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

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 randomized controlled trial using a parallel group design, the experimental intervention was 6 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, -7.92]) and the RA impact of disease (RAID: -1.36 [95% CI -1.92, -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.

Impact of Nonpharmacologic Interventions Targeting Sleep Disturbances or Disorders in Patients With Inflammatory Arthritis: A Systematic Review and Meta-Analysis of Randomized Trials.

OBJECTIVE: Patients with inflammatory arthritis have a high risk of sleep disturbances and disorders. The objective was to evaluate the evidence of nonpharmacologic interventions targeting sleep disturbances or disorders in patients with inflammatory arthritis. METHODS: A systematic search was undertaken from inception to September 8, 2020. We included randomized trials concerning nonpharmacologic interventions applied in adults with inflammatory arthritis and concomitant sleep disturbances or disorders. The primary outcome was the sleep domain, while secondary outcomes were core outcome domains for inflammatory arthritis trials and harms. The Cochrane Risk of Bias tool was applied, and the overall quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation criteria. Effect sizes for continuous outcomes were based on the standardized mean difference, combined using random-effects meta-analysis. RESULTS: Six trials (308 patients) were included in the quantitative synthesis; 3 of these reported improvement in sleep in favor of the nonpharmacologic interventions. The meta-analysis of the sleep domains indicated a large clinical effect of -0.80 (95% confidence interval -1.33, -0.28) in favor of nonpharmacologic interventions targeting sleep disturbances or disorders. The estimate was rated down twice for risk of bias and unexplained inconsistency; this risk was assessed as corresponding to low-quality evidence. None of the secondary core outcomes used in contemporary inflammatory arthritis trials indicated a clinical benefit in favor of nonpharmacologic interventions targeting sleep. CONCLUSION: Nonpharmacologic interventions targeting sleep disturbances/disorders in patients with inflammatory arthritis indicated a promising effect on sleep outcomes, but not yet with convincing evidence.

First use of antidepressant medication in male partners of women with breast cancer in Denmark from 1998 to 2011.

OBJECTIVE: A diagnosis of breast cancer disrupts the life of the patient, but also the partner may experience adverse psychological effects. We examined partners' risk for first use of antidepressant medication, as a proxy for pharmacologically treated depression. METHODS: By linkage of national registers, we identified 1 420 592 depression-free men living with a cancer-free female partner in 1998 to 2011. During follow-up, breast cancer was diagnosed in female partners of 26 256 men. In Poisson regression models, we estimated the rate ratios for first use of antidepressant medication compared to partners of breast cancer-free women. Cox regression analyses examined associations between exposed partners' sociodemographic characteristics, somatic comorbidity, death of female partner, and first use of antidepressant medication. RESULTS: Male partners of women with breast cancer had an increased rate ratio of 1.08 (95% CI, 1.03-1.13) for first use of antidepressant medication compared to the background population, corresponding to excess absolute risk of 12 cases per 10 000 person-years. This increased risk persisted throughout 14 years of follow-up. Higher age, shorter education, somatic comorbidity, and death of female partner were associated with increased risk among men whose partner had breast cancer. CONCLUSION: The modest, but long term, increased risk for first use of antidepressant medication calls for attention by health care professionals to symptoms of depression among partners of breast cancer patients.