Cognitive behavioral therapy improves physical function and fatigue in mild and moderate chronic fatigue syndrome : A consecutive randomized controlled trial of standard and short interventions

Objective: To study whether standard cognitive behavioral therapy (CBT) and a shorter, interpersonal oriented cognitive behavioral therapy (I-CBT) can improve physical function and fatigue in patients diagnosed with mild to moderate chronic fatigue syndrome (CFS) in a multidisciplinary fatigue clinic. Design: Consecutively 236 participants 18–62 years old meeting the Centre of Decease Control, CDC 1994 criteria, with a subsample also fulfilling the Canadian criteria for CFS, were randomly allocated to one of three groups. Two intervention groups received either 16 weeks of standard CBT or 8 weeks of I-CBT vs. a waiting-list control group (WLC). Primary outcome was the subscale Physical Function (PF) from SF-36 (0–100). Secondary outcome was amongst others fatigue measured by Chalder Fatigue Questionnaire (CFQ) (0–33). Outcomes were repeatedly measured up to 52 weeks from baseline. Results: The additional effect relative to baseline at post-intervention for SF-36 physical function was 14.2 (95% CI 7.9–20.4 p < 0.001) points higher for standard CBT and 6.8 (0.5–13.2 p = 0.036) points higher for I-CBT compared with the control group. The additional effect relative to baseline at post-intervention for fatigue was 5.9 (95% CI 0.5–10.5 p = 0.03) points lower for standard CBT compared with the control group but did not differ substantially for I-CBT 4.8 (95% CI −0.4 to 9.9 p = 0.07). The positive change in physical function persisted at 1-year follow-up for both treatment groups, and for standard CBT also in fatigue. The two intervention groups did not differ significantly in self-reported physical function and fatigue at the 1-year follow-up. No serious adverse reactions were recorded in any of the groups during the trial period. Interpretation: A 16-week standard, individual CBT intervention improves physical function and fatigue in CFS outpatients with mild to moderate disease. A shorter 8-week I-CBT program improves physical function. Both treatments are safe, and the effect persist 1 year after baseline. Clinical Trial registration: ClinicalTrials.gov, Identifier: NCT00920777, registered June 15, 2009.publishedVersio

The Norwegian PraksisNett: a nationwide practice-based research network with a novel IT infrastructure

Clinical research in primary care is relatively scarce. Practice-based research networks (PBRNs) are research infrastructures to overcome hurdles associated with conducting studies in primary care. In Norway, almost all 5.4 million inhabitants have access to a general practitioner (GP) through a patient-list system. This gives opportunity for a PBRN with reliable information about the general population. The aim of the current paper is to describe the establishment, organization and function of PraksisNett (the Norwegian Primary Care Research Network). Materials and Methods We describe the development, funding and logistics of PraksisNett as a nationwide PBRN. Results PraksisNett received funding from the Research Council of Norway for an establishment period of five years (2018–2022). It is comprised of two parts; a human infrastructure (employees, including academic GPs) organized as four regional nodes and a coordinating node and an IT infrastructure comprised by the Snow system in conjunction with the Medrave M4 system. The core of the infrastructure is the 92 general practices that are contractually linked to PraksisNett. These include 492 GPs, serving almost 520,000 patients. Practices were recruited during 2019–2020 and comprise a representative mix of rural and urban settings spread throughout all regions of Norway. Conclusion Norway has established a nationwide PBRN to reduce hurdles for conducting clinical studies in primary care. Improved infrastructure for clinical studies in primary care is expected to increase the attractiveness for studies on the management of disorders and diseases in primary care and facilitate international research collaboration. This will benefit both patients, GPs and society in terms of improved quality of care.publishedVersio

Effectiveness of 'motivational interviewing' on sick leave: a randomized controlled trial in a social insurance setting

Objective This study aimed to evaluate the effectiveness of motivational interviewing (MI) – a counselling approach offered by caseworkers at the Norwegian Labor and Welfare Administration (NAV) – on return to work (RTW) for individuals sick-listed for ≥8 weeks due to any diagnoses. MI was compared to usual case management and an active control during 12 months of follow-up. Methods In a randomized clinical trial with three parallel arms, participants were randomized to MI (N=257), usual case management (N=266), or an active control group (N=252). MI consisted of two MI sessions while the active control involved two sessions without MI, both were offered in addition to usual case management. The primary outcome was number of sickness absence days based on registry data. Secondary outcomes included time to sustainable RTW, defined as four consecutive weeks without medical benefits. Results The median number of sickness absence days for the MI group was 73 days [interquartile range (IQR) 31–147], 76 days (35–134) for usual care, and 75 days (34–155) for active control. In total 89%, 88% and 86% of the participants, respectively, achieved sustainable RTW. The adjusted hazard ratio (HR) for time to sustainable RTW was 1.12 (95% CI 0.90–1.40) for MI compared to usual case management and HR 1.16 (95% CI 0.93–1.44) compared to the active control. Conclusions This study did not provide evidence that MI offered by NAV caseworkers to sick-listed individuals was more effective on RTW than usual case management or an active control. Providing MI in this context could be challenging as only half of the MI group received the intervention.publishedVersio

Chronic fatigue syndromes: real illnesses that people can recover from

The ‘Oslo Chronic Fatigue Consortium’ consists of researchers and clinicians who question the current narrative that chronic fatigue syndromes, including post-covid conditions, are incurable diseases. Instead, we propose an alternative view, based on research, which offers more hope to patients. Whilst we regard the symptoms of these conditions as real, we propose that they are more likely to reflect the brain's response to a range of biological, psychological, and social factors, rather than a specific disease process. Possible causes include persistent activation of the neurobiological stress response, accompanied by associated changes in immunological, hormonal, cognitive and behavioural domains. We further propose that the symptoms are more likely to persist if they are perceived as threatening, and all activities that are perceived to worsen them are avoided. We also question the idea that the best way to cope with the illness is by prolonged rest, social isolation, and sensory deprivation. Instead, we propose that recovery is often possible if patients are helped to adopt a less threatening understanding of their symptoms and are supported in a gradual return to normal activities. Finally, we call for a much more open and constructive dialogue about these conditions. This dialogue should include a wider range of views, including those of patients who have recovered from them

Contextual and time dependent pain in fibromyalgia: An explorative study

Background Little is known about contextual effects on chronic pain, and how vulnerability factors influence pain in different contexts. We wanted to examine if fibromyalgia (FM) pain varied between two social contexts, i.e. at home versus in a doctor office, when it was measured the same day, and if pain was stable for 14 years when measured in similar contexts (doctor office). Our secondary aim was to explore if pain vulnerability factors varied in the two different contexts. Findings Fifty-five female FM patients were included in the study and scored pain in both contexts at baseline. Their age ranged between 21–68 years (mean 45.7), mean education level was 11 years and mean FM-duration was 15.6 years. Their mean pain was perceived significantly lower at home than in a doctor context the same day. However, pain was much more stable when measured in two similar contexts 14 year apart where 30 subjects (54.5%) completed. Predictor analyses revealed that pain vulnerability factors apparently varied by home and doctor contexts. Conclusion Pain and pain predictors seem to vary by contexts and time, with less pain at home than to a doctor the same day, but with unchanged pain in the same context after 14 years. Thus, contextual pain cues should be accounted for when pain is measured and treated, e.g. by focusing more on home-measured pain and by optimizing the doctor office context. This explorative study should be followed up by a larger full-scale study

Patients with Fibromyalgia and Chronic Fatigue Syndrome show increased hsCRP compared to healthy controls

Chronic Fatigue Syndrome (CFS) and Fibromyalgia (FM) are both chronic disorders that have a devastating effect on the lives of the affected patients and their families. Both conditions have overlapping clinical features that partly resemble those of inflammatory disorders. The etiology is still not understood, and it is suggested that the immune system might be a contributing factor. So far, the results are inconclusive. The purpose of this study was to compare the two conditions and investigate the level of the inflammatory marker high-sensitivity CRP (hsCRP) in CFS and FM patients compared to healthy controls. Female participants aged 18–60 years were enrolled in this study. The group consisted of 49 CFS patients, 57 FM patients, and 54 healthy controls. hsCRP levels were significantly higher for both the CFS and the FM groups compared to healthy controls when adjusting for age, smoking, and BMI (p < .001). There was no difference between the two patient groups. The level of hsCRP was affected by BMI but not by age and smoking. Patients with CFS and FM have higher concentrations of hsCRP compared to healthy controls. This remains significant even after adjusting for BMI. CFS and FM cannot be distinguished from each other on the basis of hsCRP in our study

A concurrent cognitive task does not perturb quiet standing in fibromyalgia and chronic fatigue syndrome

Background and Objectives. Cognitive complaints are common in fibromyalgia (FM) and chronic fatigue syndrome (CFS). Fatigue as well as pain may require greater effort to perform cognitive tasks, thereby increasing the load on processing in the central nervous system and interfering with motor control. Methods. The effect of a concurrent arithmetic cognitive task on postural control during quiet standing was investigated in 75 women (aged 19–49 years) and compared between FM, CFS, and matched controls (/group). Quiet standing on a force plate was performed for 60 s/condition, with and without a concurrent cognitive task. The center of pressure data was decomposed into a slow component and a fast component representing postural sway and adjusting ankle torque. Results. Compared to controls, CFS and FM displayed lower frequency in the slow component (), and CFS displayed greater amplitude in the slow ( and ) and fast () components. There were no interactions indicating different responses to the added cognitive task between any of the three groups. Conclusion. Patients displayed insufficient postural control across both conditions, while the concurrent cognitive task did not perturb quiet standing. Fatigue but not pain correlated with postural control variables

Concordance between clinician- and 2016 criteria- based diagnoses of fibromyalgia

