Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
388 (estimated)
Sponsor
Florida State University · Other
Who this trial is looking for
This trial is looking for older adults with mild Alzheimer's or mild cognitive impairment and their care partners. Participants will attend in-person visits and complete assessments to see if the treatment helps with anxiety.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 60 years old.
I have a care partner who can join the study.
I have a smartphone or access to Wi-Fi.
I score 20 or more on the PROMIS-Anxiety short form or meet other anxiety criteria.
I have a MoCA score between 17 and 26 or meet other cognitive criteria.
You may not be able to join if
I have severe issues with seeing or hearing that prevent me from participating.
I have medical conditions that would prevent me from joining the study.
I have severe mental illness like schizophrenia or unmedicated bipolar disorder.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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 clos…
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)
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