Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial.

BACKGROUND: Chronic insomnia is common in patients undergoing in-center hemodialysis, yet there is limited evidence on effective treatments for this population. OBJECTIVE: To compare the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), trazodone, and placebo for insomnia in patients undergoing long-term hemodialysis. DESIGN: Randomized, multicenter, double-blinded, placebo-controlled trial. (ClinicalTrials.gov: NCT03534284). SETTING: 26 dialysis units in Albuquerque, New Mexico, and Seattle, Washington. PARTICIPANTS: Patients with Insomnia Severity Index (ISI) score of 10 or greater, with sleep disturbances on 3 or more nights per week for 3 or more months. INTERVENTION: Participants were randomly assigned to 6 weeks of CBT-I, trazodone, or placebo. MEASUREMENTS: The primary outcome was the ISI score at 7 and 25 weeks from randomization. RESULTS: A total of 923 patients were prescreened, and of the 411 patients with chronic insomnia, 126 were randomly assigned to CBT-I (n = 43), trazodone (n = 42), or placebo (n = 41). The change in ISI scores from baseline to 7 weeks with CBT-I or trazodone was no different from placebo: CBT-I, -3.7 (95% CI, -5.5 to -1.9); trazodone, -4.2 (CI, -5.9 to -2.4); and placebo, -3.1 (CI, -4.9 to -1.3). There was no meaningful change in ISI scores from baseline to 25 weeks: CBT-I, -4.8 (CI, -7.0 to -2.7); trazodone, -4.0 (CI, -6.0 to -1.9); and placebo, -4.3 (CI, -6.4 to -2.2). Serious adverse events (SAEs), particularly serious cardiovascular events, were more frequent with trazodone (annualized cardiovascular SAE incidence rates: CBT-I, 0.05 [CI, 0.00 to 0.29]; trazodone, 0.64 [CI, 0.34 to 1.10]; and placebo, 0.21 [CI, 0.06 to 0.53]). LIMITATION: Modest sample size and most participants had mild or moderate insomnia. CONCLUSION: In patients undergoing hemodialysis with mild or moderate chronic insomnia, there was no difference in the effectiveness of 6 weeks of CBT-I or trazodone compared with placebo. The incidence of SAEs was higher with trazodone. PRIMARY FUNDING SOURCE: National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases.

Understanding resilience: Lifestyle-based behavioral predictors of mental health and well-being in community-dwelling older adults during the COVID-19 pandemic.

BACKGROUND: Changes in sleep, physical activity and mental health were observed in older adults during early stages of the COVID-19 pandemic. Here we describe effects of the COVID-19 pandemic on older adult mental health, wellbeing, and lifestyle behaviors and explore predictors of better mid-pandemic mental health and wellbeing. METHODS: Participants in the Adult Changes in Thought study completed measures of lifestyle behaviors (e.g., sleep, physical activity) and mental health and wellbeing both pre-pandemic during regular study visits and mid-pandemic via a one-time survey. We used paired t-tests to compare differences in these measures pre- vs. mid-pandemic. Using multivariate linear regression, we further explored demographic, health, and lifestyle predictors of pandemic depressive symptoms, social support, and fatigue. We additionally qualitatively coded free text data from the mid-pandemic survey for related comments. RESULTS: Participants (N = 896) reported significant changes in mental health and lifestyle behaviors at pre-pandemic vs. mid-pandemic measurements (p < 0.0001). Qualitative findings supported these behavioral and wellbeing changes. Being male, never smoking, and lower pre-pandemic computer time and sleep disturbance were significantly associated with lower pandemic depressive symptoms. Being partnered, female, never smoking, and lower pre-pandemic sleep disturbance were associated with higher pandemic social support. Pre-pandemic employment, more walking, less computer time, and less sleep disturbance were associated with less pandemic fatigue. Participant comments supported these quantitative findings, highlighting gender differences in pandemic mental health, changes in computer usage and physical activity during the pandemic, the value of spousal social support, and links between sleep disturbance and mental health and wellbeing. Qualitative findings also revealed additional factors, such as stresses from personal and family health situations and the country's concurrent political environment, that impacted mental health and wellbeing. CONCLUSIONS: Several demographic, health, and lifestyle behaviors appeared to buffer the effects of the COVID-19 pandemic and may be key sources of resilience. Interventions and public health measures targeting men and unpartnered individuals could promote social support resilience, and intervening on modifiable behaviors like sleep quality, physical activity and sedentary activities like computer time may promote resilience to fatigue and depressive symptoms during future community stressor events. Further research into these relationships is warranted.

The feasibility of a sleep education program for informal dementia care dyads: A pilot randomized controlled trial.

