View Clinical Trial (Medical Research Study)
Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
| City: |
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Waco |
| State: |
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Texas |
| Zip Code: |
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76798 |
| Conditions: |
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Hot Flashes |
| Purpose: |
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The purpose of this study is 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.
A second purpose of this study is to investigate potential moderators of the intervention's
effectiveness including cognitive expectancies and hypnotizability scores. It is predicted
that cognitive expectations will moderate the effect of the intervention on
post-intervention hot flash scores and that hypnotizability scores will moderate the effect
of the Hypnosis Intervention on post-intervention hot flash scores.
A third purpose will be to investigate effects of the Hypnosis Intervention on self-reported
anxiety, depression, sexual function, and sleep quality; and cortisol levels. It is
predicted that there will be significant reductions in self-reported anxiety, depression;
improvement in self-reported sexual function and sleep quality; and decreases in cortisol
relative to a Structured-Attention Control. It is felt that hot flash severity and
interference will mediate the effect of the hypnosis intervention on self-reported anxiety,
depression, sexual activity, and sleep quality.
To achieve these aims, 180 post-menopausal women with hot flashes will be randomly assigned
to either the Hypnosis Intervention or Structured-Attention Control. The proposed research
is significant because it will establish the applicability of hypnosis to reduce hot flashes
and will make novel theoretical contributions by examining psychological and physiological
factors that may be associated with changes in hot flashes, which may have important
implications for clinical practice and future research. This study is the next step in our
long-range goal eventually to develop an effective hypnosis package that can be delivered as
a routine part of medical care offered to women with hot flashes.
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| Study Summary: |
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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. Our preliminary data indicate that hypnosis can
significantly reduce (up to 58-69%) subjectively measured, self-reported hot flash
frequency, severity, and interference (i.e. perceived impact). 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.
However, psychological stress is often cited as a precipitant for hot flashes. This may
represent alternations in hypothalamic-pituitary-adrenal (HPA) activity. By reducing stress
and increasing physiological control, hypnosis may indirectly decrease HPA activity.
Responses to stress are mediated by the sympathetic nervous system and the
hypothalamic-pituitary-adrenal (HPA) axis. Cortisol is released by the adrenal gland and is
one of the most widely accepted indictors of HPA axis activation; the hypnosis intervention
may result in decreased cortisol. Further, potential moderators of the efficacy of hypnosis
for hot flashes have not been previously studied. Potential moderators may include
individual differences in hypnotizability and cognitive expectations for intervention
effectiveness. To our knowledge no previous research has investigated expectancy as a
variable regarding any treatment of hot flashes. Also, because our preliminary data suggest
that hypnosis may have additional benefits, such as reduced self-reported anxiety and
depression, improved sleep and sexual function, these outcomes warrant further
investigation. 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. Outcomes will be hot flashes (self-report daily diaries; physiological monitoring;
Hot Flash Related Daily Interference Scale), anxiety (State-Trait Anxiety Inventory;
Hospital Anxiety and Depression Scale (HADS); anxiety visual analog scale (VAS rating);
depression (Center for Epidemiologic Studies Depression Scale ), sexual functioning (Sexual
Activity Questionnaire), sleep quality (Pittsburgh Sleep Quality Index) and cortisol;
moderators will be cognitive expectancies (VAS ratings) and hypnotizability (Stanford
Hypnotic Susceptibility Scale-Form C and Elkins Hypnotizability Scale).
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| Criteria: |
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Inclusion Criteria:
- post menopausal
- experiencing at least 7 hot flashes per day
Exclusion Criteria:
- using HRT or other complementary means for the purpose of reducing hot flashes
- using hypnosis for any reason
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| NCT ID: |
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NCT01293695 |
| Primary Contact: |
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Principal Investigator
Gary R Elkins, Ph.D.
Baylor University
Vicki D Patterson, CRC
Phone: 254-296-0824
Email: vicki_patterson@baylor.edu
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| Backup Contact: |
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Email: rachel_kressin@baylor.edu
Rachel M Zamzow, BA
Phone: 254-296-0824
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| Location Contact: |
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Waco, Texas 76798
United States
Vicki D Patterson, CRC
Phone: 254-296-0824
Email: vicki_patterson@baylor.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
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