Clinical trial NCT01936441: MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance
Official title: Menopausal Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) 04: A Pilot Trial of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women With Menopause-related Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Menopause
Vasomotor Disturbance
Sleep
Keywords: Menopause
Vasomotor
Symptoms
Sleep
Cognitive Behavioral Therapy
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-09-06
Enrollment: 106
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Self-reported sleep complaints are common in peri- and postmenopausal women and have been identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related Sleep Disturbance, is a randomized, single-blind, placebo-controlled, two arm clinical trial. The target population will include women in general good health, aged 40-65 years, who report symptoms of insomnia (trouble sleeping) and who are bothered by hot flashes. We plan to enroll 100 women from Seattle, Washington and surrounding areas into the trial. Half of the women will be randomly assigned to receive the behavioral intervention and half to receive the behavioral control.

The intervention arm participants will receive 6 sessions of a telephone-based, cognitive-behavioral therapy intervention for insomnia (CBT-I), based on state-of-the-art methods and specifically targeted to women with menopause-related sleep disturbance (CBT-I). The control arm participants will receive telephone-based Menopause Education Control (MEC) that includes elements of sleep hygiene. Assessments for both groups will be collected at baseline (pre-randomization), 8-week post-randomization, and 6-month post-randomization.

The inclusion/exclusion criteria are designed to target broadly those midlife women who have menopause-related sleep disturbance and also report being bothered by vasomotor symptoms. This target population defines the clinical population seeking treatment for relief of menopause-related sleep problems. Exclusion criteria are kept minimal and intended only to exclude women with significant medical problems likely to account for their sleep problems (instead of menopause), or likely to interfere with their ability to participate in the intervention. We include women taking hormone therapy or other medication who meet these criteria because they are part of the population seeking clinical care for relief of sleep disturbances.

Our primary objective is to develop an intervention that is generalizable to the greatest number of women and maximally translatable into real-world primary care practice.


Eligibility criteria: Inclusion Criteria:

* Female aged 40-65 years old
* Postmenopausal or perimenopausal, including:

  * Women with a uterus who have skipped 2 or more menstrual cycles with an amenorrhea interval \>=60 days in the past 12 months
  * Women without a uterus or who have had a bi-lateral oophorectomy
* Experiencing hot flashes
* Experiencing insomnia (trouble sleeping) that is related to menopause
* Written informed consent signed

Exclusion Criteria:

* Pregnancy, intending pregnancy, or breastfeeding
* Current use of alcohol that is greater than 3 drinks per day
* Ever diagnosed for sleep apnea, restless legs syndrome, periodic leg movement disorder, random eye movement (REM) behavior disorder, or narcolepsy by a health care provider
* A job in the past month or planning to have a job in the next 3 months that requires shift work more than 3 times a week that involves working at night or on a rotating shift schedule
* Significant current major illness interfering with sleep or intervention participation (such as active cancer)
* Use of any prescription sleep medications more than 3 times a week or prescription medications that may affect sleep
* Use of over-the-counter medications more than three times a week that are specifically for sleep, such as Tylenol PM, Nytol, Sominex, Tranquil Nighttime Sleep Aid, Unisom, ZzzQuil, benedryl, melatonin, valerian root, alcohol
* Current participation in another intervention study
* Inability or unwillingness to complete study procedures

Primary outcomes:
measure: Insomnia Symptoms
timeFrame: 8 weeks
Secondary outcomes:
measure: Sleep Quality
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Katherine A Guthrie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Andrea Z LaCroix, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Susan M McCurry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diem SJ, LaCroix AZ, Reed SD, Larson JC, Newton KM, Ensrud KE, Woods NF, Guthrie KA. Effects of pharmacologic and nonpharmacologic interventions on menopause-related quality of life: a pooled analysis of individual participant data from four MsFLASH trials. Menopause. 2020 Oct;27(10):1126-1136. doi: 10.1097/GME.0000000000001597.
citation: Guthrie KA, Larson JC, Ensrud KE, Anderson GL, Carpenter JS, Freeman EW, Joffe H, LaCroix AZ, Manson JE, Morin CM, Newton KM, Otte J, Reed SD, McCurry SM. Effects of Pharmacologic and Nonpharmacologic Interventions on Insomnia Symptoms and Self-reported Sleep Quality in Women With Hot Flashes: A Pooled Analysis of Individual Participant Data From Four MsFLASH Trials. Sleep. 2018 Jan 1;41(1):zsx190. doi: 10.1093/sleep/zsx190.
citation: McCurry SM, Guthrie KA, Morin CM, Woods NF, Landis CA, Ensrud KE, Larson JC, Joffe H, Cohen LS, Hunt JR, Newton KM, Otte JL, Reed SD, Sternfeld B, Tinker LF, LaCroix AZ. Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):913-20. doi: 10.1001/jamainternmed.2016.1795.