BACKGROUND: Untreated sleep problems in both persons living with dementia (PLWD) and their family care partners (CP) impact their health and quality of life. This pilot study tested a sleep intervention program for both dyad members. METHODS: Thirty dyads were randomized to a 5-session Care2Sleep intervention (n = 15 dyads) or an information-only control group (n = 15 dyads) delivered in-person or by video-telehealth by trained sleep educators. Care2Sleep is a manual-based program, incorporating key components of cognitive behavioral therapy for insomnia, daily light exposure and walking, and problem-solving for dementia-related behaviors. Adherence with Care2Sleep recommendations was assessed. Sleep outcomes included actigraphy-measured sleep efficiency (SE) and total wake time (TWT) for dyads, and the Pittsburgh Sleep Quality Index (PSQI) for CP. Other outcomes for CP included the Zarit Burden Interview (ZBI) and positive aspects of caregiving (PAC). Outcomes were measured at baseline, posttreatment, and 3-month follow-up. A 2 (group) by 3 (time) mixed model analysis of variance tested treatment effects. RESULTS: Study feasibility was demonstrated, with 13 dyads completing all five sessions of Care2Sleep program and 14 completing the control condition. In the Care2Sleep group, the dyads adhered to recommended sleep schedules of 76% for bedtime and 72% for get-up time for PLWD, and 69% for bedtime and 67% for get-up time for CP. There were several nonsignificant trends in outcomes from baseline to 3-month follow-up between the two groups. For example, SE increased by 3.2% more for PLWD and 3.2% more for CP with Care2Sleep versus control. TWT decreased by 14 min more for PLWD and 12 min more for CP with Care2Sleep versus control at the 3-month follow-up. CP in Care2Sleep also showed improvement in the PSQI, ZBI, and PAC scores. CONCLUSIONS: A dyadic approach to sleep improvement is feasible. Larger trials are needed to test effects of this intervention for PLWD and their family CP. CLINICALTRIALS: gov: NCT03455569.

Historic Cognitive Function Trajectories as Predictors of Sedentary Behavior and Physical Activity in Older Adults.

BACKGROUND: We examined whether trajectories of cognitive function over 10 years predict later-life physical activity (PA), sedentary time (ST), and sleep. METHODS: Participants were from the Adult Changes in Thought (ACT) cohort study. We included 611 ACT participants who wore accelerometers and had 3+ measures of cognition in the 10 years prior to accelerometer wear. The Cognitive Assessment Screening Instrument (CASI) measured cognition and was scored using item-response theory (IRT). activPAL and ActiGraph accelerometers worn over 7 days measured ST and PA outcomes. Self-reported time in bed and sleep quality measured sleep outcomes. Analyses used growth mixture modeling to classify CASI-IRT scores into latent groups and examine associations with PA, ST, and sleep including demographic and health covariates. RESULTS: Participants (Mean age = 80.3 (6.5) years, 90.3% White, 57.1% female, 29.3% had less than 16 years of education) fell into 3 latent trajectory groups: average stable CASI (56.1%), high stable CASI (34.0%), and declining CASI (9.8%). The declining group had 16 minutes less stepping time (95% confidence interval [95% CI]: 0.6, 31.4), 1 517 fewer steps per day (95% CI: 138, 2 896), and 16.3 minutes per day less moderate-to-vigorous PA (95% CI: 1.3, 31.3) compared to the average stable group. There were no associations between CASI trajectory and sedentary or sleep outcomes. CONCLUSIONS: Declining cognition predicted lower PA providing some evidence of a reverse relationship between PA and cognition in older adults. However, this conclusion is limited by having outcomes at only one time point, a nonrepresentative sample, self-reported sleep outcomes, and using a global cognition measure.

Poor sleep and inflammatory gene expression among care partners of persons living with dementia: a pilot trial of a behavioral sleep intervention.

Objective: Poor sleep is associated with increased inflammation, thereby increasing the risk of chronic diseases and mortality. However, the effects of behavioral sleep interventions on the upstream inflammatory system are unknown among family care partners (CP). The present study explored the role of a behavioral sleep intervention program on inflammatory gene expression. Methods: This was part of a randomized controlled trial of a sleep intervention for dementia care dyads with sleep problems. Thirty dyads were randomized to sleep intervention or control groups. Sleep outcomes for CP were assessed with 1 week of actigraphy and sleep diary, and the Pittsburgh Sleep Quality Index. Other information included CP demographics, body mass index, and intensity of caregiving tasks. All outcomes were collected at baseline, post-treatment, and 3-month follow-up. Results: Neither group showed any significant differential changes in gene expression from baseline to post-treatment or 3-month follow-up. A decrease in inflammatory gene expression was significantly associated with more nights of good sleep (i.e. nights without trouble falling or staying asleep at night). This finding remained significant after controlling for group (intervention/control), timepoint (baseline, post-treatment, and 3-month follow-up), and CP characteristics (e.g. age and ethnicity). Conclusions: Although better sleep was associated with decreased inflammatory gene expression, this study did not demonstrate any benefits of a behavioral sleep intervention over control, most likely due to a small sample. Studies with larger sample sizes are needed to test the specific aspects of disturbed sleep that relate to inflammatory biology among CP of persons living with dementia.