Objectives The Fibromyalgia Survey Diagnostic Criteria-2016 (FSD-2016 criteria) were recently recommended for both clinical and research purposes. The present study aims to examine whether there is concordance between clinician-based and FSD-2016 criteria-based diagnoses of FM, and secondly, to examine how the illness severity and physical function relate to the criteria-based diagnosis among patients referred to a rheumatism hospital. Methods Participants with a clinician-based diagnosis of FM were included consecutively when referred to a patient education programme for patients with FM. Illness severity was assessed with the Fibromyalgia Survey Questionnaire (FSQ). Based on the FSQ, the fulfilment of the FSD-2016 criteria was evaluated. Physical function was assessed using the Fibromyalgia Impact Questionnaire (FIQ) function scale and self-reported employment status. Results The sample included 130 patients (84% women) from 20 to 66 years of age. Eighty-nine per cent met the FSD-2016 criteria, and 44% of the patients were fully or partially employed. Great variability in illness severity was seen irrespective of employment status. There was an association between illness severity and physical function (r=0.4, p<0.001). For 95% of the patients, the FSQ illness severity scores classify as severe or very severe, and even for those not fulfilling the diagnostic criteria the scores were moderate and severe. Conclusions There was relatively high agreement between clinician- and criteria-based diagnoses. The illness severity overlapped irrespective of different employment status and fulfilment of FSD-2016 criteria

Pain acceptance and its impact on function and symptoms in fibromyalgia

Objectives Fibromyalgia is a chronic widespread pain (CWP) syndrome of unknown etiology with substantial burden of illness and functional impairment. Pain acceptance has emerged as an interesting target of therapy in chronic pain populations, but few studies have yet been done on the effect of pain acceptance on patients with fibromyalgia. The aim of the present study was to examine the relationship between pain acceptance and its impact on function and symptoms in fibromyalgia with both a cross-sectional and longitudinal design. Methods Three hundred and sixty five participants aged 22–70 with fibromyalgia were recruited from the Norwegian Fibromyalgia Association (NFA). They filled out a questionnaire containing the Fibromyalgia Impact Questionnaire (FIQ), measurement of function and symptoms, and Chronic Pain Acceptance Questionnaire (CPAQ), measurement of pain acceptance, in addition to sociodemographic and clinical variables such as degree of fibromyalgia, depression and pain duration (T1 measures). One year after, 87 of the participants filled out the FIQ and clinical measures once again (T2 measures). Unadjusted and adjusted linear regression analyses were performed both for cross-sectional measures at T1 and for longitudinal measures from T1 to T2, with FIQ score as the outcome variable and CPAQ score at T1 as one of the main independent variables. Results Higher CPAQ score was significantly associated with a lower FIQ score at T1, also when adjusting for age, education, work, depression and Fibromyalgianess Score (p<0.01). Lower FIQ score indicate less impact of fibromyalgia on functioning. In addition, two adjusted linear regression models found higher pain acceptance (CPAQ score) at T1 to be associated with lower negative impact of fibromyalgia on function and symptoms (FIQ score) at T2 (p<0.01). Conclusions Higher pain acceptance is associated with better functional level and less symptoms in fibromyalgia, both cross-sectionally and when measurements are separated in time. Further research should include experimental studies with acceptance-based interventions for this patient group

MCP-1 is increased in patients with CFS and FM, whilst several other immune markers are significantly lower than healthy controls

The role of the immune system in the pathogenesis of Fibromyalgia (FM) and Chronic fatigue syndrome (CFS) is not clear. We have previously reported increased levels of C-reactive protein (CRP) in these patient groups compared to healthy controls and wanted to further explore the levels of circulating immune markers in these populations.The population consisted of three groups, 58 patients with FM, 49 with CFS and 54 healthy controls. All participants were females aged 18–60. Patients were recruited from a specialised university hospital clinic and controls were recruited by advertisement among the staff and students at the hospital and university. Plasma levels of Interferon (IFN)-γ, Interleukin (IL)-1β, IL-1ra, IL-4, IL-6, IL-8, IL-10, IL-17, Interferon gamma-induced protein (IP)-10, Monocyte Chemoattractant Protein (MCP)-1, Transforming Growth Factor (TGF)-β1, TGF-β2, TGF-β3 and Tumour Necrosis Factor (TNF)-α were analysed by multiplex. Differences between the three groups CFS, FM and controls, were analysed by Kruskal Wallis tests.MCP-1 was significantly increased in both patient groups compared to healthy controls. IL-1β, Il-4, IL-6, TNF-α, TGF-β1, TGF-β2, TGF-β3, IL-10 and IL17 all were significantly lower in the patient groups than healthy controls. IFN-γ was significantly lower in the FM group. For IL-8, IL-10 and IL-1ra there were no significant difference when controlled for multiple testing.In conclusion, in our material MCP-1 seems to be increased in patients both with CFS and with FM, while several other immune markers are significantly lower in patients than controls