NCT05748613 · Florida State University
Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's
(ASTRA)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Computerized Anxiety Sensitivity Treatment
Brief computerized treatment for anxiety sensitivity
BEHAVIORAL
Health Education Control
Brief computerized presentation on healthy behaviors
Primary outcome measures
Change in anxiety sensitivity pre intervention to posttreatment.
Time frame: Baseline to immediately after the intervention
Anxiety sensitivity will be measured using the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 is an 18-item self report measure with possible scores ranging from 0 to 72. Higher scores indicate higher anxiety sensitivity.
Change in anxiety pre intervention to 1-month follow-up.
Time frame: Baseline to 1-month follow-up
Anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS Anxiety) Short Form 8a self-report measure. The PROMIS Anxiety is an 8-item self report questionnaire with possible scores ranging from 8 to 40. Higher scores indicate more anxiety.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Tallahassee, Florida
- Athens, Ohio
- Columbus, Ohio
Collaborators
Ohio State University, Ohio University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations