Development and Validity of the Japanese Version of the Pre-Sleep Arousal Scale.

Hyperarousal, defined as increased levels of cortical activity and cognitive-emotional reactivity induced by stress, is suggested to be a key factor in insomnia. In particularly, pre-sleep arousal constitutes one of the major features of insomnia. The Pre-Sleep Arousal Scale is the best-known measure used to evaluate pre-sleep arousal. However, a well-validated Japanese version of the scale (PSAS-J) has not yet been established. The aim of this research was to develop and validate such a scale. A cross-sectional questionnaire-based study was conducted via the internet. In total, 237 of 300 participants (mean age 43.28 ± 11.19 years) completely responded to the questionnaires as followed: the PSAS-J, the Insomnia Severity Index, Ford Insomnia Response to Stress Test, and Dysfunctional Beliefs and Attitudes about Sleep Scale. In addition, the participants were divided into two groups: insomniacs and normal sleepers. As a result, the PSAS-J had a two-factor structure similar to that of the original version, i.e., somatic and cognitive arousal subscales. The internal consistency (α = 0.85 to 0.90) and test-retest reliability (r = 0.67 to 0.78) were high. Correlations between the PSAS-J and the above-mentioned scales ranged from 0.35 to 0.53. Discriminant validity showed that the PSAS-J was distinct from the Ford Insomnia Response to Stress Test and Dysfunctional Beliefs and Attitudes about Sleep Scale. The PSAS-J scores were significantly higher in insomniacs than in normal sleepers. Our results suggest that the PSAS-J has high reliability and validity and that this scale is adequate for assessing pre-sleep arousal.

Psychological Factors that Link Socioeconomic Status to Depression/Anxiety in Patients with Systemic Lupus Erythematosus.

Our analyses examined whether reserve capacity factors would explain the relationship between socioeconomic status (SES) and symptoms of depression/anxiety in patients with systemic lupus erythematosus (SLE). We assessed disease activity, depression/anxiety symptoms, and intrapersonal and interpersonal reserve capacity measures in 128 patients with SLE. Multiple meditational analyses revealed that intrapersonal and interpersonal psychosocial aspects of reserve capacity fully mediated the relationship between SES and depression/anxiety. Lower SES was indirectly associated with higher symptoms of depression and anxiety through the effects of psychosocial resilience. Interventions aimed at improving modifiable reserve capacity variables, such as self-esteem and optimism, may improve anxious/depressive symptomatology in patients with SLE.

Confirmatory factor analysis of the Pittsburgh Sleep Quality Index in rheumatoid arthritis patients.

The purpose of this research was to evaluate the factor structure of the Pittsburgh Sleep Quality Index (PSQI) in rheumatoid arthritis (RA). The sample included 107 patients with RA, 88 females and seven males, with an average age of 56.09 years, recruited from the greater Southern California area. Confirmatory factor analysis evaluated single, two- and three-factor models. The single factor solution yielded a poor fit to the data. While the three-factor solution had the best fit, the two-factor solution, comprised of sleep efficiency and perceived sleep quality factors, was optimal because it had very good fit, and acceptable reliability for its individual factors. Clinical indices were consistently correlated with the sleep quality factor, but not with the sleep efficiency factor.

The psychometric properties of the Turkish version of the Pre-sleep Arousal Scale.

