Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial.

BACKGROUND: More than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-line treatment in international guidelines on sleep. Patients with rheumatoid arthritis suffer from debilitating symptoms, such as fatigue and pain, which can also be linked to sleep disturbance. It remains to be determined whether cognitive behavioural therapy for insomnia can be effective in patients with rheumatoid arthritis. The aim of the Sleep-RA trial is to investigate the efficacy of cognitive behavioural therapy for insomnia on sleep and disease-related symptoms in patients with rheumatoid arthritis. The primary objective is to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep efficiency from baseline to week 7 in patients with rheumatoid arthritis. The key secondary objectives are to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms from baseline to week 26 in patients with rheumatoid arthritis. METHODS: The Sleep-RA trial is a randomised controlled trial with a two-group parallel design. Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity will be allocated 1:1 to treatment with cognitive behavioural therapy for insomnia or usual care. Patients in the intervention group will receive nurse-led, group-based cognitive behavioural therapy for insomnia once a week for 6 weeks. Outcome assessments will be carried out at baseline, after treatment (week 7) and at follow-up (week 26). DISCUSSION: Data on treatment of insomnia in patients with rheumatoid arthritis are sparse. The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis. Because symptoms of rheumatoid arthritis and insomnia have many similarities, we also find it relevant to investigate the secondary effects of cognitive behavioural therapy for insomnia on fatigue, impact of rheumatoid arthritis, depressive symptoms, pain, functional status, health-related quality of life and disease activity. If we find cognitive behavioural therapy for insomnia to be effective in patients with rheumatoid arthritis this will add weight to the argument that evidence-based non-pharmacological treatment for insomnia in rheumatological outpatient clinics is eligible in accordance with the existing international guidelines on sleep. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03766100. Registered on 30 November 2018.

Motivational counselling and SMS-reminders for reduction of daily sitting time in patients with rheumatoid arthritis: a descriptive randomised controlled feasibility study.

BACKGROUND: Patients with rheumatoid arthritis (RA) spend a high proportion of their waking time in sedentary behaviour (SB) and have an increased risk of cardiovascular disease. Reduction of SB and increase in light intensity physical activity has been suggested as a means of improvement of health in patients with mobility problems. Short-term intervention studies have demonstrated that SB can be reduced by behavioural interventions in sedentary populations. To evaluate descriptively the feasibility of recruitment, randomisation, outcome assessments, retention and the acceptability of an individually tailored, theory-based behavioural intervention targeting reduction in daily sitting time in patients with RA. METHODS: A randomised, controlled trial with two parallel groups. RA patients >18 years of age and Health Assessment Questionnaire (HAQ) score < 2.5 were consecutively invited and screened for daily leisure time sitting > 4 h. The 16-week intervention included 1) three individual motivational counselling sessions and 2) individual text message reminders aimed at reducing daily sitting time. The control group was encouraged to maintain their usual lifestyles. Outcomes were assessed at baseline and after the 16 week intervention. Daily sitting time was measured using an ActivPAL3TM activity monitor. The study was not powered to show superiority; rather the objective was to focus on acceptability among patients and clinical health professionals. RESULTS: In total, 107 patients were invited and screened before 20 met eligibility criteria and consented; reasons for declining study participation were mostly flares, lack of time and co-morbidities. One patient from the control group dropped out before end of intervention (due to a RA flare). Intervention participants completed all counselling sessions. All procedures regarding implementation of the trial protocol were feasible. The daily sitting time was reduced on average by 0.30 h in the intervention group unlike the control group that tended to increase it by 0.15 h after 16 weeks. CONCLUSIONS: This study shows that an individually tailored behavioural intervention targeting reduction of SB was feasible and acceptable to patients with RA. TRIAL REGISTRATION: The Danish Data Protection Agency (ref.nb. 711-1-08 - 20 March 2011), the Ethics Committee of the Capital Region of Denmark (ref.nb. H-2-2012-112- 17 October 2012), clinicaltrials.gov ( NCT01969604 - October 17 2013, retrospectively registered).

Physical activity and the association with fatigue and sleep in Danish patients with rheumatoid arthritis.

The aim of this study was to examine physical activity behavior in patients with rheumatoid arthritis and to identify potential correlates of regular physical activity including fatigue, sleep, pain, physical function and disease activity. A total of 443 patients were recruited from a rheumatology outpatient clinic and included in this cross-sectional study. Physical activity was assessed by a four-class questionnaire, in addition to the Physical Activity Scale. Other instruments included the Multidimensional Fatigue Inventory (MFI), the Pittsburgh Sleep Quality Index and the Health Assessment Questionnaire. Disease activity was obtained from a nationwide clinical database. Of the included patients, 80 % were female and mean age was 60 (range 21-88 years). Hereof, 22 % (n = 96) were regularly physically active, and 78 % (n = 349) were mainly sedentary or having a low level of physical activity. An inverse univariate association was found between moderate to vigorous physical activity, and fatigue (MFI mental, MFI activity, MFI physical and MFI general), sleep, diabetes, depression, pain, patient global assessment, HAQ and disease activity. The multivariate prediction model demonstrated that fatigue-related reduced activity and physical fatigue were selected in >95 % of the bootstrap samples with median odds ratio 0.89 (2.5-97.5 % quantiles: 0.78-1.00) and 0.91 (2.5-97.5 % quantiles: 0.81-0.97), respectively, while disease activity was selected in 82 % of the bootstrap samples with median odds ratio 0.90. Moderate to vigorous physical activity in patients with rheumatoid arthritis is associated with the absence of several RA-related factors with the most important correlates being reduced activity due to fatigue, physical fatigue and disease activity.

Sleep quality and correlates of poor sleep in patients with rheumatoid arthritis.

The objective of this study is to examine sleep quality and correlates of poor sleep in patients with rheumatoid arthritis (RA). Five hundred patients with RA were recruited from a rheumatology outpatient clinic and included in this cross-sectional study. Sleep quality and disturbances were assessed using the Pittsburgh Sleep Quality Index (PSQI). Other instruments included the Multidimensional Fatigue Inventory, the Epworth Sleepiness Scale, and the Health Assessment Questionnaire. Disease activity was assessed according to disease activity score DAS28-CRP-based. Complete scores on PSQI were obtained from 384 patients (77 %). In those, the prevalence of poor sleep (PSQI >5) was 61 %, and the mean global PSQI score was 7.54 (SD 4.17). A linear association was found between poor sleep and mental fatigue, reduced activity related to fatigue, physical fatigue, and general fatigue. Mental fatigue and general fatigue were independently associated with sleep quality, sleep latency, sleep duration, sleep efficiency, and daytime dysfunction. However, in the linear multivariate analysis, only general fatigue 1.06 (95 % CI 1.03-1.09) and mental fatigue 1.03 (95 % CI 1.01-1.05) were found to be significant correlates for reporting poor sleep. This study shows that a majority of patients with RA experience poor sleep and that general fatigue and mental fatigue are associated with poor sleep.