Self-administered hypnosis treatment for the management of hot flashes in women: A randomized clinical trial

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Abstract Hot flashes negatively impact 80% or more of the female population experiencing menopause due to aging and/or diagnosis and treatment for breast cancer, causing decreases in both emotional and physical role functioning. The most effective treatment for hot flashes, estrogen based treatment, is either contraindicated or a cause for worry amongst many women due to cancer and serious side effect risks. Some non-estrogen based treatments have been found effective, but they also can have a negative risk-benefit ratio. Effective, non-hormonal treatments for hot flashes that are not associated with unwanted side effects and are accessible to all women are needed. Hypnotic relaxation therapy is a mind-body intervention that has demonstrated the ability to reduce hot flashes in women experiencing menopause from natural aging as well as breast cancer treatment and has recently been added to a clinical guideline for hot flash management by the North American Menopause Society. However, access to this effective treatment is limited by a lack of trained and/or certified licensed providers. According to an IOM report on women’s health, efforts are needed to be able to translate effective guideline based treatments broadly into practice. This study represents the next step to meet that critical objective. This application proposes a multi-site, two arm, randomized controlled trial with 224 postmenopausal women to accomplish the following specific aims: 1) Evaluate efficacy of a fully self- administered hypnosis compared to an equivalently structured attention control group; 2) Evaluate efficacy of the self-administered hypnosis compared to structured attention for sleep, mood, and hot flash related quality of life, and 3) Explore potential mechanisms by assessing mediators and moderators of effectiveness. This research has the potential to be the gateway to the broad dissemination of a powerful intervention against hot flashes and to illuminate mechanisms of action upon which to build further interventions. This study is innovative because it seeks to deliver a provider intensive therapy in a fully self-administered way, and to explore mechanisms by which it reduces hot flashes.