Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial

NCT ID: NCT01293695

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2014-03-31

Brief Summary

This study is designed to determine the effect of a Hypnosis Intervention on reducing hot flash frequency (perceived impact vs. physiologically measured impact), severity and daily interference in post-menopausal women. It is felt that the Hypnosis Intervention will result in significantly lower hot flash frequency, severity and daily interference scores (perceived impact vs. physiologically measured impact) versus Structured-Attention Control.

Detailed Description

The aging population of the United States and findings from the Women's Health Initiative that indicate a shift in the risk/benefits balance of hormone therapy have created a growing interest in alternative treatments for hot flashes. Hot flashes are among the most severe and frequent symptoms experienced by women during menopause. Over 66% of post-menopausal women experience hot flashes. As a result, there is a pressing need for safe and effective treatments for hot flashes. Hypnosis is one mind-body therapy that seems particularly promising for treating hot flashes.

However, the treatment effectiveness of hypnosis in reducing physiologically measured (i.e. physiologically measured impact) hot flashes with post-menopausal women has yet to be established relative to a Structured-Attention Control. This is a critical step to further investigate the intervention and to determine if hypnosis reduces the symptoms (i.e. the number of physiological hot flashes) or only the women's perception of symptoms.

Also, the physiologic mechanism by which hypnosis may operate in reducing hot flashes is not known. The present study will compare hypnosis to a Structured-Attention Control in reducing hot flashes (perceived and physiologically monitored) in post-menopausal women in a randomized clinical trial.

Innovations of this study are that it will be the first full scale test of hypnosis for hot flashes; one of the first studies to examine both perceived impact and physiologically measured impact of a mind-body intervention for hot flashes using state-of-the-art 24 hour ambulatory physiological monitoring; the first study to examine the effect of hypnosis for hot flashes on cortisol; and the first investigation of the role of cognitive expectancies in treatment of hot flashes in comparison to a Structured-Attention Control.

Conditions

Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hypnosis

Receives 5 weeks of hypnotic relaxation therapy

Group Type: ACTIVE_COMPARATOR

Hypnosis

Intervention Type: BEHAVIORAL

Hypnosis relaxation in five weekly sessions

Structured Attention

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Group Type: PLACEBO_COMPARATOR

Structured attention

Intervention Type: OTHER

Meets with therapist for five weekly sessions and receives structured attention/supportive counseling, but receives no hypnotic relaxation therapy

Interventions

Hypnosis

Hypnosis relaxation in five weekly sessions

Intervention Type: BEHAVIORAL

Structured attention

Meets with therapist for five weekly sessions and receives structured attention/supportive counseling, but receives no hypnotic relaxation therapy

Intervention Type: OTHER

Other Intervention Names

Hypnotic relaxation therapy; Hypnosis relaxation; Hypnotic intervention; Hypnosis intervention; Placebo Comparator

Eligibility Criteria

Inclusion Criteria

• Postmenopausal as defined by:

1. no menstrual period in the past 12 months;

2. no menstrual period in the past 6 months and a medically documented history of FSH level greater than 40; or

3. women who have had a bilateral oophorectomy.

• A self-reported history of a minimum of 7 hot flashes per day or 50 hot flashes per week at baseline.
• Age over 18 years and ability to give her own consent for participation in the study.
• Have discontinued other putative therapies for hot flashes for at least one month prior to enrollment
• Ability to attend weekly sessions.

Exclusion Criteria

• Receiving other simultaneous treatment for hot flashes.
• Using any CAM (Complementary and Alternative Medicine) treatments for vasomotor symptoms • Any medical or psychiatric condition that in the opinion of the investigator puts the participant at potential risk during the study.
• Currently using hypnosis for any reason.
• Inability to speak or understand English

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Baylor University

OTHER

Sponsor Role: lead

Responsible Party

Gary R. Elkins

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary R Elkins, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Locations

Mind-Body Medicine Research Lab-Baylor University

Waco, Texas, United States

Countries

United States

References

Roberts RL, Rhodes JR, Elkins GR. Effect of Hypnosis on Anxiety: Results from a Randomized Controlled Trial with Women in Postmenopause. J Clin Psychol Med Settings. 2021 Dec;28(4):868-881. doi: 10.1007/s10880-021-09810-3. Epub 2021 Aug 17.

Reference Type: DERIVED

PMID: 34403019 (View on PubMed)

Elkins GR, Fisher WI, Johnson AK. Hypnosis for hot flashes among postmenopausal women study: a study protocol of an ongoing randomized clinical trial. BMC Complement Altern Med. 2011 Oct 11;11:92. doi: 10.1186/1472-6882-11-92.

Reference Type: DERIVED

PMID: 21989181 (View on PubMed)

Other Identifiers

5U01AT004634

Identifier Type: NIH

Identifier Source: secondary_id

View Link

194610

Identifier Type: -

Identifier Source: org_study_id