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Randomized Clinical Trial of a Brief, Anxiety Intervention for Mild Cognitive Impairment/mild Alzheimer’s Disease and their Care Providers

Award Number: R01AG077569
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/01/2023
PERIOD OF PERFORMANCE END DATE: 12/31/2027

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Randomized Clinical Trial of a Brief, Anxiety Intervention for Mild Cognitive Impairment/mild Alzheimer’s Disease and their Care Providers - Anxiety psychopathology is highly prevalent in people living with mild cognitive impairment (MCI), Alzheimer's disease and related dementias (ADRD) and their care partners. Recent meta- analyses suggest clinically significant anxiety symptoms in approximately 40% of those with ADRD and approximately 25% in their care partners, as well as increased rates of anxiety in clinical samples of patients with MCI. Moreover, a recent review suggests that elevated anxiety is a marker for and potentially contributes to earlier onset of ADRD symptoms among those with MCI. Despite this, there are no well-established interventions for anxiety in MCI/ADRD or their care partners. Moreover, prior treatment protocols for anxiety are lengthy, excessively rely on intact memory and cognitive abilities, and result in high dropout rates. Brief, mechanism focused interventions offer an efficient, alternative approach to dealing with anxiety in people with MCI/ADRD and their care partners. Anxiety sensitivity (AS) is an extremely well-researched risk mechanism relevant to the genesis and maintenance of anxiety and other forms of psychopathology. AS acts as a broad stress amplification factor as it exacerbates the experience of somatic and emotional sensations, leading to increased distress. As such, individuals with elevated AS are more likely to experience exaggerated responses to a wide array of stressors including cognitive symptoms (e.g., concentration and memory problems). Fortunately, focused interventions have been developed showing that AS can be quickly and effectively reduced. These interventions include psychoeducation but focus heavily on interoceptive exposure (IE) exercises designed to reduce conditioned fear to anxiety-provoking internal stimuli. Across clinical trials, evidence shows such interventions can markedly reduce AS and that these reductions mediate reductions in anxiety symptoms. While AS interventions have been successfully used in a variety of samples, they have not been tested for people with MCI/ADRD. We propose to conduct a fully powered randomized clinical trial (RCT) to test a brief, CBT-based intervention, called cognitive anxiety sensitivity treatment (CAST) for people with MCI/mild AD. We believe the IE component of CAST will be particularly relevant to MCI/mild ADRD where learning may be compromised due to cognitive decline. Moreover, our preliminary data suggest that CAST yields medium to high effect size reductions in AS and anxiety in older adults with MCI. Dyads consisting of MCI/mild AD and their care partners will be randomized to CAST to a Health Education Control (HEC) condition (N = 197) and followed for six months to evaluate change in anxiety and distress, cognitive functioning and quality of life.


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 = $734,833 )
2026	2026	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Aging Research	000	4	2/11/2026	NON-COMPETING CONTINUATION	$661,351
2026	2026	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Aging Research	001	4	2/24/2026	NON-COMPETING CONTINUATION	$73,482
														Subtotal = $734,833

Issue Date FY: 2025 ( Subtotal = $726,840 )
2025	2025	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Aging Research	001	3	7/25/2025	NON-COMPETING CONTINUATION	$59,334
2025	2025	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Aging Research	000	3	1/15/2025	NON-COMPETING CONTINUATION	$667,506
														Subtotal = $726,840

Issue Date FY: 2024 ( Subtotal = $746,255 )
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Aging Research	001	2	5/17/2024	NON-COMPETING CONTINUATION	$74,626
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Aging Research	000	2	2/2/2024	NON-COMPETING CONTINUATION	$671,629
														Subtotal = $746,255

Issue Date FY: 2023 ( Subtotal = $764,501 )
2023	2023	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Aging Research	000	1	12/14/2022	NEW	$764,501
														Subtotal = $764,501

Grand Total All Awards = $2,972,429

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Randomized Clinical Trial of a Brief, Anxiety Intervention for Mild Cognitive Impairment/mild Alzheimer’s Disease and their Care Providers

Award Number: R01AG077569

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/01/2023

PERIOD OF PERFORMANCE END DATE: 12/31/2027

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