The effect of group-based cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: a randomized controlled trial

Abstract

Objectives The primary objective was to compare the effect of cognitive behavioural therapy for insomnia (CBT-I) to usual care on sleep efficiency, measured by polysomnography (PSG) immediately after the intervention at week 7. Secondary objectives included comparing the longer-term effect on sleep- and RA-related outcomes at week 26. Methods In a randomised controlled trial using a parallel group design, the experimental intervention was six weeks’ nurse-led group-based CBT-I; the comparator was usual care. Analyses were based on the intention-to-treat (ITT) principle; missing data were statistically modelled using repeated-measures linear mixed effects models adjusted for the level at baseline. Results The ITT population consisted of 62 patients (89% women), with an average age of 58 years and an average sleep efficiency of 83.1%. At primary end point, sleep efficiency was 88.7% in the CBT-I group, compared with 83.7% in the control group (difference: 5.03 [95% CI -0.37–10.43]; p = 0.068) measured by PSG at week 7. Key secondary outcomes measured with PSG had not improved at week 26. However, for all the patient-reported key secondary sleep- and RA-related outcomes, there were statistically highly significant differences between CBT-I and usual care (p < 0.0001), e.g. insomnia (Insomnia Severity Index: -9.85 [95% CI -11.77 to -7.92]), and the RA impact of disease (RAID: -1.36 [95% CI-1.92 to -0.80]) at week 26. Conclusion Nurse-led group-based CBT-I did not lead to an effect on sleep efficiency objectively measured with PSG. However, CBT-I showed improvement on all patient-reported key secondary sleep- and RA-related outcomes measured at week 26. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT03766100.

Experiences of group-based cognitive behavioural therapy for insomnia among patients with rheumatoid arthritis: a qualitative study

“… 30 All participants had previously participated in the intervention group in the above-mentioned RCT. 28 The RCT had a two-group parallel design with participants allocated 1:1 to either CBT-I (intervention) or usual care with no protocolised treatment for insomnia as a comparator (control). The intervention in the RCT was face-to-face group CBT-I with attendance 2 hours per week for 6 weeks, and a health professional (HP) facilitated the sessions, CBT-I trained and registered nurse.…”

“…More information about the intervention is published elsewhere. 28 The content of the CBT-I intervention can be found in table 1 .…”

“…The participants were diagnosed with RA (according to the ACR(American College of Rheumatology)/EULAR (European Alliance of Associations for Rheumatology) 2010 criteria)29 and had low-to-moderate disease activity (DAS28-CRP ≤5.1) 30. All participants had previously participated in the intervention group in the above-mentioned RCT 28. The RCT had a two-group parallel design with participants allocated 1:1 to either CBT-I (intervention) or usual care with no protocolised treatment for insomnia as a comparator (control).…”

“…The sessions comprised presentations, instructions and assignments, questions, clarifications, sharing of participants’ experiences and reflections on how to use the knowledge. More information about the intervention is published elsewhere 28. The content of the CBT-I intervention can be found in table 1.…”

“…Therefore, we have tested a group-based CBT-I in a randomised controlled trial (RCT) (NCT03766100). 27 28 We intended to explore and evaluate how participants experienced the CBT-I intervention provided in the RCT, and how they described their possible benefits from the intervention. Furthermore, we wished to explore the patients’ knowledge and usage of the different components of CBT-I.…”