A Mind-Body Intervention for Hot Flash Management

Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial

The long-term goal of this program of research is to determine safe and effective non-hormonal interventions for menopausal symptoms. The main goal of this study is to evaluate whether self-administered hypnosis can be used to significantly reduce hot flashes more than self-administered white noise hypnosis over 6 weeks of home practice. The investigators are also examining the impact of each hypnosis group on sleep, anxiety, perceived and measured stress, heart rate variability, and daily activities.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Hot Flashes; Postmenopausal Symptoms
• Intervention / Treatment: Behavioral: Self-Administered Hypnosis; Behavioral: Self-Administered White Noise Hypnosis

Detailed Description

This randomized, two arm clinical trial will evaluate the efficacy of self-administered hypnosis for the treatment of hot flashes in postmenopausal women using a 1:1 randomization schedule.

Primary Objective

To evaluate the efficacy of the self-administered hypnosis intervention for hot flashes compared to the self-administered white noise hypnosis.

Hypothesis 1: Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 6 weeks.

Secondary Objectives

To evaluate the efficacy of the self-administered hypnosis compared to self-administered white noise hypnosis for hot flash activity interference, sleep disturbance, anxiety and perception of benefit; with the expectation that there will be significant improvements among participants in the self-administered hypnosis group when compared with the self-administered white noise hypnosis group at 6 weeks. The investigators will also evaluate the effects of self-administered hypnosis compared to the self-administered white noise hypnosis at 12 weeks for all secondary outcomes except perception of benefit. Additionally, mediators (perceived stress, cortisol, and heart rate variability (HRV)) and moderators (hypnotizability and practice adherence) of hot flash reduction will be explored.

Hypothesis 2.1: Compared to self-administered white noise hypnosis, the self-administered hypnosis intervention will result in significant improvements in hot flash activity interference, sleep disturbance, and anxiety at 6 and 12 weeks, and perception of benefit at 6 weeks.

Hypothesis 2.2 A decrease in perceived stress will be indicated in the self-administered hypnosis group due to the intervention, which will correspond and contribute to further decrease of the hot flash score at 6 and 12 weeks.

Hypothesis 2.3 Diurnal salivary cortisol will demonstrate better circadian rhythms (steeper slopes) in those with larger hot flash reductions and in the self-administered hypnosis group compared to participants in the self-administered white noise hypnosis at 6 weeks.

Hypothesis 2.4 Self-administration of hypnosis and greater hot flash reductions will result in higher resting and 24-hour parasympathetic activity, reflected as higher HRV at 6 weeks.

Hypothesis 2.5 Higher hypnotizability scores and better adherence rates will be associated with greater reductions in hot flash scores in the self-administered hypnosis group.

Hypothesis 2.6 Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 12 weeks.

Recruitment Plan

Potential participants will be identified in three ways: postcard mailings and invitation letters; physician referrals and IRB approved chart screening; and flyers, advertisements and press releases. Physician referrals will come primarily from cancer centers at University of Michigan Cancer Center Breast Clinic in Ann Arbor, MI, and the Baylor Scott & White Health Center in Waco, TX.

At Michigan, key eligibility criteria will be used to identify potential eligible women through the Honest Broker Office. Charts will be further screened, with IRB approval, for eligibility. If eligible, women will be sent an invitation letter where they can opt in or out of being contacted to learn more about the study.

In addition, at Michigan, outreach will occur through obstetrics and gynecology, mammography, and internal medicine clinics to enable recruitment of women without a history of breast cancer. Mass mailings and local advertisement may also be used.

At Baylor University, a successful and proven method of accrual has been the use of mass mailings and local advertisement (e.g. newspaper, magazines, flyers). Additionally, Dr. Elkins is a medical associate with Baylor Scott & White Health Center, which provides a direct connection with physicians and medical staff who will provide potential referrals.

It is expected that each site (Baylor University and University of Michigan) will recruit approximately half of the participants. Accrual will be closely monitored and efforts to randomize an equal number at each site will be made.

The study coordinators will provide education about the trial and a consent form for review both by phone and at the baseline/consent session. All other education beyond the baseline data collection will be provided at the second session 7-30 days later. Both sessions will be between 45-60 minutes. Sessions will be held at Dr. Barton's and Dr. Elkin's research offices, which each provide privacy, a recliner, a relaxing environment, and convenient parking.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Texas
    • Waco, Texas, United States, 76798
      • Baylor University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Postmenopausal as defined by one of the following criteria:

• No menstrual period in the past 12 months
• Chemical menopause (LHRH antagonists)
• Surgical Menopause (bilateral oophorectomy)
• Evidence of menopause status per FSH and estradiol levels per institutional guidelines. Self-reported history of a minimum of 4 hot flashes per day or 28 hot flashes per week at baseline.

Age over 18 years and able to give consent for participation in the study.

Have discontinued other putative therapies for hot flashes for at least one month prior to enrollment (Vitamin E will be allowed)

Women with a diagnosis of DCIS or invasive breast cancer stages 0-III are allowed to participate and may be on endocrine therapy of any kind. If on endocrine therapy, women must be on it for 4 weeks and not expected to stop it during the study. If not on endocrine therapy, participants should not be planning to start during the course of the study. However, unexpected treatment will not require study withdrawal but will be recorded and considered in the analysis.

