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Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)

Award Number: UG3NR019196
ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE) - Chronic musculoskeletal pain (CMP) is the most common, disabling, and costly of all pain problems. While evidence exists for the efficacy (albeit modest benefits) of both duloxetine and web-based cognitive behavioral therapy (CBT) as monotherapy, it is time to consider study of treatment components that may complement each other. In addition, given the reported association between patient’s adherence and treatment outcomes, strategies are needed to enhance participant’s motivation to maintain continued use of newly learned pain coping skills from CBT. Using motivational interviewing (MI), a phone based adherence-focused guidance by a nurse clinician could make web-based CBT more effective. The objective of the UH3 application is to determine if combination therapy (duloxetine + web-based CBT) is more effective than duloxetine monotherapy for treating patients with CMP. Given the interactions of biological, behavioral and psychological mechanisms in the pathogenesis of chronic pain, our central hypothesis is that combination therapy will be more effective than duloxetine monotherapy. The objective of this UG3/UH3 application is to conduct a 24-week randomized clinical trial of primary care patients with CMP. In the UH3 trial, 450 participants will be randomized to one of three treatments: (1) combination treatment [duloxetine + web-based CBT] with nurse support, (2) combination treatment without nurse support, and (3) duloxetine monotherapy. This project could optimize pain-related treatment outcomes by combining duloxetine and web-based CBT at the primary care level where most pain patients are managed. Importantly, the use of nurse clinician providing adherence-focused guidance to maintain long term use or practice of pain coping skills (web-based CBT) increases the likelihood that our proposed intervention is scalable.


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 = -$52,454 )
2026	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Nursing Research	000	1	10/1/2025	NEW	-$52,454
														Subtotal = -$52,454

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Nursing Research	000	1	6/25/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Nursing Research	000	1	9/14/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Nursing Research	000	1	9/2/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Nursing Research	000	1	8/26/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $3,929,419 )
2020	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Nursing Research	000	1	8/14/2020	NEW	$3,929,419
														Subtotal = $3,929,419

Grand Total All Awards = $3,876,965

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Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)

Award Number: UG3NR019196

ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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