Hypnosis to Improve Sleep In Menopause
Condition: Sleep
Study type: Interventional

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
    

Intervention name(s): Hypnosis
Intervention type(s): Other
Intervention description(s): Hypnosis is a promising, but under-studied non-pharmacological treatment option for poor sleep during the menopausal transition. Hypnosis is a mind-body therapy that may be defined as a deeply relaxed state involving mental imagery and suggestion. The hypnotic state has been described variously as being an altered state of consciousness, focused attention, imaginative involvement, and role assumption.
However, it is generally agreed that hypnosis is a "state or condition, which occurs when appropriate suggestions elicit distortions of perception, memory, or mood". Research has shown that most people are hypnotizable. Hypnosis intervention for managing chronic symptoms usually involves a hypnotic induction, instruction in self-hypnosis and practice using audio recordings.
Other intervention name(s): Hypnotic Relaxation Therapy
Intervention MeSH terms: Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sleep; Menopause; Hypnosis; Relaxation; Hypnotic Relaxation Therapy; Hot Flash