Hypnosis to Improve Sleep In Menopause

NCT02187419 | Completed DMC

• 1 other identifier: R34AT008246-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep

Keywords

Sleep; Menopause; Hypnosis; Relaxation; Hypnotic Relaxation Therapy; Hot Flash

Outcome Measures

Primary Outcomes (1)

• Objective sleep duration

  Wrist actigraphy: Wrist actigraphy is a widely used and well-validated, objective measure of sleep duration. Participants will be asked to wear an Actiwatch 2; Phillips Respironics, which resembles a wrist watch, on their non-dominant wrist. A motion detection device located within the actigraph records movement. After data is collected it will be analyzed using a software program which uses a series of logarithms to measure various factors associated with sleep quality, such as total sleep duration, sleep efficiency, sleep onset latency, and the number of times participants woke during the night. Wrist actigraphy has been used to reliably differentiate the sleeping patterns of men and women. For the present study, participants will be asked to wear the actigraph from baseline assessment throughout the study through week eight. Participants will also complete a Daily Sleep Diary that will be used to help interpret wrist actigraphy data.

  Eight weeks

Secondary Outcomes (9)

• PHQ-8

  Screening

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline, Week 4, Week 6, Week 8

• Insomnia Severity Index (ISI)

  Baseline, Week 4, Week 6, Week 8

• Epworth Sleepiness Scale (ESS)

  Baseline, Week 4, Week 6, Week 8

• Menopausal Rating Scale (MRS)

  Baseline, Week 4, Week 6, Week 8

Study Arms (4)

5 Therapist-Delivered Hypnosis Session

ACTIVE COMPARATOR

Participants will complete five therapist-delivered hypnosis relaxation sessions with a hypnosis research therapist, and receive five audio (CD or MP3) recordings of hypnotic inductions and instructed in daily home practice.

Other: Hypnosis

3 Therapist-Delivered Hypnosis Session

ACTIVE COMPARATOR

Participants will complete three therapist-delivered hypnosis relaxation sessions with a hypnosis research therapist, and receive five audio (CD or MP3) recordings of hypnotic inductions and instructed in daily home practice.

Other: Hypnosis

5 Phone Calls; Hypnosis Recordings Only

ACTIVE COMPARATOR

Participants will complete five phone calls with a hypnosis research therapist, and receive five audio (CD or MP3) recordings of hypnotic inductions and instructed in daily home practice.

Other: Hypnosis

3 Phone Calls; Hypnosis Recordings Only

ACTIVE COMPARATOR

Participants will complete three phone calls with a hypnosis research therapist, and receive five audio (CD or MP3) recordings of hypnotic inductions and instructed in daily home practice.

Other: Hypnosis

Interventions

Hypnosis OTHER

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.

Also known as: Hypnotic Relaxation Therapy

3 Phone Calls; Hypnosis Recordings Only; 3 Therapist-Delivered Hypnosis Session; 5 Phone Calls; Hypnosis Recordings Only; 5 Therapist-Delivered Hypnosis Session

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor University: lead

Study Sites (1)

Mind-Body Medicine Research Lab-Baylor University

Waco, Texas, 76798, United States

Location

Related Publications (2)

• 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.

  PMID: 23435026 BACKGROUND

• Elkins G. Hypnotic Relaxation Therapy: Principles and Applications. New York, NY: Springer Publishing Company; 2013.

  BACKGROUND

Related Links

• Gary Elkins, Baylor University, Department of Psychology \& Neuroscience, School of Arts \& Sciences

MeSH Terms

Conditions

Hot Flashes

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gary R Elkins, PhD

  Baylor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 11, 2014
• Study Start: December 1, 2014
• Primary Completion: February 24, 2017
• Study Completion: February 24, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)