Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT05748613

Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's

Led by Florida State University · Updated on 2026-03-05

388

Participants Needed

3

Research Sites

217 weeks

Total Duration

On this page

Sponsors

F

Florida State University

Lead Sponsor

O

Ohio State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to test the effectiveness of a computerized anxiety sensitivity treatment (CAST) compared to a health education control (HEC) in older adults with mild cognitive impairment (MCI) or mild Alzheimer's Disease and related dementias (ADRD) and their care partners. The main questions it aims to answer are: 1. Efficacy of CAST in reducing anxiety and related symptoms among those with MCI/mild ADRD 2. Efficacy of CAST in reducing care partner burden among care partners of people living with MCI/mild ADRD 3. Explore treatment mechanisms using a multi-modal assessment battery of anxiety sensitivity and anxiety Participants will complete six in-person visits including a baseline assessment, two intervention sessions, and three follow-up assessments at 1, 3, and 6-months posttreatment. Participants will also complete three weeks of ecological momentary assessments (EMAs) for one week prior to intervention, one week between intervention sessions, and one week after intervention. If there is a comparison group: Researchers will compare CAST to HEC to see if CAST reduces anxiety and related symptoms in older adults with MCI/mild ADRD and care partner burden to a greater degree than HEC.

CONDITIONS

Official Title

Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient age 60 or older
  • Care partner age 18 or older
  • Has a care partner who will participate (someone who provides emotional or physical support and helps with decision-making)
  • Has access to a smartphone or Wi-Fi
  • Patient scores 20 or above on PROMIS-Anxiety short form OR 5 or above on SSASI OR 31 or above on NIH Toolbox Perceived Stress Scale
  • Patient MoCA score between 17 and 26 OR Memory Complaint Scale score of 3 or greater OR care partner quick dementia rating scale score between 2 and 12.5
Not Eligible

You will not qualify if you...

  • Patient has vision or hearing issues that prevent reading or listening to computer presentations
  • Patient has medical conditions that prevent study participation
  • Patient has severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)
  • Care partner has vision or hearing issues that prevent reading or listening to computer presentations
  • Care partner has medical conditions that prevent study participation
  • Care partner has severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, United States, 32306

Actively Recruiting

2

Ohio University

Athens, Ohio, United States, 45701

Actively Recruiting

3

The Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

N

Norman B Schmidt, Ph.D.

CONTACT

F

Frederick T Schubert, B.A.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's | DecenTrialz