RecruitingNot ApplicableNCT05748613

Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's

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


Sponsor

Florida State University

Enrollment

388 participants

Start Date

Nov 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an online intervention designed to reduce anxiety in people with Alzheimer's disease or early memory loss, along with their care partners (family members or close friends). The program helps participants understand and manage their fear of anxiety symptoms. **You may be eligible if...** - The patient is 60 years or older and has a care partner aged 18 or older who will participate - Both have access to a smartphone or Wi-Fi - The patient has significant anxiety or stress symptoms (as measured by standardized questionnaires) - There are signs of memory impairment or early cognitive decline based on cognitive screening scores or care partner reports **You may NOT be eligible if...** - The patient has severe vision or hearing problems that prevent using a computer - The patient has a serious mental illness such as schizophrenia or unmedicated bipolar disorder - The care partner has a medical condition preventing their participation, or a serious mental illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALComputerized Anxiety Sensitivity Treatment

Brief computerized treatment for anxiety sensitivity

BEHAVIORALHealth Education Control

Brief computerized presentation on healthy behaviors


Locations(3)

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, United States

Ohio University

Athens, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

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NCT05748613


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