NCT05748613Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 388 (estimated)
- First submitted
- 7 Feb 2023
- Start date
- 2 Nov 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- Florida State University
- Diseases
- Alzheimer disease
- NCT number
- NCT05748613
What you commit to
- Study type: Interventional
- Planned participants: 388
- From 2 Nov 2023 to the primary completion date, Jun 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Medical conditions that would preclude participation in study
- Severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)
- CARE PARTNER
- Medical conditions that would preclude participation in study
- Severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)
Other
- PATIENT
- Issues with seeing or hearing that would prevent reading or listening to computer presentations
- Issues with seeing or hearing that would prevent reading or listening to computer presentations
Who the study is looking for
- 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
- Participant MoCA score is between 17 to 26
- OR
- Participant Memory Complaint Scale score 3 or greater
- OR
- Care partner quick dementia rating scale score between 2 to 12.5
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio University Coordinator of this site? Confirm its status | Athens | United States | Recruiting |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Anxiety and Behavioral Health Clinic Coordinator of this site? Confirm its status | Tallahassee | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.