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A Randomized Controlled Trial of A Digital, Self-Guided, Avatar Assisted- Cognitive Behavioral Therapy Platform to Treat Addiction: Digital RITch®CBT vs. Standard CBT

Award Number: UG3DA057042
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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A Randomized Controlled Trial of A Digital, Self-Guided, Avatar Assisted- Cognitive Behavioral Therapy Platform to Treat Addiction: Digital RITch®CBT vs. Standard CBT - Project Summary Substance User Disorders (SUDS) and Intimate partner violence (IPV) are devastating to families and society (CT CASE, 2015) costing $700 billion annually in healthcare expenditures for SUDS and $12.6 billion in annual costs for IPV. There is a high co-occurrence of substance use and IPV (IPV; CT CASE, 2015). Rates of SUDS and IPV increased during the Covid-19 pandemic (Dubey et al., 2020) at a time period when access to care was disrupted in the absence of Telehealth or Digital Therapy Platforms. The alarmingly higher rates of SUDS and IPV during the pandemic underscored the need for more clinical research trials for device and digital technology developments (DTx). CBT is an evidence based therapy vehicle that has been shown to be effective in improving treatment outcomes across a number of behavioral health disorders (Dutra et al., 2008) including initial efficacy in treating substance abuse and IPV among male offenders in an individual (1:1) CBT therapy modality (Easton et al., 2017). Recent meta-analytic reviews report that digitized versions of CBT are showing effectiveness in treating a range of maladaptive behaviors (Spek et al., 2007) as well as SUDS (Carroll and colleagues, 2014; Carroll et al., 2008) but are limited digital versions that lack personalization and relevant content to patients self-reported symptom distress. To date, digitized platforms have not been used to treat SUDS and IPV among clients entering substance abuse treatment. Researchers are calling for more RCTs using DTx’s of CBT as a vehicle for healthy behavior change among SUD - IPV clients (Nesset and colleagues, 2019). Given our prior success with CBT to treat both SUDS and IPV across 12 weeks of 1:1 treatment, we extended our integrated CBT therapy to a DTx platform. DTx platforms are advantageous because they are easy to disseminate, cost-effective, lead to increases in clients’ engagement and maximize compliance with practice exercises. The technology that exists today is modernized to allow for personalized therapy content to be linked to reported symptom distress. We developed a 12- week digital, Avatar Assisted, interactive platform, RITch®CBT, as an intervention platform self -guided by patients and for patients to use “at home” to practice coping skill exercises at their convenience. In response to NIH’s PAR 21-183, we propose to conduct a Phase I and II Study: UG3 (Phase I) and UH3 (Phase II) in collaboration with the FDA regarding ongoing feedback and regulatory processes. In Phase I, we propose a feasibility study, a randomized controlled trial to test the efficacy of RITch®CBT among SUD-IPV clients entering addiction treatment comparing it to face to face 1:1 CBT. If efficacy is achieved, an effectiveness study will be performed in Phase II (UH3) to improve treatment outcomes among individuals and their families suffering from co-occurring SUDS and IPV, a common co-occurring problem within families across the U.S.


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: 2026 ( Subtotal = $0 )
2026	2023	UNIVERSITY OF ROCHESTER	910 GENESEE ST	ROCHESTER	NY	14611	MONROE	USA	Drug Use and Addiction Research Programs	000	3	12/16/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2026	2023	UNIVERSITY OF ROCHESTER	910 GENESEE ST	ROCHESTER	NY	14611	MONROE	USA	Drug Use and Addiction Research Programs	002	3	7/20/2026	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2026	2023	ROCHESTER INSTITUTE OF TECHNOLOGY	1 LOMB MEMORIAL DR	ROCHESTER	NY	14623	MONROE	USA	Drug Use and Addiction Research Programs	001	2	3/12/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = -$1 )
2025	2023	ROCHESTER INSTITUTE OF TECHNOLOGY	1 LOMB MEMORIAL DR	ROCHESTER	NY	14623	MONROE	USA	Drug Use and Addiction Research Programs	001	2	8/25/2025	NON-COMPETING CONTINUATION	-$501,537
2025	2023	ROCHESTER INSTITUTE OF TECHNOLOGY	1 LOMB MEMORIAL DR	ROCHESTER	NY	14623	MONROE	USA	Drug Use and Addiction Research Programs	000	2	7/24/2025	NON-COMPETING CONTINUATION	$0
2025	2023	UNIVERSITY OF ROCHESTER	910 GENESEE ST	ROCHESTER	NY	14611	MONROE	USA	Drug Use and Addiction Research Programs	002	3	8/25/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$501,536
														Subtotal = -$1

Issue Date FY: 2023 ( Subtotal = $521,734 )
2023	2023	ROCHESTER INSTITUTE OF TECHNOLOGY	1 LOMB MEMORIAL DR	ROCHESTER	NY	14623	MONROE	USA	Drug Use and Addiction Research Programs	002	2	8/18/2023	NON-COMPETING CONTINUATION	$521,734
2023	2022	ROCHESTER INSTITUTE OF TECHNOLOGY (INC)	1 LOMB MEMORIAL DR	ROCHESTER	NY	14623	MONROE	USA	Drug Use and Addiction Research Programs	000	1	12/28/2022	NEW	$0
2023	2022	ROCHESTER INSTITUTE OF TECHNOLOGY	1 LOMB MEMORIAL DR	ROCHESTER	NY	14623	MONROE	USA	Drug Use and Addiction Research Programs	001	1	4/21/2023	NEW	$0
														Subtotal = $521,734

Issue Date FY: 2022 ( Subtotal = $804,694 )
2022	2022	ROCHESTER INSTITUTE OF TECHNOLOGY (INC)	1 LOMB MEMORIAL DR	ROCHESTER	NY	14623	MONROE	USA	Drug Use and Addiction Research Programs	001	1	9/27/2022	NEW	$10,000
2022	2022	ROCHESTER INSTITUTE OF TECHNOLOGY (INC)	1 LOMB MEMORIAL DR	ROCHESTER	NY	14623	MONROE	USA	Drug Use and Addiction Research Programs	000	1	9/26/2022	NEW	$794,694
														Subtotal = $804,694

Grand Total All Awards = $1,326,427

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A Randomized Controlled Trial of A Digital, Self-Guided, Avatar Assisted- Cognitive Behavioral Therapy Platform to Treat Addiction: Digital RITch®CBT vs. Standard CBT

Award Number: UG3DA057042

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/30/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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