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

Award Number: R01AT009384
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/22/2017
PERIOD OF PERFORMANCE END DATE: 08/31/2023

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$33,364 )
2025	2021	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	001	5	5/6/2025	SUPPLEMENT FOR EXPANSION	-$11,162
2025	2021	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	000	5	5/6/2025	NON-COMPETING CONTINUATION	-$22,202
														Subtotal = -$33,364

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	000	5	9/10/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	000	5	8/17/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $1,006,937 )
2021	2021	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	001	5	8/20/2021	NON-COMPETING CONTINUATION	$670,065
2021	2021	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	002	5	8/23/2021	SUPPLEMENT FOR EXPANSION	$336,872
2021	2020	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	000	4	6/17/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,006,937

Issue Date FY: 2020 ( Subtotal = $991,491 )
2020	2020	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	004	4	8/7/2020	SUPPLEMENT FOR EXPANSION	-$56,102
2020	2020	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	002	4	8/3/2020	NON-COMPETING CONTINUATION	$692,450
2020	2020	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	003	4	8/5/2020	SUPPLEMENT FOR EXPANSION	$355,143
2020	2019	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	001	3	1/28/2020	NON-COMPETING CONTINUATION	$0
2020	2019	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	000	3	12/20/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $991,491

Issue Date FY: 2019 ( Subtotal = $697,722 )
2019	2019	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	002	3	8/12/2019	NON-COMPETING CONTINUATION	$697,722
2019	2018	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	000	2	10/29/2018	NON-COMPETING CONTINUATION	$0
2019	2018	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	001	2	12/17/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $697,722

Issue Date FY: 2018 ( Subtotal = $713,061 )
2018	2018	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	001	2	8/9/2018	NON-COMPETING CONTINUATION	$713,061
2018	2017	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	000	1	8/9/2018	NEW	$0
														Subtotal = $713,061

Issue Date FY: 2017 ( Subtotal = $748,643 )
2017	2017	BAYLOR UNIVERSITY	700 S UNIVERSITY PARKS DR	WACO	TX	76706	MCLENNAN	USA	Research and Training in Complementary and Integrative Health	000	1	9/22/2017	NEW	$748,643
														Subtotal = $748,643

Grand Total All Awards = $4,124,490

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

Award Number: R01AT009384

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/22/2017

PERIOD OF PERFORMANCE END DATE: 08/31/2023

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