Purpose: The aim of the present study was to examine the psychometric properties of the Turkish version of the Pre-sleep Arousal Scale (PSAS), which measures pre-sleep arousal, a significant predictor of insomnia symptoms. Methods: 651 participants were recruited via social media and the Internet. Confirmatory factor analysis was conducted in the total sample (65.28% females; Mage1 = 28.09 ± 14.00). Convergent, divergent, incremental, and known-groups validity and internal consistency coefficients were assessed in a subsample of 556 participants (62.77% females; Mage2 = 29.25 ± 14.81). A second separate sample of 88 participants (80.68% females; Mage3 = 22.19 ± 4.98) was used to evaluate three-week test-retest reliability. Results: The results of factor analysis confirmed the two-factor structure of the Turkish PSAS with cognitive (PSAS-C) and somatic (PSAS-S), similar to the original scale. The correlations of the PSAS with convergent and divergent measures showed that the Turkish form had good convergent and acceptable divergent validity. PSAS-C and PSAS-S were able to explain an 18% additional variance in insomnia severity beyond depression and anxiety, an 18% additional variance in depression beyond insomnia severity, and a 35% additional variance in anxiety beyond insomnia severity. Moreover, insomnia patients had significantly higher PSAS-C and PSAS-S scores than good sleepers. Finally, the PSAS, PSAS-C, and PSAS-S had satisfactory internal consistency coefficients (α = 0.92, 0.91, and 0.86, respectively) and three-week test-retest correlations (ICC = 0.82, 0.82, and 0.71, respectively). Conclusion: The Turkish form of the PSAS was a valid and reliable measure of pre-sleep arousal and can be utilized in sleep studies. Supplementary Information: The online version contains supplementary material available at 10.1007/s41105-023-00483-z.

Socioeconomic status, reserve capacity, and depressive symptoms predict pain in Rheumatoid Arthritis: an examination of the reserve capacity model.

BACKGROUND: Guided by the reserve capacity model, we evaluated the unique relationships between socioeconomic status (SES), reserve capacity (helplessness, self-efficacy, social support), and negative emotions on pain in patients with Rheumatoid Arthritis (RA). METHODS: The secondary analysis used baseline, cross-sectional data from 106 adults in a clinical trial comparing behavioral treatments for RA. Patients were eligible if they were ≥ 18 years old, met the ACR criteria for RA (determined by study rheumatologist), had stable disease and drug regimens for 3 months, and did not have a significant comorbid condition. Structural equation modeling evaluated the direct effects of SES, reserve capacity (helplessness- Arthritis Helplessness Index, self-efficacy -Personal Mastery Scale, social support- Social Provisions Scale) and negative emotions (stress and depressive symptoms- Perceived Stress Scale and Hamilton Depression Rating Scale) on pain (Rapid Assessment of Disease Activity in Rheumatology-RADAR & visual analog scale-VAS), and the indirect effects of SES as mediated by reserve capacity and negative emotions. The SEM model was evaluated using multiple fit criteria: χ2 goodness-of-fit statistic, the comparative fit index (CFI), the standardized root mean square residual (SRMR), and the root mean square error of approximation (RMSEA). RESULTS: Participants were mostly female (85%), 55.45 years old on average, self-identified as white (61%), Hispanic (16%), black (13%), and other (10%), and had RA for an average of 10.63 years. Results showed that low SES contributed to worse pain, through lower reserve capacity and higher negative emotions. Mediational analyses showed that reserve capacity and negative emotions partially mediated the effect of SES on pain. The final model explained 39% of the variance in pain. CONCLUSIONS: The findings indicate that lower SES was related to worse clinical pain outcomes and negative emotions and reserve capacity (helplessness, social support, and self-efficacy) mediated the effect of SES on pain. A primary limitation is the small sample size; future studies should evaluate this model further in larger, longitudinal approaches. Interventions that target negative emotions in patients with low SES may facilitate better pain control with RA. TRIAL REGISTRATION: clinicaltrials.gov NCT00072657 01/02/2004 20/03/2009.

Socioeconomic Status, Reserve Capacity, and Depressive Symptoms Predict Pain in Rheumatoid Arthritis: An Examination of the Reserve Capacity Model.

Background: Guided by the reserve capacity model, we examined the roles of socioeconomic status (SES), reserve capacity, and negative emotions as determinants of pain in patients with Rheumatoid Arthritis (RA). Methods: The study used cross-sectional baseline data from 106 adults in a clinical trial comparing behavioral treatments for RA. Structural equation modeling evaluated the direct effects of SES, reserve capacity (helplessness, self-efficacy, social support) and negative emotions (stress and depressive symptoms) on pain, and the indirect effects of SES as mediated by reserve capacity and negative emotions. Results: Results showed that low SES contributed to greater pain, through lower reserve capacity and higher negative emotions. Mediational analyses showed that reserve capacity and negative emotions partially mediated the effect of SES on pain. Conclusions: The findings indicate that interventions that target negative emotions in patients with low SES may facilitate better pain control with RA. Trial registration: clinicaltrials.gov NCT00072657; 02/2004.

