Treatment for anxiety in older adults with mild Alzheimer's
Official title: Treatment of Stress and Anxiety in Mild Cognitive Impairment/Mild Alzheimer's Disease and Related Dementias - RCT
Run by Florida State University · NCT05748613 · Data updated 2026-11-12
This study is testing a new computer-based treatment for anxiety to see if it helps older adults with mild Alzheimer's feel less anxious and makes it easier for their caregivers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 388 (estimated) |
| Sponsor | Florida State University Academic / other |
| Locations | 3 sites (Tallahassee, Florida and 2 other locations) |
| Status | Recruiting |
| Started | November 2, 2023 |
| Main results expected | June 2027 |
| Study ends | January 2028 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT05748613 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include older adults aged 60 and above with mild cognitive impairment or mild Alzheimer's Disease who have a supportive care partner.
✕Probably not a fit
Patients with severe visual or hearing impairments that prevent them from engaging with the computerized presentations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial tests the effectiveness of a computerized anxiety sensitivity treatment (CAST) compared to a health education control (HEC) for older adults with mild cognitive impairment or mild Alzheimer's Disease and their care partners. Participants will undergo a series of assessments and interventions over six in-person visits, including neuropsychological evaluations and ecological momentary assessments. The study aims to reduce anxiety symptoms in patients and alleviate care partner burden through guided sessions and follow-up evaluations.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce anxiety symptoms in older adults with cognitive impairments and improve the well-being of their care partners.
How similar studies have gone: Other studies have shown promise in using computerized interventions for anxiety, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
DYAD
* Patient age 60+
* Care partner 18+
* Has care partner who will participate ("someone you have a reciprocal relationship with who provides you with emotional or physical support and helps with decision-making. This could be a spouse or significant other, relative, or close friend whom you spend a significant amount of time with.")
* Has smartphone or access to Wi-Fi
EITHER
* Score of 20 or above on the PROMIS-Anxiety short form (patient only) OR
* Score of 5 or above on SSASI (patient only) OR
* Score of 31 or above on NIH Toolbox Perceived Stress Scale score (patient only)
AND EITHER
1. Participant MoCA score is between 17 to 26
OR
2. Participant Memory Complaint Scale score 3 or greater
OR
3. Care partner quick dementia rating scale score between 2 to 12.5
Exclusion Criteria:
PATIENT
* Issues with seeing or hearing that would prevent reading or listening to computer presentations
* Medical conditions that would preclude participation in study
* Severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)
CARE PARTNER
* Issues with seeing or hearing that would prevent reading or listening to computer presentations
* Medical conditions that would preclude participation in study
* Severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)
Where it's running
-
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, United States Recruiting -
Ohio University
Athens, Ohio, United States Recruiting -
The Ohio State University
Columbus, Ohio, United States Recruiting
Study contacts
- Study coordinator: Norman B Schmidt, Ph.D.
- Email: schmidt@psy.fsu.edu
- Phone: 8506451766
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.