Evidence map›Paper›PMID 40774425›Full record

ArticleContemporary clinical trials2025

Study design and protocol for cognitive anxiety sensitivity treatment for anxiety in adults with mild cognitive impairment or dementia.

Abigail E Markley, Kayley M Stratton, Grace Y Cho, Norman B Schmidt, Julie Suhr, Julia L Sheffler, Christopher Nguyen, Frederick T Schubert, Jaime R G Quiles, Miracle R Potter and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05748613 (Treatment of Stress and Anxiety in Mild Cognitive Impairment/Mild Alzheimer's Disease and Related Dementias - RCT), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05748613 narecruitingnot on this map

Treatment of Stress and Anxiety in Mild Cognitive Impairment/Mild Alzheimer's Disease and Related Dementias - RCT

TypeinterventionalSponsorFlorida State UniversityRan2023 to 2028Enrolled388ConditionsAnxiety, Mild Cognitive Impairment, Alzheimer Disease, DementiaArmsComputerized Anxiety Sensitivity Treatment, Health Education Control
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Abigail E MarkleyDepartment of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA.
Kayley M StrattonDepartment of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA.
Grace Y ChoDepartment of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA.
Norman B SchmidtDepartment of Psychology, Florida State University, Tallahassee, FL, USA.
Julie SuhrDepartment of Psychology, Ohio University-Department of Psychology, Athens, OH, USA.
Julia L ShefflerDepartment of Psychology, Florida State University, Tallahassee, FL, USA.
Christopher NguyenDepartment of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA.
Frederick T SchubertDepartment of Psychology, Florida State University, Tallahassee, FL, USA.
Jaime R G QuilesDepartment of Psychology, Florida State University, Tallahassee, FL, USA.
Miracle R PotterDepartment of Psychology, Florida State University, Tallahassee, FL, USA.
Melissa A MeynadasyDepartment of Psychology, Florida State University, Tallahassee, FL, USA.
Sarah Millisor IrvinDepartment of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA.
Nicholas P AllanDepartment of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA. Electronic address: Nicholas.allan@osumc.edu.

Funding

Randomized Clinical Trial of a Brief, Anxiety Intervention for Mild Cognitive Impairment/mild Alzheimer’s Disease and their Care ProvidersR01AG077569 · NIA · FLORIDA STATE UNIVERSITY · PI Nicholas Paul Allan, NORMAN BRAD SCHMIDT · 2023 to 2026
$3.0M
NIA NIH HHS R01 AG077569
6 · The paper itself

Abstract

backgroundAnxiety is prevalent among older adults with mild cognitive impairment (MCI) and mild Alzheimer's disease and related disorders (ADRD) and may contribute to accelerated cognitive decline and increased care partner burden. Computerized Anxiety Sensitivity Treatment (CAST) is a novel, CBT-based intervention targeting anxiety sensitivity, which has not been widely tested in this population.

methodsThis randomized controlled trial (NCT05748613) will compare CAST to a health education control (HEC) in 194 dyads consisting of older adults with MCI/mild ADRD and their care partners. Primary outcomes include reductions in anxiety sensitivity and anxiety symptoms. Secondary outcomes include measures of mental health and well-being symptoms, improved cognitive performance, and decreased care partner burden. Participants will be assessed at baseline, during two intervention sessions, and follow-ups at 1-, 3-, and 6-months post-intervention. EXPECTED OUTCOMES: CAST will significantly lower anxiety sensitivity (AS) post-intervention and reduce anxiety compared to HEC. Secondary hypotheses propose that CAST will reduce other mental symptoms and improve cognitive functioning more effectively than HEC. Additionally, CAST will alleviate care partner distress and improve their quality of life compared to HEC, with the secondary hypothesis suggesting that these effects will be mediated by reductions in AS in older adults. Furthermore, reductions in AS from pre- to post-intervention will account for the effect of CAST on anxiety, and the secondary hypothesis suggesting that reductions in interoceptive fear conditioning will also contribute to the observed anxiety reduction. CLINICALTRIALS: gov registration: #NCT05748613.

Indexed as

Alzheimer DiseaseAnxietyCaregiversCognitive Behavioral TherapyCognitive DysfunctionDementiaAgedFemaleHumansMaleQuality of LifeRandomized Controlled Trials as TopicTherapy, Computer-AssistedAnxietyCare partnerComputerized interventionDementiaMild cognitive impairment

Identifiers

PMID40774425
PMCPMC13673564

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.