Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial|
- Hot Flash Score: as derived in a formula using the data from the Hot Flash Daily Symptoms Diary [ Time Frame: Weeks 1-6 and Week 11 ] [ Designated as safety issue: No ]Participants will record the number of hot flashes they experience each day. In addition, they will rate the severity of each hot flash on a 1-4 scale ranging from mild, moderate, severe, to very severe. The formula used is: Score = frequency [ie. number of hot flashes] X average severity
- Hot Flash Related Daily Interference Scale (HFRDIS) [ Time Frame: Week 0, Week 6 and Week 12 ] [ Designated as safety issue: No ]This questionnaire is used to measure the effects of hot flashes on women as they go about their daily activities
- Sternal Skin Conductance Monitor used to physiologically measure skin moisture [ Time Frame: Weeks1, 6, and 11 ] [ Designated as safety issue: No ]As a secondary outcome, hot flashes will be measured using a Biolog. This is a state-of-the-art device that measures changes in skin conductance due to sweating associated with hot flashes. The Biolog will be worn for 24 hours at a time to provide an objective measure of hot flashes during the day and night.
|Study Start Date:||September 2007|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Hypnosis
Receives 5 weeks of hypnotic relaxation therapy
Hypnosis relaxation in five weekly sessions
Placebo Comparator: Structured Attention
Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
Behavioral: Structured Attention
Meets for five weekly sessions for discussion on hot flashes; no hypnosis
Other Name: Structured Attention Control
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293695
|United States, Texas|
|Mind Body Medicine Research Laboratory|
|Waco, Texas, United States, 76798|
|Principal Investigator:||Gary R Elkins, Ph.D.||Baylor University|