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Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention

Award Number: R01AT011500
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: 09/27/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention - ABSTRACT Cigarette smoking is the leading cause of death accounting for more than 480,000 deaths each year, and 16 million Americans suffer from one or more diseases caused by smoking. Cessation can significantly reduce the risk of disease even for those who have smoked for decades. Interventions using a combination of behavioral approaches that focus on maintaining smokers' motivation to quit, providing specific techniques for quitting and relapse prevention, and using Nicotine Replacement Therapy (NRT) are effective at helping tobacco users quit. However, standard behavioral treatment may not appeal to, or be effective for, some smokers and novel approaches are needed to assist these individuals. Guided Imagery (GI) is a form of mind-body therapy that involves controlled, multi-sensory visualization of specific mental images. GI is an effective therapeutic tool to change behaviors including tobacco use. Multiple studies have shown that exposure to GI results in significantly increased abstinence rates compared to controls or those taking bupropion. A large proportion of the U.S. population uses integrative health approaches. A GI tobacco cessation intervention could appeal to smokers not interested in using a behavioral approach. Although GI is an effective tool for smoking cessation, the mode of delivery has generally been in person, limiting dissemination to large populations. Systematic and meta-analytic reviews have shown that telephone quitlines are a highly scalable way to help individuals quit smoking. Quitlines are available in all 50 U.S. states, Puerto Rico and Guam. The proposed project is highly responsive to PAR-20- 154 by delivering a GI intervention via telephone which is highly scalable and could greatly increase the reach and accessibility of an effective GI smoking cessation intervention. We recently completed a randomized feasibility trial of the Be Smoke Free program. Although not powered to determine efficacy, the intervention showed promise in helping participants to quit and showed high consumer satisfaction. We developed procedures for recruiting participants and surpassed our recruitment goals. We had >90% retention at 8-weeks and >80% at 6-months. We also found high levels of adherence. The results of this randomized feasibility study indicate that a fully powered study of a GI tobacco cessation intervention delivered via telephone is warranted. Therefore, the objective of this R01 application is to conduct a randomized controlled trial to test the efficacy of the Be Smoke Free, telephone-based, GI intervention (IC) for smoking cessation compared to active behavioral control (CC). The study will recruit 1,200 diverse smokers from three states, Arizona, New York, and West Virginia to increase generalizability. Participants will be randomly assigned to receive either the IC or CC delivered by telephone by University of Arizona study coaches and will be assessed at 3- and 6-months post-enrollment by study staff. The primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months. This innovative and rigorously designed project conducted by an experienced team has the potential to improve public health through the delivery of an innovative integrative GI intervention via telephone.


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 = $0 )
2025	2024	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Research and Training in Complementary and Integrative Health	000	4	6/3/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $796,020 )
2024	2024	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Research and Training in Complementary and Integrative Health	001	4	8/19/2024	NON-COMPETING CONTINUATION	$796,020
2024	2023	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Research and Training in Complementary and Integrative Health	000	3	5/28/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $796,020

Issue Date FY: 2023 ( Subtotal = $813,391 )
2023	2023	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Research and Training in Complementary and Integrative Health	001	3	9/1/2023	NON-COMPETING CONTINUATION	$694,240
2023	2023	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Research and Training in Complementary and Integrative Health	002	3	9/18/2023	SUPPLEMENT FOR EXPANSION	$119,151
2023	2022	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Research and Training in Complementary and Integrative Health	000	2	4/6/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $813,391

Issue Date FY: 2022 ( Subtotal = $827,276 )
2022	2022	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Research and Training in Complementary and Integrative Health	002	1	9/20/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Research and Training in Complementary and Integrative Health	000	1	12/10/2021	SUPPLEMENT FOR EXPANSION	$132,200
2022	2022	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Research and Training in Complementary and Integrative Health	001	2	8/15/2022	NON-COMPETING CONTINUATION	$695,076
														Subtotal = $827,276

Issue Date FY: 2021 ( Subtotal = $590,638 )
2021	2021	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Research and Training in Complementary and Integrative Health	001	1	9/29/2021	NEW	$190,638
2021	2021	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Research and Training in Complementary and Integrative Health	000	1	9/24/2021	NEW	$400,000
														Subtotal = $590,638

Grand Total All Awards = $3,027,325

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Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention

Award Number: R01AT011500

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: 09/27/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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