The contribution of disease activity on functional limitations over time through psychological mediators: a 12-month longitudinal study in patients with ankylosing spondylitis.

OBJECTIVES: To explore whether helplessness, internality and depression would mediate the relationship between disease activity and functional limitations in patients with AS in a 12-month longitudinal study. METHODS: A total of 294 participants with AS meeting modified New York criteria completed clinical and psychological assessments at 6-month intervals. Psychological measures evaluated helplessness, depression and internality. Path analysis evaluated the direct and indirect effects of baseline disease activity on 12-month functional limitations via the psychological measures of helplessness, internality and depression at 6 months. RESULTS: Baseline disease activity demonstrated direct and indirect effects on 12-month functional limitations. Helplessness and depression, but not internality, served as mediators of the relationship between disease activity and functional limitations. CONCLUSION: Higher baseline disease activity predicted greater functional limitations at 12 months through helplessness and depression. Our findings suggest that helplessness and depression may constitute future treatment targets in reducing functional limitations in patients with AS.

Nonpharmacologic Pain Management in Inflammatory Arthritis.

This article provides an overview of nonpharmacologic options for the treatment of pain in patients with inflammatory arthritis, such as peripheral spondyloarthritis, psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis. The experience of pain in chronic disease is a complex process influenced by multiple domains of health. The discussion focuses on the establishment of a framework for pain control that engages with factors that influence the experience of pain and explores the evidence base that supports specific modalities of nonpharmacologic pain control, such as mindfulness, cognitive behavioral therapy, exercise, massage, splinting, and heat therapy. Rheumatoid and spondyloarthritides are considered separately.

The contributions of socioeconomic status, perceived stress, and depression to disability in adults with systemic lupus erythematosus.

Purpose: Psychological and sociodemographic factors contribute to disability in systemic lupus erythematosus. Yet the pathways by which these factors influence disability remain unclear. The objective of this study was to evaluate a model examining socioeconomic status (SES), perceived stress, and depressive symptoms as determinants of lupus-related disability.Methods: The sample included 134 patients receiving treatment at an academic hospital. Structural equation modeling examined the direct and indirect effects of SES (income, education, and subjective social status), perceived stress (Perceived Stress Scale), and depressive symptoms (Hospital Depression Anxiety Scale depression subscale) on disability (Lupus Patient-Reported Outcome measure Physical Health and Pain-Vitality subscales).Results: Structural equation modeling confirmed that the model fit the data well. The SES exerted a direct negative effect on perceived stress (ß = -0.40, p < 0.001). In turn, perceived stress predicted higher levels of depression (ß = 0.72, p < 0.001), which ultimately contributed to greater disability (ß = 0.53, p < 0.001). The influence of SES on disability was indirect (mediated by perceived stress and depression).Conclusions: Findings support the socioeconomic gradient in disability as mediated by perceived stress and depression, such that lower SES contributed to lupus-related disability via perceived stress and depressive symptoms.Implications for RehabilitationLow socioeconomic status, perceived stress, and depression are prognostic factors for the disability in systemic lupus erythematosus.Study findings indicate that perceived stress and depression fully mediate (account for) the negative impact of low socioeconomic status on lupus-related disability.Screening for and addressing psychological distress may enhance management of disability in lupus patients.This research demonstrates the value of a conceptual framework for identifying potentially modifiable risk factors for disability in lupus and other chronic disabling diseases.

Perceived Stress and Inflammatory Arthritis: A Prospective Investigation in the Studies of the Etiologies of Rheumatoid Arthritis Cohort.

