NCT05748613 Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's
| NCT ID | NCT05748613 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida State University |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 388 participants |
| Start Date | 2023-11-02 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 388 participants in total. It began in 2023-11-02 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05748613 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05748613 currently recruiting?
Yes, NCT05748613 is actively recruiting participants. Contact the research team at schmidt@psy.fsu.edu for enrollment information.
Where is the NCT05748613 trial being conducted?
This trial is being conducted at Tallahassee, United States, Athens, United States, Columbus, United States.
Who is sponsoring the NCT05748613 clinical trial?
NCT05748613 is sponsored by Florida State University. The trial plans to enroll 388 participants.
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