A Mind-Body Intervention for Hot Flash Management

• ClinicalTrials.gov Identifier: NCT03572153
• Recruitment Status: Recruiting
• First Posted: June 28, 2018
• Last Update Posted: February 21, 2022
• Sponsor: Baylor University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); University of Michigan
• Information provided by (Responsible Party): Gary R. Elkins, Baylor University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hot Flashes; Postmenopausal Symptoms; Breast Cancer	Behavioral: Self-Administered Hypnosis; Behavioral: Self-Administered White Noise Hypnosis	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 232 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomized and either be assigned to the self-hypnosis group or a self-administered white noise hypnosis group.
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial
• Actual Study Start Date: November 15, 2018
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: March 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Hot Flash Daily Diary [ Time Frame: Daily for 8 total weeks ]
   A Hot Flash Daily Diary will be used to measure the primary outcome of hot flash score. Participants will be asked to complete the Hot Flash Daily Diary every day for 8 weeks total to measure the daily frequency and severity (mild, moderate, severe, and very severe) of their hot flashes. Each level of severity is given a value and participants will rate the severity of each hot flash as they experience it and record it in their daily diary. A total hot flash score will be calculated for each participant.

Secondary Outcome Measures :

1. Hot Flash Related Daily Interference Scale [ Time Frame: Baseline, 6 & 12-Weeks ]
   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.
2. Patient-Reported Outcomes Measurement Information System Emotional Distress Anxiety Scale [ Time Frame: Baseline, 6 & 12 Weeks ]
   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.
3. Pittsburgh Sleep Quality Index [ Time Frame: Baseline, 6, & 12 weeks. ]
   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.
4. Subject Global Impression of Change [ Time Frame: This will be completed only at 6 weeks. ]
   This is a 7-point item in which participants rate the change in hot flashes since beginning the study (ranging from 'very much better', 'moderately better', 'a little better', 'about the same', 'a little worse', 'moderately worse', to 'very much worse'). It has been used extensively for determination of minimally clinically significant differences in numerous oncology clinical trials.Four additional investigator-developed questions about satisfaction are included as well as two questions about the use of the audio recordings.
5. Diurnal Cortisol Rhythm [ Time Frame: Baseline & 6 weeks. ]
   Saliva will be collected three times a day over two consecutive days at two time points during the study. Participants will be provided specific directions for the collection of saliva upon awakening (before getting out of bed), 30 minutes later (before eating, drinking, or tooth brushing), and finally at bedtime (around 10 pm, also before tooth brushing) and will be given a Saliva Collection Diary with questions to answer about their saliva collection. This procedure is well-established and considered valid for the measurement of diurnal cortisol rhythm.
6. Measures of Heart Rate Variability [ Time Frame: Baseline & 6 weeks ]

   The shift in autonomic balance from sympathetic dominance (stress response) to parasympathetic dominance (relaxation response) is a very likely candidate for the underlying mechanism of the effects of mind-body interventions on vasomotor symptoms. Relatedly, an increasing body of evidence indicates that hot flash events are associated with changes in heart rate variability.

   The Polar V800, a mobile HRV recording device, will be worn to collect data over a 24-hour natural ambulatory period as well as two supine standardized 6-minute recording during the two days of cortisol collection. The 24hr and 6 min measurements will be completed (each on separate days) at pre and post-trial.

7. Perceived Stress Scale [ Time Frame: Baseline, 6, & 12 weeks ]
   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.
8. Self-Hypnosis Practice Log [ Time Frame: Daily during weeks 1-6 of the intervention and during week 12. ]
   Participants in both groups will be given a log that will be completed daily. The log will provide space to put the date, whether or not the participant listened to their audio recording, the number of times they practiced (with or without the audio recordings), and provide a space for comments about any interruptions or barriers to listening to their assigned recording.

Other Outcome Measures:

1. Elkins Hypnotizability Scale [ Time Frame: At Baseline ]
   This is a 12-item research assistant administered scale for rating hypnotizability in the general population. The total scale ranges from 0-12. Each item is rated pass/fail, with higher scores indicative of greater hypnotizability. This scale has an excellent reliability with a Cronbach's alpha of .94.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Whitney Williams, M.S.; 254-296-0824; Whitney_Williams@baylor.edu

Contact: Gary Elkins, Ph.D.; 254-296-0643; Gary_Elkins@baylor.edu

Locations

United States, Michigan

University of Michigan; Active, not recruiting

Ann Arbor, Michigan, United States, 48109

United States, Texas

Baylor University; Recruiting

Waco, Texas, United States, 76798

Contact: Whitney Williams, M.S. 254-296-0824 Whitney_Williams@baylor.edu

Contact: Gary Elkins, PhD 254-296-0643 Gary_Elkins@baylor.edu

Principal Investigator: Gary Elkins, Ph.D.

Sponsors and Collaborators

Baylor University

National Center for Complementary and Integrative Health (NCCIH)

University of Michigan

Investigators

• Principal Investigator: Gary Elkins, Ph.D.; Baylor University
• Principal Investigator: Debra Barton, RN,PhD,FAAN; University of Michigan

More Information

• Responsible Party: Gary R. Elkins, Director of Mind-Body Medicine Research Lab, Baylor University
• ClinicalTrials.gov Identifier: NCT03572153
• 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 )
• First Posted: June 28, 2018
• Last Update Posted: February 21, 2022
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gary R. Elkins, Baylor University:

Hot Flashes; Postmenopausal Symptoms; Hypnotic Relaxation Therapy; Mind Body; Hypnosis

Additional relevant MeSH terms:

Hot Flashes