.
Primary outcomes in the FINE Trial were self-reported physical functioning, measured using the 8-item physical functioning scale of The Short Form (36) Health Survey (SF-36) [33] and fatigue, measured using the Chalder fatigue scale [34]. In accordance with usual practice, SF-36 physical functioning scores were calculated from answers to ten questions about how much the participants health limited their activities, each question scored 0 (limited a lot), 1 (limited a little), or 2 (not limited at all), then summed and converted to a percentage. The 11 items of the Chalder fatigue scale ask about problems with physical and mental fatigue over the past three weeks, and have a response format “less than usual, no more than usual, more than usual and much more than usual”. Each item may be scored—either 0011 or 0123, and then the items summed to obtain a total fatigue scale score . When scored 0011, a score of 4 or more indicated clinically significant levels of fatigue . Both methods of scoring were used in the present study. Both primary outcomes were assessed at the end of treatment and one year following the end of treatment (20 and 70 weeks).
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