MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance

Sleep Clinical Trial

— MsFLASH-04  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936441
• Other study ID #: MsFLASH-04
• Secondary ID: 1U01AG032699-01
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: October 21, 2015
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Hot Flashes
• Menopause
• Parasomnias
• Sleep
• Sleep Disorders
• Vasomotor Disturbance

Intervention

Behavioral:
• Cognitive Behavioral Therapy-Insomnia (CBT-I)
See Experimental Arm Description
• Menopause Education Control (MEC)
See Experimental Arm Description

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Symptoms	The primary outcome is insomnia symptoms as assessed by the Insomnia Severity Index (ISI). The primary objective of this pilot trial is to determine the efficacy of Cognitive Behavioral Therapy-Insomnia (CBT-I) vs. Menopause Education Control (MEC) in improving insomnia symptoms among mid-life women with menopause-related sleep disturbance. 24-week follow-up will be additionally assessed.	8 weeks	No
Secondary	Sleep Quality	The secondary outcome is self-reported sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI). 24-week follow-up will be additionally assessed.	8 weeks	No