OBJECTIVE: The aim of this study was to determine the association of perceived stress with incident inflammatory arthritis (IA) defined as having at least 1 joint consistent with rheumatoid arthritis (RA)-like synovitis based on examination. METHODS: We conducted a prospective cohort study in the Studies of the Etiologies of Rheumatoid Arthritis cohort. Participants without IA were recruited if they were a first-degree relative of an RA proband or screened positive for anti-citrullinated protein antibody. Perceived stress was measured using the Perceived Stress Scale-14 (PSS-14), in which scores can range from 0 to 56, and a higher score indicates greater perceived stress. The total PSS-14 score, as well as 2 subscores indicative of perceived distress and self-efficacy, were averaged across all study visits until development of IA or the last follow-up. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) of IA associated with average PSS-14 scores were obtained using Cox proportional hazards models. RESULTS: The mean total PSS-14 score was 20.4. We found that a 1-point increase in the perceived distress score was significantly associated with a 10-percent increase in the risk of IA (adjusted HR 1.10 [95% CI 1.02-1.19]). Total PSS-14 and self-efficacy were not associated with IA risk (adjusted HR 1.05 [95% CI 0.99-1.10] and 1.04 [95% CI 0.91-1.18], respectively). CONCLUSION: An association between perceived distress and incident IA was observed in this at-risk cohort. Replication of this finding in other preclinical and at-risk RA populations is needed.

Pre-Sleep Arousal Scale (PSAS): psychometric study of a European Portuguese version.

OBJECTIVE/BACKGROUND: Pre-sleep arousal constitutes one of the major features of insomnia. As such, it is imperative to have adequate instruments to measure this construct in both clinical and research settings. The Pre-Sleep Arousal Scale (PSAS) is the most well-known measure to evaluate pre-sleep arousal. The current study aimed to examine some of the psychometric properties of a European Portuguese version of the scale. PARTICIPANTS/METHODS: For this purpose, data from 691 undergraduate students from a medical school were analyzed. Internal consistency indices and factor analysis were performed. In addition, the association between the PSAS and its subscales with other measures was also examined. Finally, PSAS scores of self-reported insomniacs were compared with those of self-reported non-insomniacs. RESULTS: The results indicated that the PSAS comprises a cognitive scale and a somatic scale, both with adequate internal consistency indices (α = 0.82 and 0.79, respectively). However, a three-factor solution also seemed plausible, suggesting that the original somatic arousal subscale might be divided into two subscales. Significant associations between the PSAS total score and its subscales were found with other concurrent measures such as sleep reactivity to stress, arousability and neuroticism. Self-defined insomniacs presented higher levels of cognitive and somatic arousal than healthy individuals. CONCLUSIONS: Further investigations of the PSAS are needed to refine its psychometric properties and explore its research and clinical utility in other populations.

Role of psychosocial reserve capacity in anxiety and depression in patients with systemic lupus erythematosus.

AIM: To examine the relationship between reserve capacity measures and anxiety/depression among patients with systemic lupus erythematosus (SLE) from Southern California (SoCal), United States and Manila, Philippines. METHODS: A total of 235 participants with SLE completed self-reported scales to assess anxiety/depression and psychosocial reserve capacity measures (self-esteem, optimism, personal mastery/coping skills, social support), socioeconomic status (SES) data, and Mexican SLE Disease Activity Index. Statistical analyses included independent sample t-tests, Chi-square, and point-biserial and Pearson correlations. RESULTS: Overall, participants from Manila reported lower SES than SoCal participants. Over half of Manila and SoCal participants (69% and 59.1%, respectively) reported high anxiety scores. SoCal participants had higher depression scores than Filipinos (66%, 27%, respectively, P < 0.001) despite appearing to be more resilient by exhibiting higher scores for all reserve capacity measures (P < 0.001). Participants with low self-esteem scores from both groups had higher anxiety and depression scores. SoCal participants who reported lower optimism, lower personal mastery and lower social support were more anxious and depressed, while Filipinos low on these three variables reported less depressive symptoms. CONCLUSION: Reduced psychosocial reserve capacity in individuals leads to vulnerabilities that may ultimately result in greater disease burden and psychological distress. Low self-esteem, optimism, coping and social support were associated with depression and low self-esteem was associated with anxiety for both groups. Despite the Filipino cohort's lower reserve capacity and SES, Filipino patients exhibited less depression than their SoCal counterparts, suggesting that other factors may protect them from experiencing depression.

Tai Chi Chih Compared With Cognitive Behavioral Therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A Randomized, Partially Blinded, Noninferiority Trial.

