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ACT1VATE: Addressing Emotional Distress to Improve Outcomes among Diverse Adults with Type 1 Diabetes

Award Number: R01DK127491
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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ACT1VATE: Addressing Emotional Distress to Improve Outcomes among Diverse Adults with Type 1 Diabetes - 7. Project Summary/Abstract In 2016, the American Diabetes Association (ADA) released its inaugural Position Statement on Psychosocial Care for People with Diabetes, which identified diabetes self-management education and ongoing support (DSME/S) as the first-line intervention for DD. However, there is no evidence that DSME/S is the appropriate intervention for DD. The proposed RCT will compare DSME + ACT1VATE versus traditional DSME/S (Usual Care; UC) in improving glycemic control among N=484 diverse (~25% Hispanic, 10% Black, 5% Asian), predominantly working age adults with poorly controlled T1D and significant DD. Participants will be recruited from the Scripps Division of Diabetes and Endocrinology – a large clinical endocrine practice whose 13 physician members serve thousands of T1D adults. Capitalizing on existing and real world processes, electronic health records will be used to identify eligible patients and examine primary outcomes. All participants will receive UC, which consists of standard, 1:1 DSME delivered by a Scripps Registered Nurse/Certified Diabetes Care and Education Specialist (RN/CDCES). Thereafter, participants will receive 5 telemedicine group sessions of either 1) T1D support groups with traditional content delivered by an RN/CDCES (i.e., the ongoing support component, “S,” of DSME/S; UC group), or 2) a psychological intervention, directly designed to address DD, to be delivered by a Behavioral Health Provider who is an integrated member of the diabetes care team (ACT1VATE group). The flexible ACT1VATE protocol facilitates tailoring to the (1) participants’ root cause(s) of DD, (2) developmental needs of this predominantly working age adult group; and (3) diverse cultural composition of the patient population, via the sensitive consideration of values and thought patterns/beliefs that influence diabetes self-management. ACT1VATE is grounded in Acceptance and Commitment Therapy (ACT), which has been delivered effectively in clinics via brief format; implemented via phone and other modalities; and adapted for a wide range of chronic conditions. However, only two small studies have examined this approach in diabetes, and neither focused on individuals with DD or integrated the ACT interventionist as a member of the diabetes care team. We predict that DSME + DSME + ACT1VATE will be superior to traditional DSME/S (UC) in improving DD and glycemic control given its (1) specific focus on DD, without any expectation that difficult diabetes-related thoughts and emotions must (or can) be completely eliminated; and (2) purposeful linkage of diabetes self-care behaviors to an individual’s deeply held values, thus eliciting intrinsic, patient-centric motivation for meaningful and lasting health behavior changes. We posit that DD will decrease in ACT1VATE as a by-product of achieving success in managing one’s health and increasing acceptance of difficult diabetes related-thoughts and feelings.


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: 2024 ( Subtotal = $0 )
2024	2023	SCRIPPS HEALTH	4275 CAMPUS POINT CT	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	8/7/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $656,226 )
2023	2023	SCRIPPS HEALTH	10140 CAMPUS POINT DR	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/31/2023	NON-COMPETING CONTINUATION	$656,226
														Subtotal = $656,226

Issue Date FY: 2022 ( Subtotal = $656,226 )
2022	2022	SCRIPPS HEALTH	10140 CAMPUS POINT DR, CPA 415	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	7/25/2022	NON-COMPETING CONTINUATION	$656,226
														Subtotal = $656,226

Issue Date FY: 2021 ( Subtotal = $656,226 )
2021	2021	SCRIPPS HEALTH	10140 CAMPUS POINT DR, CPA 415	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/25/2021	NON-COMPETING CONTINUATION	$656,226
														Subtotal = $656,226

Issue Date FY: 2020 ( Subtotal = $652,778 )
2020	2020	SCRIPPS HEALTH	10140 CAMPUS POINT DR, CPA 415	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/15/2020	NEW	$652,778
														Subtotal = $652,778

Grand Total All Awards = $2,621,456

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ACT1VATE: Addressing Emotional Distress to Improve Outcomes among Diverse Adults with Type 1 Diabetes

Award Number: R01DK127491

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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