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Abstract
Grant Number: 5U01AT004634-02 Project Title: Hypnosis for Hot Flashes: A Randomized Clinical Trial
PI Information: Name Title ELKINS, GARY R. gary_elkins@baylor.edu Abstract: DESCRIPTION (provided by applicant): Context: Hot flashes are the most severe and frequent menopausal symptom experienced by postmenopausal women and breast cancer survivors. Findings from the Women's Health Initiative that indicate a shift in the risk/benefit balance of hormone therapy has created a pressing need for effective alternative therapies for hot flashes. Our preliminary data indicate that hypnosis can significantly reduce (58-69%) subjectively measured, self-reported hot flash frequency, severity, and interference (i.e. perceived impact) in breast cancer survivors relative to a wait-list control. However, the treatment effectiveness of hypnosis in reducing physiologically measured (i.e. physiologically measured impact) hot flashes with both healthy menopausal women and breast cancer survivors has yet to be established relative to a Structured-Attention Control. [Also, the physiologic mechanism by which hypnosis may operate in reducing hot flashes is unknown. However, by reducing stress hypnosis may indirectly decrease hypothalamic-pituitary-adrenal (HPA) activity. Cortisol is one of the most widely accepted indicators of HPA activity and it is unknown if hypnosis may decrease cortisol in women experiencing hot flashes.] Also, 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 the intervention effectiveness. To our knowledge no previous research has investigated expectancy as a variable regarding any treatment of hot flashes. We hypothesize that hypnosis is a well-tolerated effective intervention to decrease hot flashes in women who are hypnotizable. Objective: (1) Determine the effect of hypnosis intervention on reducing hot flash frequency and severity (perceived impact vs. physiologically measured impact) in menopausal women and breast cancer survivors; (2) Investigate potential moderators of the intervention's effectiveness including cognitive expectancies and hypnotizability scores. (3) Investigate effects of the hypnosis intervention on anxiety, depression, sexual function, sleep quality, and [stress (cortisol).] Design: A stratified randomized design will compare the intervention in menopausal women and breast cancer survivors to an attention-control condition. [Follow-up will be at 12 weeks post-baseline.] Setting and Participants: 200 participants experiencing [7 moderate to severe hot flashes per day or 50 hot flashes weekly] will be recruited from major medical centers in the Eastern and Southwest United States. Intervention: Participants will be randomly assigned to receive five individual sessions of hypnosis or five sessions of structured attention-control condition. Main Outcome Measures: Outcomes will be hot flashes (self-report daily diaries; physiological monitoring; hot flash daily interference), anxiety (State-Trait Anxiety Inventory, VAS ratings), depression (CES-D), sexual function (Sexual Function Scale), sleep quality (Pittsburgh Sleep Quality Index), stress (cortisol), cognitive expectancies (VAS ratings) and hypnotizability (Stanford Hypnotic Susceptibility Scale Form C). If successful, the results of the proposed study will allow for a new non-pharmacological intervention for hot flashes and make novel theoretical contributions to examining the psychological factors that may be associated with changes in hot flashes.
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Institution: BAYLOR UNIVERSITY ONE BEAR PLACE # 97360 WACO, TX 76798 Fiscal Year: 2008 Department: PSYCHOLOGY AND NEUROSCIENCE Project Start: 30-SEP-2007 Project End: 31-MAR-2012 ICD: NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE IRG: ZCA1