Insomnia is recognized as one of the most prevalent and costly sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition with 40-50% of postmenopausal women (>17 million) having insomnia.5,6 Insomnia associated with menopause has a pattern of sleep disturbance predominantly characterized by sleep maintenance difficulties including frequent awakenings and arousals, reduced sleep efficiency, and overall fragmented sleep. It has recently been demonstrated that this pattern of sleep disturbance, difficulty maintaining sleep, increases throughout the progression of menopause.7 We have recently found sleep maintenance problems in menopause are associated with reduced work performance, increased healthcare utilization, and impaired quality of life.8 Historically, menopausal symptoms including sleep disturbance, were treated using hormone replacement therapy (HRT). However, evidence linking HRT to increased risks of heart disease and cancer have led to a 40% reduction in the use of sex steroid hormones by postmenopausal women and highlight the need for alternative approaches to treatment.9 Importantly, the American Association of Clinical Endocrinologists guidelines for management of menopause do not address treatment of menopausal-related insomnia due to the absence of research findings in this area.10 Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. However, the efficacy of cognitive behavioral therapy for insomnia comorbid with menopause, one of the primary focuses of the present proposal, has not been tested. Traditional CBT-I has disadvantages however, including the need for a trained therapist and significant time commitment on the part of the patient. Therefore, widespread availability of multicomponent CBT-I is limited by the relatively low number of CBT sleep specialists, complexity of therapy, and patient burden. Thus, another aim of this project is to test the acute and long-term efficacy of a single component behavioral therapy for menopausal-related insomnia. Given the significant daytime impairment present in insomnia comorbid with menopause including depression, quality of life, and fatigue, a final aim of this proposal is to determine the efficacyof CBT-I on these measures in women with menopausal-related insomnia.

Public Health Relevance

The project will test the efficacy of cognitive-behavioral therapy for insomnia (CBT-I), as a safe and effective evidence-based alternative to medication for sleep disturbance associated with menopause. Because CBT-I am costly and time intensive, we will also test the efficacy of abbreviated single component sleep restriction therapy (SRT) in the treatment of menopausal-insomnia. Importantly, we will also test the efficacy of each of these treatments on improvements in depression, fatigue, and quality of life.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
1R01NR013959-01A1
Application #
8577148
Study Section
Nursing and Related Clinical Sciences Study Section (NRCS)
Program Officer
Matocha, Martha F
Project Start
2013-09-01
Project End
2018-07-31
Budget Start
2013-09-01
Budget End
2014-07-31
Support Year
1
Fiscal Year
2013
Total Cost
$441,471
Indirect Cost
$133,910
Name
Henry Ford Health System
Department
Type
DUNS #
073134603
City
Detroit
State
MI
Country
United States
Zip Code
48202