title: Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial.
abstract: OBJECTIVE
  Effective, practical, nonpharmacologic therapies are needed to treat menopause-related insomnia symptoms in primary and women's specialty care settings.
  
  
  OBJECTIVE
  To evaluate the efficacy of telephone-based cognitive behavioral therapy for insomnia (CBT-I) vs menopause education control (MEC).
  
  
  METHODS
  A single-site, randomized clinical trial was conducted from September 1, 2013, to August 31, 2015, in western Washington State among 106 perimenopausal or postmenopausal women aged 40 to 65 years with moderate insomnia symptoms (Insomnia Severity Index [ISI] score, ≥12) and 2 or more daily hot flashes. Blinded assessments were conducted at baseline, 8, and 24 weeks postrandomization. An intent-to-treat analysis was conducted.
  
  
  METHODS
  Six CBT-I or MEC telephone sessions in 8 weeks. Participants submitted weekly electronic sleep diaries and received group-specific written educational materials. The CBT-I sessions included sleep restriction, stimulus control, sleep hygiene education, cognitive restructuring, and behavioral homework; MEC sessions provided information about menopause and women's health.
  
  
  METHODS
  Primary outcome was scores on the ISI (score range, 0-28; scores ≥15 indicate moderate to severe insomnia). Secondary outcome was scores on the Pittsburgh Sleep Quality Index (score range, 0-21; higher scores indicate worse sleep quality). Additional outcomes included sleep and hot flash diary variables and hot flash interference.
  
  
  RESULTS
  At 8 weeks, ISI scores had decreased 9.9 points among 53 women receiving CBT-I (mean [SD] age, 55.0 [3.5] years) and 4.7 points among 53 women receiving MEC (age, 54.7 [4.7] years), a mean between-group difference of 5.2 points (95% CI, -6.1 to -3.3; P < .001). Pittsburgh Sleep Quality Index scores decreased 4.0 points in women receiving CBT-I and 1.4 points in women receiving MEC, a mean between-group difference of 2.7 points (95% CI, -3.9 to -1.5; P < .001). Significant group differences were sustained at 24 weeks. At 8 and 24 weeks, 33 of 47 women (70%) and 37 of 44 (84%) in the CBT-I group, respectively, had ISI scores in the no-insomnia range compared with 10 of 41 (24%) and 16 of 37 (43%) in the MEC group, respectively. The CBT-I group also had greater improvements in diary-reported sleep latency, wake time, and sleep efficiency. There were no between-group differences in frequency of daily hot flashes, but hot flash interference was significantly decreased at 8 weeks for the CBT-I group (-15.7; 95% CI, -20.4 to -11.0) compared with the MEC group (-7.1; 95% CI, -14.6 to 0.4) (P = .03), differences that were maintained at 24 weeks for the CBT-I group (-22.8; 95% CI, -28.6 to -16.9) and MEC group (-11.6; 95% CI, -19.4 to -3.8) (P = .003).
  
  
  CONCLUSIONS
  Telephone-based CBT-I improved sleep in perimenopausal and postmenopausal women with insomnia and hot flashes. Results support further development and testing of centralized CBT-I programs for treating menopausal insomnia.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01936441.
authors.affiliation: Department of Psychosocial and Community Health, University of Washington, Seattle.
authors.forename: Susan M
authors.initials: SM
authors.lastname: McCurry
authors.affiliation: Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Katherine A
authors.initials: KA
authors.lastname: Guthrie
authors.affiliation: Department of Psychology, Université Laval, Quebec City, Quebec, Canada.
authors.forename: Charles M
authors.initials: CM
authors.lastname: Morin
authors.affiliation: Biobehavioral Nursing and Health Systems, University of Washington, Seattle.
authors.forename: Nancy F
authors.initials: NF
authors.lastname: Woods
authors.affiliation: Biobehavioral Nursing and Health Systems, University of Washington, Seattle.
authors.forename: Carol A
authors.initials: CA
authors.lastname: Landis
authors.affiliation: Division of Epidemiology and Community Health, Department of Medicine, University of Minnesota, Minneapolis6Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.
authors.forename: Kristine E
authors.initials: KE
authors.lastname: Ensrud
authors.affiliation: Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Larson
authors.affiliation: Division of Women's Mental Health, Department of Psychiatry, Brigham & Women's Hospital and Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.
authors.forename: Hadine
authors.initials: H
authors.lastname: Joffe
authors.affiliation: Department of Psychiatry, Center for Women's Mental Health, Massachusetts General Hospital, Harvard Medical School, Boston.
authors.forename: Lee S
authors.initials: LS
authors.lastname: Cohen
authors.affiliation: Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Julie R
authors.initials: JR
authors.lastname: Hunt
authors.affiliation: Group Health Research Institute, Group Health Cooperative, Seattle, Washington.
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Newton
authors.affiliation: Department of Science of Nursing Care, Indiana University, Indianapolis.
authors.forename: Julie L
authors.initials: JL
authors.lastname: Otte
authors.affiliation: Department of Obstetrics and Gynecology, University of Washington, Seattle.
authors.forename: Susan D
authors.initials: SD
authors.lastname: Reed
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland.
authors.forename: Barbara
authors.initials: B
authors.lastname: Sternfeld
authors.affiliation: Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Lesley F
authors.initials: LF
authors.lastname: Tinker
authors.affiliation: Department of Family Medicine and Public Health, University of California-San Diego, La Jolla.
authors.forename: Andrea Z
authors.initials: AZ
authors.lastname: LaCroix
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000295:instrumentation / Q000379:methods; D005260:Female; D006801:Humans; D007406:Interview, Psychological / Q000379:methods*; D008875:Middle Aged; D063868:Patient Outcome Assessment; D047648:Perimenopause / Q000502:physiology / Q000523:psychology; D017698:Postmenopause / Q000502:physiology / Q000523:psychology; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis / Q000209:etiology / Q000523:psychology / Q000628:therapy; D013664:Teaching Materials; D013689:Telephone