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

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.

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