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

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.

Participants are dyads consisting of an older adult with MCI/mild ADRD and their care partner. Baseline assessment will include a neuropsychological evaluation to confirm cognitive status for the older adult with MCI/mild ADRD, a series of baseline questionnaires, and introduction to the EMA application. Dyads are randomized to either the CAST or HEC conditions. During CAST sessions, dyads view the CAST presentation and complete interoceptive exposures. An interventionist guides dyads through these sessions. During HEC, dyads view the HEC presentation and complete behavior tracking and goal-setting with the guidance of an interventionist. At both intervention sessions, dyads complete questionnaires including post assessments at the end of intervention session two. For the week prior to intervention session one, the week between the two intervention sessions, and the week after intervention session two, dyads complete daily EMAs about emotional and other factors using an application downloaded on a phone or tablet. At 1, 3, and 6-months follow-up assessments, dyads complete follow-up cognitive testing and outcome questionnaires.

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)