Status:
COMPLETED
Hypnosis to Improve Sleep In Menopause
Lead Sponsor:
Baylor University
Conditions:
Sleep
Eligibility:
FEMALE
40-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine feasibility and adherence to a hypnosis program to improve sleep. It is theorized (based on prior experience and pilot data) that one or more hypnosis program...
Detailed Description
It is conceptually theorized that one or more hypnosis program(s) \[dose and delivery\] will be feasible and will exhibit acceptable adherence to daily hypnosis practice to improve sleep. The optimal ...
Eligibility Criteria
Inclusion
- Inclusion criteria are:
- Females, aged 40-65. (This proposed range is based on the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) criteria to identify symptomatic women in the menopausal transition and to allow for comparison to other studies of this target population)
- Self-reported sleep duration of ≤6 hours per day/night for 5 or more nights per week as determined by a 7-day sleep diary during screening and baseline weeks
- Post-menopausal or in the late perimenopausal transition, defined as ≥ 2 missed menstrual cycles with an interval of amenorrhea ≥ 60 days in the past 12 months
- In general good health as determined by medical history and physical measures
- Non-depressed as determined by Patient Health Questionnaire (PHQ-8) scores ≤ 9
- Signed informed consent
- Exclusion criteria are:
- Use of hormone therapy or hormonal contraceptives during the 2 months before enrollment and for the duration of the study
- Self-report of sleep apnea and/or restless leg syndrome
- Use of any prescription or over-the-counter therapy for sleep (i.e. Melatonin, valerian, other "natural" sleep aids, and commonly used over-the-counter (OTC) medications \[e.g. acetaminophen + diphenhydramine or equivalent\]) \[NOTE: Medications not intended for sleep but that have a known impact on sleep will be allowed (i.e. serotonin-norepinephrine reuptake inhibitors-SNRIs, selective serotonin re-uptake inhibitors-SSRIs)\]
- Severe or unstable medical or psychiatric illness
- Current use of hypnosis for any condition
- Inability to speak or understand English \[NOTE: Providing hypnosis is highly dependent on the use of language. While it would be possible to recruit a Spanish speaking hypnotherapist, none of the investigators speak Spanish and this would make it extremely difficult (if not unethical) to provide supervision to a Spanish speaking hypnotherapist. Because of this we have elected to restrict participants to those that are English speaking\]
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2017
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02187419
Start Date
December 1 2014
End Date
February 24 2017
Last Update
April 13 2017
Active Locations (1)
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1
Mind-Body Medicine Research Lab-Baylor University
Waco, Texas, United States, 76798