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NCT01936441 · ClinicalTrials.gov registry record · NA
MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance
A NA study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 106
- Enrollment target
NCT01936441 is a NA study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 106 participants.
The verdict
NCT01936441, a NA study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy-Insomnia (CBT-I)
- BEHAVIORAL Menopause Education Control (MEC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01936441
The ClinicalTrials.gov registry entry for NCT01936441 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy-Insomnia (CBT-I) is the first listed.
NCT01936441 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01936441 about?
NCT01936441 is a clinical study titled "MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance". 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 random...
What is the current status of trial NCT01936441?
This trial is currently completed. It is a NA study. The enrollment target is 106 participants. The study started on 2013-11. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01936441?
The interventions under investigation include: Cognitive Behavioral Therapy-Insomnia (CBT-I) (BEHAVIORAL), Menopause Education Control (MEC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01936441?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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