Purpose Cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC), a movement meditation, improve insomnia symptoms. Here, we evaluated whether TCC is noninferior to CBT-I for the treatment of insomnia in survivors of breast cancer. Patients and Methods This was a randomized, partially blinded, noninferiority trial that involved survivors of breast cancer with insomnia who were recruited from the Los Angeles community from April 2008 to July 2012. After a 2-month phase-in period with repeated baseline assessment, participants were randomly assigned to 3 months of CBT-I or TCC and evaluated at months 2, 3 (post-treatment), 6, and 15 (follow-up). Primary outcome was insomnia treatment response-that is, marked clinical improvement of symptoms by the Pittsburgh Sleep Quality Index-at 15 months. Secondary outcomes were clinician-assessed remission of insomnia; sleep quality; total sleep time, sleep onset latency, sleep efficiency, and awake after sleep onset, derived from sleep diaries; polysomnography; and symptoms of fatigue, sleepiness, and depression. Results Of 145 participants who were screened, 90 were randomly assigned (CBT-I: n = 45; TCC: n = 45). The proportion of participants who showed insomnia treatment response at 15 months was 43.7% and 46.7% in CBT-I and TCC, respectively. Tests of noninferiority showed that TCC was noninferior to CBT-I at 15 months ( P = .02) and at months 3 ( P = .02) and 6 ( P < .01). For secondary outcomes, insomnia remission was 46.2% and 37.9% in CBT-I and TCC, respectively. CBT-I and TCC groups showed robust improvements in sleep quality, sleep diary measures, and related symptoms (all P < .01), but not polysomnography, with similar improvements in both groups. Conclusion CBT-I and TCC produce clinically meaningful improvements in insomnia. TCC, a mindful movement meditation, was found to be statistically noninferior to CBT-I, the gold standard for behavioral treatment of insomnia.

Trends in Functional Disability and Determinants of Clinically Meaningful Change Over Time in Hispanic Patients With Rheumatoid Arthritis in the US.

OBJECTIVE: To identify determinants of clinically meaningful change in functional disability in low-income Hispanic patients with established rheumatoid arthritis (RA) in the US. METHODS: We evaluated 156 low-socioeconomic status, uninsured, largely immigrant Hispanic patients, collectively described as vulnerable patients, on 3 consecutive visits (baseline, 6, and 12 months followup) at a single center. Disability (Health Assessment Questionnaire [HAQ] disability index [DI]), pain (visual analog scale), and depression (Patient Health Questionnaire [PHQ-9]) were assessed each time. Disease activity (Disease Activity Score in 28 joints [DAS28] using the erythrocyte sedimentation rate), serology results, radiographs, treatments, and irreversible articular damage were also recorded. RESULTS: At baseline, 71% had significant disability (HAQ DI >1), and 34% were depressed. HAQ DI improved significantly over time (P = 0.032), and absence of depression (PHQ-9 <10), lower pain, lack of erosions, and no biologic agent use at baseline all predicted the greatest improvement (P < 0.001). Baseline to 12-month HAQ DI recovery exceeding the minimum clinically important difference (MCID) occurred in 42% of patients. Recovery was associated with concurrent improvements in DAS28, pain, and PHQ-9 scores (albeit below their respective MCIDs), as well as with absence of erosions. Notably, isolated shifts in PHQ-9 or pain scores over MCID were sufficient to yield clinically meaningful HAQ DI changes. CONCLUSION: Results suggest that disease activity, depression, and pain are modifiable parameters with consistent, significant, independent, and additive contributions to HAQ DI changes across the disease trajectory in vulnerable Hispanic patients with RA. Their improvement over time, collectively or in isolation, may yield clinically measurable improvements in functional disability and reaffirms these parameters as actionable items in a patient-centered treat-to-target approach.

Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age.

