Clinical trial NCT03572153: A Mind-Body Intervention for Hot Flash Management
Official title: Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Postmenopausal Symptoms
Breast Cancer
Keywords: Hot Flashes
Postmenopausal Symptoms
Hypnotic Relaxation Therapy
Mind Body
Hypnosis
Lead sponsor: Baylor University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: University of Michigan
First posted: 2018-06-28
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized and either be assigned to the self-hypnosis group or a self-administered white noise hypnosis group.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Hot Flash Daily Diary
timeFrame: The hot flash daily diary was collected at baseline (week 0), endpoint (week 6) and follow-up (week 12).
Secondary outcomes:
measure: Hot Flash Related Daily Interference Scale
timeFrame: The Hot Flash Related Daily Interference Scale was completed at Baseline (week 0), at endpoint (week 6) and at follow-up (week 12).
measure: Emotional Distress Anxiety Scale
timeFrame: Baseline, 6 & 12 Weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 6, & 12 weeks.
measure: Subject Global Impression of Change
timeFrame: The Subject Global Impressions of Change will be completed only at 6 weeks.
measure: Perceived Stress Scale
timeFrame: Baseline, 6, & 12 weeks
Other outcomes:
measure: Self-Hypnosis Practice Log
timeFrame: 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)."
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: Baylor University
name: Gary Elkins, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Debra Barton, RN,PhD,FAAN
role: PRINCIPAL_INVESTIGATOR
References: