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Original Investigation
July 2016

Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor SymptomsA MsFLASH Randomized Clinical Trial

Author Affiliations
  • 1Department of Psychosocial and Community Health, University of Washington, Seattle
  • 2Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington
  • 3Department of Psychology, Université Laval, Quebec City, Quebec, Canada
  • 4Biobehavioral Nursing and Health Systems, University of Washington, Seattle
  • 5Division of Epidemiology and Community Health, Department of Medicine, University of Minnesota, Minneapolis
  • 6Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota
  • 7Division of Women’s Mental Health, Department of Psychiatry, Brigham & Women’s Hospital and Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts
  • 8Department of Psychiatry, Center for Women’s Mental Health, Massachusetts General Hospital, Harvard Medical School, Boston
  • 9Group Health Research Institute, Group Health Cooperative, Seattle, Washington
  • 10Department of Science of Nursing Care, Indiana University, Indianapolis
  • 11Department of Obstetrics and Gynecology, University of Washington, Seattle
  • 12Division of Research, Kaiser Permanente Northern California, Oakland
  • 13Department of Family Medicine and Public Health, University of California–San Diego, La Jolla
JAMA Intern Med. 2016;176(7):913-920. doi:10.1001/jamainternmed.2016.1795

Importance  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).

Design, Setting, and Participants  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.

Interventions  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.

Main Outcomes and Measures  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 and Relevance  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.

Trial Registration  clinicaltrials.gov Identifier: NCT01936441