What is the Anxiety Sensitivity Treatment studying for mild cognitive impairment and Alzheimer's disease?

This study is evaluating whether a computerized therapy called CAST can reduce anxiety and related symptoms in older adults with mild cognitive impairment or mild Alzheimer's disease and help reduce burden for their care partners. It compares CAST to a health education program. The research is sponsored by Florida State University and aims to better support these individuals and their families.

Who may be eligible for this mild cognitive impairment and Alzheimer's clinical trial?

Adults aged 60 or older with mild cognitive impairment or mild Alzheimer's disease who have a care partner aged 18 or older may be eligible. Participants must have certain levels of anxiety or stress and access to a smartphone or Wi-Fi. Care partners must be able to participate as well. Please review eligibility criteria for more details.

Is there any cost to participate in this mild cognitive impairment and Alzheimer's clinical trial?

Study-related care, including the study therapy and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase Not Applicable

Age: 60Years +

All Genders

ID05748613

Testing Computerized Anxiety Sensitivity Treatment to Reduce Anxiety in Older Adults with Mild Cognitive Impairment or Mild Alzheimers and Their Care Partners

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

388

Participants Needed

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a computerized Anxiety Sensitivity Treatment CAST compared to a health education control HEC in older adults aged 60 and above with mild cognitive impairment MCI or mild Alzheimers Disease and related dementias ADRD, along with their care partners. The study aims to see if CAST can reduce anxiety and related symptoms in these individuals and lessen the burden on their care partners. It also explores treatment mechanisms using a detailed assessment of anxiety sensitivity and anxiety. Participants join as pairs, each consisting of an older adult with MCImild ADRD and their care partner. After a baseline assessment which includes neuropsychological testing, dyads are randomly assigned to either CAST or HEC. CAST involves two 1-hour sessions of a computerized cognitive behavioral therapy protocol focused on reducing anxiety sensitivity, including interactive features and guided interoceptive exposures. HEC, also computerized and lasting 1 hour, provides education on healthy behaviors with behavior tracking and goal-setting. Both groups complete questionnaires during intervention sessions and ecological momentary assessments EMAs for three separate weeks around the interventions. Participants attend six in-person visits baseline, two intervention sessions, and three follow-ups at 1, 3, and 6 months after treatment. During these visits, they complete cognitive tests and questionnaires. Daily EMAs collected through a smartphone or tablet app track emotional and other factors before, during, and after the interventions. Researchers measure changes in anxiety sensitivity and anxiety from baseline through follow-up, along with care partner burden and other mental health outcomes. The total study duration includes these assessments and monitoring over six months post-intervention.

CONDITIONS

Brief Title

Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's

Who Can Participate

Age: 60Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient aged 60 years or older
Care partner aged 18 years or older
Has a care partner 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 to 26 OR Memory Complaint Scale score 3 or greater OR Care partner quick dementia rating scale score between 2 to 12.5

You will not qualify if you...

Patient has vision or hearing problems preventing reading or listening to computer presentations
Patient has medical conditions that prevent participation
Patient has severe mental illness such as schizophrenia or unmedicated bipolar disorder
Care partner has vision or hearing problems preventing reading or listening to computer presentations
Care partner has medical conditions that prevent participation
Care partner has severe mental illness such as schizophrenia or unmedicated bipolar disorder

Research Team

Norman B Schmidt, Ph.D.

Frederick T Schubert, B.A.

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Testing Computerized Anxiety Sensitivity Treatment to Reduce Anxiety in Older Adults with Mild Cognitive Impairment or Mild Alzheimers and Their Care Partners

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria