Treatment of Stress and Anxiety in MCI/Mild ADRD
Purpose
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.
Conditions
- Anxiety
- Mild Cognitive Impairment
- Alzheimer Disease
- Dementia
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.") - Score of 22 or above on the PROMIS-Anxiety short form (patient only) - Score of 5 or above on SSASI (patient only) - Has smartphone or access to Wi-Fi 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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Variable-sized permuted block randomization will be used to allocate participants to treatment condition, stratified by dementia severity (MCI vs. mild ADRD) and gender.
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- An independent assessor (blind to treatment condition) will conduct pre-intervention and follow-up assessments. The assessor will have extensive training and experience in conducting the relevant assessments including clinical interviews and neuropsychological evaluations. A separate interventionist will assist in the delivery of the intervention.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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Experimental Computerized Anxiety Sensitivity Treatment |
CAST is a transdiagnostic cognitive behavioral therapy (CBT)-based protocol designed to address elevated anxiety sensitivity (AS), particularly the amplification of cognitive stress symptoms including perceived confusion and memory problems. CAST is a fully computerized, 1-hour intervention containing video animation and audio narration throughout, as well as interactive features (e.g., brief quizzes to promote comprehension, introduction and practice with interoceptive exposures). Procedures draw heavily on standard CBT techniques; AS, a core vulnerability for anxiety and depression is targeted using these procedures. In CAST, participants are informed that "the primary purpose of the presentation is to highlight healthier, more productive, and effective ways of dealing with stress." Through participation in the intervention, people learn adaptive long-term strategies for tolerating, coping with, and effectively reducing distress and negative emotions. |
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Placebo Comparator Health Education Control |
HEC is a fully computerized 1-hour control condition focused on increasing healthy behaviors and decreasing unhealthy behaviors. Content includes healthy eating, hydration, sleep and rest, exercise, stress management as well as other healthy lifestyle tips. To match the interactive components in the CAST condition, behavior tracking and goal-setting are included in HEC. The HEC protocol has been used in prior studies as a control condition for CAST to account for intervention modality and time. HEC is perceived positively, with high rates of acceptability. Importantly, HEC is inert with respect to the proposed mechanism of action (AS). |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Florida State University
Detailed Description
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.
