MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance (MsFLASH-04)
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|ClinicalTrials.gov Identifier: NCT01936441|
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : October 22, 2015
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.
|Condition or disease||Intervention/treatment|
|Hot Flashes Menopause Vasomotor Disturbance Sleep||Behavioral: Cognitive Behavioral Therapy-Insomnia (CBT-I) Behavioral: Menopause Education Control (MEC)|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||November 2013|
|Primary Completion Date :||June 2015|
|Study Completion Date :||June 2015|
Experimental: Cognitive Behavioral Therapy-Insomnia (CBT-I)
Participants will have contact with a menopause counselor 6 times over 8 weeks. The first session will be in-person at a private research office. All other contacts will be by telephone. Women unable to attend the in-person session will receive a phone call. All in-person and telephone consultations will be 20-30 minutes.
Participants will receive reading materials before each phone call relating to menopausal changes, menopausal changes in sleep and strategies for lessening menopause related sleep disturbances. A daily sleep diary will be completed each week during the 8-week intervention period. The day before each telephone session, the participant will email that week's completed diary to a secure email address accessible only by the counselor; women who are unable to use email will provide their data by telephone directly to the counselor. During the weekly telephone calls, the reading and materials will be discussed and the sleep diary will be reviewed.
Behavioral: Cognitive Behavioral Therapy-Insomnia (CBT-I)
See Experimental Arm Description
Placebo Comparator: Menopause Education Control (MEC)
Participants will have contact with a menopause counselor 6 times over 8 weeks. The first session will be in-person at a private research office. All other contacts will be by telephone. Women who are unable to attend the in-person session will receive a phone call. All in-person and telephone consultations are designed to last 20-30 minutes. Participants will receive information about menopausal changes and ways to develop symptom management strategies. Women in the MEC will keep a daily sleep diary. The day before each telephone session, the participant will email that week's completed diary to a secure email address accessible only by the counselor; women who are unable to use email will provide their data by telephone directly to the counselor. During the weekly telephone calls, the reading material will be discussed and the sleep diary will be reviewed.
Behavioral: Menopause Education Control (MEC)
See Experimental Arm Description
- Insomnia Symptoms [ Time Frame: 8 weeks ]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.
- Sleep Quality [ Time Frame: 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936441
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Katherine A Guthrie, PhD||Fred Hutchinson Cancer Research Center|
|Principal Investigator:||Andrea Z LaCroix, PhD||University of California, San Diego|
|Principal Investigator:||Susan M McCurry, PhD||University of Washington|