Exclusion Criteria:

• Currently receiving other simultaneous treatment for hot flashes (antidepressant use is allowed if being used for mood alterations and participant has been on the antidepressant for at least 3 months with no plans to change dose or antidepressant during this study)
• Diagnosis of clinical depression or acute anxiety disorder
• Currently using any Complementary and Alternative Medicine (CAM) treatments for vasomotor symptoms. (This would include soy products and other phytoestrogens, black cohosh, and any mind-body techniques including meditation, yoga, etc.). If any therapies are used for reasons other than hot flashes and hot flash frequency meets inclusion criteria, then woman is eligible)
• Diagnosis of a serious psychological illness, specifically psychoses, schizophrenia or borderline personality disorder
• Currently using hypnosis for any reason
• PHQ-4 score ≥ 9
• Non-English speaking
• Women with stage IV breast cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-Administered Hypnosis; Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.	Behavioral: Self-Administered Hypnosis; Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
Active Comparator: Self-Administered White Noise Hypnosis; Self-administered white noise hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.	Behavioral: Self-Administered White Noise Hypnosis; Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hot Flash Daily Diary	Participants completed the Hot Flash Daily Diary (Sloan et al., 2001) every day for 6 weeks to measure the daily frequency and severity (mild, moderate, severe, and very severe) of hot flashes. A total hot flash score was calculated for each participant (product of frequency x severity) after severity ratings were assigned a point value as follows: mild = 1; moderate = 2; severe = 3; very severe = 4 The hot flash score was then calculated by multiplying the participants' frequency and severity ratings of hot flashes, divided by the total number of days. A lower score indicates less frequent and/or severe hot flashes.	The hot flash daily diary was collected at baseline (week 0), endpoint (week 6) and follow-up (week 12).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	This is a 19-item self-report inventory designed to measure sleep disturbance. The 19 items are grouped into 7 sub-scales: 1) sleep quality; 2) sleep efficiency; 3) daytime dysfunction; 4) sleep latency; 5) sleep disturbances; 6) sleep duration; and 7) use of sleep medication.These seven sub-scales are scored on a scale of 0 (better) - 3 (worse) with higher scores indicating greater sleep pathology. The sub-scales are then added for a combined total score ranging from 0 (better) - 21 (worse). Alphas for the Pittsburgh Sleep Quality Index range from .70 to .80.	Baseline, 6, & 12 weeks.
Perceived Stress Scale	This is a 10-item scale that measures the degree to which situations in one's life are appraised as stressful. The scale provides the degree to which individuals find their lives to be unpredictable, uncontrollable, and overloaded, as well as measures the current levels of experienced stress. Items are scored on a scale from 0 (never) - 4(very often) for a total score ranging from 0-40. with higher scores reflecting more perceived stress. This measure has been shown to be valid and internally consistent, with an alpha of .83.	Baseline, 6, & 12 weeks
Hot Flash Related Daily Interference Scale	This is a 10-item scale that measures hot flash interference. The Hot Flash Related Daily Interference Scale asks respondents to rate the degree on a 0 (not at all) - 10 (very much so) scale that the hot flashes interfere with various daily activities as well as overall enjoyment or quality of life. The total score will range from 0-100. The higher the total score, the more likely hot flashes are interfering with the daily activities.This measure has been shown to be valid and internally consistent with Cronbach's alpha of .96.	The Hot Flash Related Daily Interference Scale was completed at Baseline (week 0), at endpoint (week 6) and at follow-up (week 12).
Emotional Distress Anxiety Scale	This 29-item scale measures 5 domains of anxiety: 1) affective, 2)cognitive, 3) somatic, 4) behavioral, and 5) need for treatment. Items are scored on a scale from 1 (never) - 5 (always) with higher scores reflecting more severe anxiety. The total range for this scale is 0-145. This scale has shown excellent convergent and discriminate validity with other measures with a Cronbach's alpha .95.	Baseline, 6 & 12 Weeks
Subject Global Impression of Change	Participants were asked to fill out the Subject Global Impressions of Change at endpoint (week 6) to gauge participants' perceived benefit. The Subject Global Impression of Change is a single item in which the participant rates, from 0 to 4, the change in hot flashes since beginning the study. Response options range from "not at all" (0), "a little" (1), "somewhat" (2), "quite a bit" (3), "totally satisfied" (4). The question used was, "How satisfied are you with the impact of the study treatment on your hot flashes?". This question has been used extensively for determination of minimally clinically significant differences in numerous oncology clinical trials prior to this study.	The Subject Global Impressions of Change will be completed only at 6 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Hypnosis Practice Log	Participants in both groups were given the Self-Hypnosis Practice Log to record daily practice of self-hypnosis or sham hypnosis throughout the 6-week intervention period and at the week 12 follow-up as a measure of intervention adherence. Adherence scores (number of practices per week) were calculated as the total frequency of reported practices according to group assignment in a seven-day period with or without the aid of an audio recording. Average adherence was calculated by averaging the adherence scores of week 1(initiation of study), week 6 (end of intervention), and week 12 (follow-up).	The practice log was completed daily by the participants and submitted to the interventionists at the end of each week throughout the study's duration (weeks one through six) and at follow-up (week 12)."

Collaborators and Investigators

• Sponsor: Baylor University
• Collaborators: University of Michigan; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Gary Elkins, Ph.D., Baylor University; Principal Investigator: Debra Barton, RN,PhD,FAAN, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Actual): February 16, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: June 17, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Hypnosis; Hot Flashes; Postmenopausal Symptoms; Hypnotic Relaxation Therapy; Mind Body
• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: 1237087; R01AT009384 (U.S. NIH Grant/Contract); 2018.063 (Other Identifier: U-M Rogel Cancer Center Protocol Review Committee); HUM00146427 (Other Identifier: U-M Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No