Meta-analyses support the effectiveness of behavioral interventions for the treatment of insomnia, although few have systematically evaluated the relative efficacy of different treatment modalities or the relation of old age to sleep outcomes. In this meta-analysis of randomized controlled trials (k = 23), moderate to large effects of behavioral treatments on subjective sleep outcomes were found. Evaluation of the moderating effects of behavioral intervention type (i.e., cognitive-behavioral treatment, relaxation, behavioral only) revealed similar effects for the 3 treatment modalities. Both middle-aged adults and persons older than 55 years of age showed similar robust improvements in sleep quality, sleep latency, and wakening after sleep onset. A research agenda is recommended to examine the mechanisms of action of behavioral treatments on sleep with increased attention to the high prevalence of insomnia in older individuals.

Perspectives of vulnerable U.S Hispanics with rheumatoid arthritis on depression: awareness, barriers to disclosure, and treatment options.

OBJECTIVE: Despite the high prevalence of depression among vulnerable Hispanics with rheumatoid arthritis (RA), many do not disclose it or seek treatment. This study explored patient perceptions of depression, its association with their primary disease, barriers to disclosure, reasons for low utilization of mental health care resources, and culturally acceptable intervention approaches. METHODS: Semistructured interviews were conducted with 46 participants with RA. Depression was evaluated using Patient Health Questionnaire 9 (PHQ-9). RESULTS: Thirty-three percent of participants were moderately depressed at the time of the interview, based on PHQ-9 score ≥10; 12 of 46 patients (26%) stated they were depressed regardless of PHQ-9 score. Depression was perceived as a long-term, severe problem leading to suicide. It was associated with weakness and character flaws, contributing to stigma and reduced likelihood of disclosure. Antidepressants were not acceptable; self-reliance and interventions incorporating interpersonal connections were preferred. Systems-related barriers to disclosure included lack of verbal screening, language barriers, limited clinic visit time, and lack of continuity of care, restricting trust with providers. CONCLUSION: Rectifying misconceptions, as well as providing education regarding the association between RA and depression, the continuum of symptoms, and the range of experiences incurred are needed to facilitate earlier recognition and reduce stigma. Use, duration, and goals of antidepressant therapy should be clarified. Providers should strive to establish trust and conduct in-person depression screening to facilitate disclosure. Interventions with an interpersonal component, such as support groups or patient navigators, were preferred. Themes emphasizing coping strategies, stress reduction, positive thinking, self-efficacy, and resiliency are likely to be most acceptable.

Multidimensional Model of Disability and Role Functioning in Rheumatoid Arthritis.

OBJECTIVE: To examine a model addressing the roles of rheumatoid arthritis (RA) disease burden, mood disturbance, and disability as determinants of impairments in role functioning. METHODS: In a cross-sectional design, 103 RA patients recruited from the community to participate in a clinical trial completed assessments of self-assessed disease burden (total joint pain and disease activity), mood disturbance (Center for Epidemiological Studies Depression Scale depressed mood, somatic symptoms, lack of positive affect, and interpersonal problems), disability (Health Assessment Questionnaire disability index gross and fine motor), and role functioning (Short Form 36 health survey physical and social). Structural equation modeling (SEM) was used to examine direct and indirect mechanisms linking disease burden to role functioning. RESULTS: SEM results indicated that the model had excellent fit: S-Bχ(2)(30) = 38.59, P = 0.135; comparative fit index = 0.977, standardized root mean residual = 0.062, and root mean square error of approximation = 0.053. Mediational analyses demonstrated that, while disease burden was associated with poor role functioning, its effects were jointly mediated by mood disturbance and disability. After the effects of mood disturbance and disability were taken into account, the effect of disease burden on role functioning was not significant. CONCLUSION: The results indicate that mood disturbance and disability may serve as important pathways through which RA disease burden affects role functioning. Future longitudinal research is suggested to replicate these findings and further explore the mediational mechanisms examined in this study.

Cognitive behavioral therapy and tai chi reverse cellular and genomic markers of inflammation in late-life insomnia: a randomized controlled trial.

