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A Fully Remote Pilot Randomized Controlled Trial to Investigate the Impact of Insomnia Treatment on Crohn’s disease

Award Number: K23DK134814
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 02/15/2023
PERIOD OF PERFORMANCE END DATE: 11/30/2027

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A Fully Remote Pilot Randomized Controlled Trial to Investigate the Impact of Insomnia Treatment on Crohn’s disease - PROJECT SUMMARY Poor sleep is common in people with Crohn’s disease (CD) and predicts greater likelihood of symptom flares, surgery, hospitalization, and reduced quality of life. Insomnia disorder – chronic difficulty with initiating or maintaining sleep – is the most common sleep disorder in this population. It is also associated with increases in both chronic pain and inflammation. While insomnia in this population may initially develop due to CD flares, our preliminary data indicate that people with CD and insomnia report insomnia-related behaviors and are interested in treatment for their sleep problems. Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended first-line treatment for insomnia disorder. It is highly effective not only for treating insomnia, but also for improving pain and inflammation. However, while effectiveness of CBT-I has been demonstrated in other populations, nighttime bowel movements and the hypervigilance that results from fear of fecal incontinence are unique to Crohn’s, highlighting the importance of investigation in this population. In this K23 project, the applicant will conduct a pilot randomized controlled trial of CBT-I adapted for CD vs control in 60 adults with CD and insomnia. Using a mixed-methods approach, she will investigate: 1) the feasibility and acceptability of CBT-I in CD; 2) the impact of CBT-I on insomnia, sleep patterns, CD symptoms, and inflammation; and 3) treatment response subgroups and barriers and facilitators to intervention engagement. This research is expected to advance our understanding of the sleep/CD relationship and possible treatment options for a significant problem affecting this population. To support the applicant’s career development, training goals, and proposed research project, she has assembled an exceptional mentorship team that brings expertise in CD pathophysiology, assessment, and management (Dr. Corey Siegel), objective sleep assessment and CBT-I (Dr. Michael Smith), mixed-methods research (Dr. Kelly Aschbrenner), behavioral clinical trials in IBD (Dr. Laurie Keefer), and longitudinal methods and data analysis (Dr. Tor Tosteson). The applicant’s training will involve a combination of didactic and practical experiences, conferences, and use of the excellent research infrastructure supported by Dartmouth- Hitchcock Health and the Geisel School of Medicine at Dartmouth. This comprehensive program of training and research will prepare her to compete for NIH R01 funding to evaluate the effectiveness of CBT-I compared to control in a larger, fully powered randomized controlled trial.


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 = $186,225 )
2026	2026	DARTMOUTH-HITCHCOCK CLINIC	1 MEDICAL CENTER DR	LEBANON	NH	03756	GRAFTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	12/5/2025	NON-COMPETING CONTINUATION	$186,225
														Subtotal = $186,225

Issue Date FY: 2025 ( Subtotal = $188,024 )
2025	2025	DARTMOUTH-HITCHCOCK CLINIC	1 MEDICAL CENTER DR	LEBANON	NH	03756	GRAFTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	11/13/2024	NON-COMPETING CONTINUATION	$188,024
														Subtotal = $188,024

Issue Date FY: 2024 ( Subtotal = $188,797 )
2024	2024	DARTMOUTH-HITCHCOCK CLINIC	ONE MEDICAL CENTER DR	LEBANON	NH	03756	GRAFTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	11/28/2023	NON-COMPETING CONTINUATION	$188,797
														Subtotal = $188,797

Issue Date FY: 2023 ( Subtotal = $190,034 )
2023	2023	DARTMOUTH-HITCHCOCK CLINIC	ONE MEDICAL CENTER DR	LEBANON	NH	03756	GRAFTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/15/2023	NEW	$190,034
														Subtotal = $190,034

Grand Total All Awards = $753,080

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A Fully Remote Pilot Randomized Controlled Trial to Investigate the Impact of Insomnia Treatment on Crohn’s disease

Award Number: K23DK134814

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 02/15/2023

PERIOD OF PERFORMANCE END DATE: 11/30/2027

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