title: Improved sleep quality in older adults with insomnia reduces biomarkers of disease risk: pilot results from a randomized controlled comparative efficacy trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Randomized controlled comparative efficacy trial.
  
  
  METHODS
  Los Angeles community.
  
  
  METHODS
  A population-based sample of 109 older adults with chronic and primary insomnia.
  
  
  METHODS
  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).
  
  
  METHODS
  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
  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 name—ClinicalTrials.gov: NCT00280020, Behavioral Treatment of Insomnia in Aging
authors.affiliation: University of California, Los Angeles-Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA; University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, Los Angeles, CA, USA. Electronic address: jcarroll@mednet.ucla.edu.
authors.forename: Judith E
authors.initials: JE
authors.lastname: Carroll
authors.affiliation: University of California, Los Angeles, Division of Geriatrics, David Geffen School of Medicine, Los Angeles, CA, USA.
authors.forename: Teresa E
authors.initials: TE
authors.lastname: Seeman
authors.affiliation: University of California, Los Angeles-Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA; University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, Los Angeles, CA, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Olmstead
authors.affiliation: University of California, Los Angeles-Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA; University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, Los Angeles, CA, USA.
authors.forename: Gerson
authors.initials: G
authors.lastname: Melendez
authors.affiliation: University of California, Los Angeles-Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA; University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, Los Angeles, CA, USA.
authors.forename: Ryan
authors.initials: R
authors.lastname: Sadakane
authors.affiliation: University of Arizona, Department of Psychology, Tucson, AZ, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Bootzin
authors.affiliation: University of California, Los Angeles-Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA.
authors.forename: Perry
authors.initials: P
authors.lastname: Nicassio
authors.affiliation: University of California, Los Angeles-Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA; University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, Los Angeles, CA, USA. Electronic address: mirwin1@ucla.edu.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Irwin
mesh_terms: D000368:Aged; D052636:Allostasis; D015415:Biomarkers / Q000378:metabolism*; D001786:Blood Glucose / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000378:metabolism*; D008076:Cholesterol, HDL / Q000378:metabolism; D008078:Cholesterol, LDL / Q000378:metabolism; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003920:Diabetes Mellitus / Q000378:metabolism*; D005260:Female; D005340:Fibrinogen / Q000378:metabolism; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007328:Insulin / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods; D010865:Pilot Projects; D007319:Sleep Initiation and Maintenance Disorders / Q000378:metabolism / Q000628:therapy*; D026302:Tai Ji / Q000379:methods*; D016896:Treatment Outcome; D014280:Triglycerides / Q000378:metabolism
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D002097:C-Reactive Protein; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D005340:Fibrinogen; D006442:Glycated Hemoglobin; D007328:Insulin; D014280:Triglycerides; C517652:hemoglobin A1c protein, human
keywords: Allostatic load; ClinicalTrials.gov: NCT00280020, Behavioral Treatment of Insomnia in Aging; Disease risk; Insomnia; Intervention; Multisystem; Sleep