Treatment for anxiety in older adults with mild Alzheimer's

Treatment of Stress and Anxiety in Mild Cognitive Impairment/Mild Alzheimer's Disease and Related Dementias - RCT

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

• Phase: NA
• Study type: Interventional
• Enrollment: 388 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Florida State University (other)
• Locations: 3 sites (Tallahassee, Florida and 2 other locations)
• Trial ID: NCT05748613 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Other studies have shown promise in using computerized interventions for anxiety, suggesting potential success for this approach.

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)

Where this trial is running

Tallahassee, Florida and 2 other locations

• 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.

Conditions: Anxiety, Mild Cognitive Impairment, Alzheimer Disease, Dementia, Computerized Intervention, Brief Treatment, Psychoeducation, Interoceptive Exposure