Clinical trial NCT02187419: Hypnosis to Improve Sleep In Menopause
Official title: Hypnosis to Improve Sleep in Menopause: Determination of Optimal Dose and Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Sleep
Menopause
Hypnosis
Relaxation
Hypnotic Relaxation Therapy
Hot Flash
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 84
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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(s) will be feasible and will exhibit acceptable adherence. The programs will assess to determine optimal dose (3 vs 5 sessions) and method (audio-recorded vs therapist delivered).

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 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

Eligibility criteria: 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 \[NOTE: Providing hypnosis is highly dependent on the use of language. While it would be possible to recruit a Spanish speaking hypnotherapist, none of the investigators speak Spanish and this would make it extremely difficult (if not unethical) to provide supervision to a Spanish speaking hypnotherapist. Because of this we have elected to restrict participants to those that are English speaking\]

Primary outcomes:
measure: Objective sleep duration
timeFrame: Eight weeks
Secondary outcomes:
measure: PHQ-8
timeFrame: Screening
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, Week 4, Week 6, Week 8
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, Week 4, Week 6, Week 8
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, Week 4, Week 6, Week 8
measure: Menopausal Rating Scale (MRS)
timeFrame: Baseline, Week 4, Week 6, Week 8
measure: Pain Visual Analog Scale (VAS)
timeFrame: Baseline, Week 4, Week 6, Week 8
measure: Bothersomeness Numeric Rating Scale (NRS)
timeFrame: Baseline, Week 4, Week 6, Week 8
measure: Demographic Questionnaire
timeFrame: Baseline
measure: Sleep environment
timeFrame: Baseline, Week 4, Week 6, Week 8
Other outcomes:
Locations:
city: Waco
country: United States
facility: Mind-Body Medicine Research Lab-Baylor University
state: Texas
Study officials:
affiliation: Baylor University
name: Gary R Elkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elkins GR, Fisher WI, Johnson AK, Carpenter JS, Keith TZ. Clinical hypnosis in the treatment of postmenopausal hot flashes: a randomized controlled trial. Menopause. 2013 Mar;20(3):291-8. doi: 10.1097/gme.0b013e31826ce3ed.
citation: Elkins G. Hypnotic Relaxation Therapy: Principles and Applications. New York, NY: Springer Publishing Company; 2013.