BACKGROUND: Sleep disturbance is associated with activation of systemic and cellular inflammation, as well as proinflammatory transcriptional profiles in circulating leukocytes. Whether treatments that target insomnia-related complaints might reverse these markers of inflammation in older adults with insomnia is not known. METHODS: In this randomized trial, 123 older adults with insomnia were randomly assigned to cognitive-behavioral therapy for insomnia (CBT-I), tai chi chih (TCC), or sleep seminar education active control condition for 2-hour sessions weekly over 4 months with follow-up at 7 and 16 months. We measured C-reactive protein (CRP) at baseline and months 4 and 16; toll-like receptor-4 activated monocyte production of proinflammatory cytokines at baseline and months 2, 4, 7, and 16; and genome-wide transcriptional profiling at baseline and month 4. RESULTS: As compared with sleep seminar education active control condition, CBT-I reduced levels of CRP (months 4 and 16, ps < .05), monocyte production of proinflammatory cytokines (month 2 only, p < .05), and proinflammatory gene expression (month 4, p < .01). TCC marginally reduced CRP (month 4, p = .06) and significantly reduced monocyte production of proinflammatory cytokines (months 2, 4, 7, and 16; all ps < .05) and proinflammatory gene expression (month 4, p < .001). In CBT-I and TCC, TELiS promoter-based bioinformatics analyses indicated reduced activity of nuclear factor-κB and AP-1. CONCLUSIONS: Among older adults with insomnia, CBT-I reduced systemic inflammation, TCC reduced cellular inflammatory responses, and both treatments reduced expression of genes encoding proinflammatory mediators. The findings provide an evidence-based molecular framework to understand the potential salutary effects of insomnia treatment on inflammation, with implications for inflammatory disease risk.

Improved sleep quality in older adults with insomnia reduces biomarkers of disease risk: pilot results from a randomized controlled comparative efficacy trial.

IMPORTANCE: Sleep disturbances have been linked to increased morbidity and mortality, yet it is unknown whether improving sleep quality in older adult patients with insomnia alters biomarkers of diabetes and cardiovascular disease risk. OBJECTIVE: Determine the comparative efficacy of cognitive behavioral therapy (CBT), tai chi chih (TCC), and a sleep seminar control (SS) to reduce multisystem biomarkers of disease risk in older adults with insomnia. DESIGN: Randomized controlled comparative efficacy trial. SETTING: Los Angeles community. PARTICIPANTS: A population-based sample of 109 older adults with chronic and primary insomnia. INTERVENTION: Random assignment to CBT, TCC, or SS for 2-h group sessions weekly over 4 months with a 16-month evaluation (1 year after follow-up). MAIN OUTCOME(S) AND MEASURE(S): Multisystem biological risk comprised of 8 biomarkers: high-density lipoprotein, low-density lipoprotein, triglycerides, hemoglobinA1c, glucose, insulin, C-reactive protein, and fibrinogen. Using clinical laboratory cutoffs defined as abnormal, a multisystem risk score was computed representing a sum of the deviation around the cutoffs across the 8 biomarkers. In addition, high risk grouping was classified if subjects exhibited 4 or more biomarkers in the abnormal laboratory range. RESULTS: An interaction of time-by-treatment-by-high risk group was found (F(4, 197.2)=3.14, p=.02) in which both TCC (p=.04) and CBT (p=.001) showed significantly lower risk scores as compared to SS at 16-months. CBT reduced risk of being in the high risk group at 4-months (odds ratio [OR]=.21 [95% CI, .03-1.47], p<.10) and at 16-months (OR=.06 [95% CI, .005-.669]; p<.01). TCC reduced the risk at 16-months (OR=.10 [95% CI, .008-1.29]; p<.05) but not at 4 months. Of participants who were classified in the high risk category at baseline, improvements in sleep quality, as defined by a clinical severity threshold, reduced the likelihood of being in the high risk group at 16-months, OR=.08 (95% CI, .008-.78); p=.01. CONCLUSIONS AND RELEVANCE: Participants classified as having high multisystem biological risk at entry and assigned to CBT or TCC show improvements in risk scores after one year follow-up. Given that these clinical biomarkers are associated with cardiovascular, metabolic, and inflammatory disease risk, improving sleep quality has the potential to reduce the risk of chronic disease in older adults with insomnia. Clinical Trial Registration # and name­ClinicalTrials.gov: NCT00280020, Behavioral Treatment of Insomnia in Aging