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
Who can join
Ages 60 and older · All sexes
Full eligibility 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)About the study
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.
What is being tested
- Computerized Anxiety Sensitivity Treatment (behavioral)
- Health Education Control (behavioral)
Sponsor: Florida State University · Participants: 388 · Started: Nov 2, 2023
Contact the study team
- Norman B Schmidt, Ph.D. · Phone: 8506451766
- Frederick T Schubert, B.A. · Phone: 8045439845
Official record on ClinicalTrials.gov — NCT05748613
Locations in the U.S.
| Florida | Anxiety and Behavioral Health Clinic, Tallahassee |
| Ohio | Ohio University, Athens The Ohio State University, Columbus |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.