Hypnosis to Improve Sleep In Menopause

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 dose (3 vs. 5 sessions) and delivery method (audio recorded vs. therapist
delivered) are as yet unknown. It is hypothesized that a hypnosis program will indicate an
effect on objectively measured sleep duration. It is expected that one or more hypnosis
interventions will have effects on both the primary outcome (objectively measured sleep
duration) and secondary outcomes (sleep quality, insomnia symptom severity, daytime
sleepiness, menopausal symptoms, pain, and bothersomeness).

This study will provide estimated effect sizes for the primary and secondary outcomes for
later studies. In addition, it is possible that there are potential covariates such as age,
race, menopausal stage, sleep environment, and/or socioeconomic status that require
consideration. These will be explored (Aim 4) to guide the future, larger study.

Stratified randomization will be utilized, with one variable present in the randomization:
the presence/absence of hot flash . "Presence" of hot flash is determined by criteria used
in a prior study (i.e., 7 hot flashes per day, or 50 hot flashes per week) during the
screening or baseline week. If the criteria is not met that indicates presence of hot
flashes and reported during those two weeks, then the woman will be determined as not having
hot flashes.

Objectives

- Aim 1: Determine the feasibility of and adherence to the four hypnosis programs.
Feasibility will be determined by (1) a dropout rate of less than 25%, (2)
participants' rating of the program (from poor to excellent; with rating of good or
better defined as feasible), (3) participants' rating of treatment satisfaction (from
completely satisfied to completely dissatisfied) and (4) few adverse events (<5%).
Adherence will be determined through daily at-home practice forms. An adherence
threshold of 75% will be utilized as this level of adherence is likely to be needed for
an optimal hypnosis program for sleep.

- Aim 2: Determine initial effect sizes for the primary outcome of objectively measured
sleep duration, including the percent of women who achieve a clinically meaningful
improvement. Wrist actigraphy recordings supplemented by sleep diaries will be used to
measure sleep duration. Clinically meaningful improvement is defined as the percentage
of women who move from poor to average sleep duration (e.g., from < 6.5 hours per night
to > 6.5 hours but <9.0 per night).

- Aim 3: Determine initial effect sizes for secondary outcomes of sleep quality, insomnia
symptom severity, daytime sleepiness, menopausal symptoms, and pain.

- Aim 4: Examine trends in potential covariates including endogenous factors (e.g., age,
race/ethnicity, menopausal status) and exogenous factors (e.g., sleep environment,
socioeconomic status).

Study Design

This study is designed as a 4-arm comparison, with participants randomized to the following
arms:

1. Standard audio recordings for home practice, with 5 in-person therapist delivered
hypnotic inductions

2. Standard audio recordings for home practice, with 3 in-person therapist delivered
hypnotic inductions

3. Standard audio recordings only, with 5 telephone contacts to encourage home practice

4. Standard audio recordings only, with 3 telephone contacts to encourage home practice

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]