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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
388
Brief computerized treatment for anxiety sensitivity
Brief computerized presentation on healthy behaviors
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, United States
RECRUITINGOhio University
Athens, Ohio, United States
RECRUITINGThe Ohio State University
Columbus, Ohio, United States
RECRUITINGChange in anxiety sensitivity pre intervention to posttreatment.
Anxiety sensitivity will be measured using the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 is an 18-item self report measure with possible scores ranging from 0 to 72. Higher scores indicate higher anxiety sensitivity.
Time frame: Baseline to immediately after the intervention
Change in anxiety pre intervention to 1-month follow-up.
Anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS Anxiety) Short Form 8a self-report measure. The PROMIS Anxiety is an 8-item self report questionnaire with possible scores ranging from 8 to 40. Higher scores indicate more anxiety.
Time frame: Baseline to 1-month follow-up
Change in negative affect pre intervention to 1-month follow-up.
Negative affect will be assessed using the Positive and Negative Affect Schedule - Negative Affect (PANAS-NA). PANAS-NA is a 10-item self-report measure with possible scores ranging from 10 to 50. Higher scores indicate more negative affect.
Time frame: Baseline to 1-month follow-up
Change in stress pre intervention to 1-month follow-up.
Stress will be assessed with the NIH Toolbox - Perceived Stress. The NIH Toolbox - Perceived Stress is a 10-item self-report measure with possible scores ranging from 10 to 50. Higher scores indicate more stress.
Time frame: Baseline to 1-month follow-up
Change in quality of life pre intervention to 1-month follow-up.
Quality of life will be assessed with the NIH Toolbox General Life Satisfaction scale. The NIH Toolbox General Life Satisfaction scale is a 5-item self-report measure with possible scores ranging from 5 to 35. Higher scores indicate higher life satisfaction.
Time frame: Baseline to 1-month follow-up
Change in depression pre intervention to 1-month follow-up.
Depression will be assessed using the PROMIS - Depression Short Form 8b. The PROMIS - Depression is an 8-item self-report measure with possible scores ranging from 8 to 40. Higher scores indicate higher level of depression.
Time frame: Baseline to 1-month follow-up
Change in cognitive functioning pre intervention to 1-month follow-up.
Cognitive functioning will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS assesses cognitive functioning in the following domains: immediate memory, visuospatial functioning, attention, language, and delayed memory.
Time frame: Baseline to 1-month follow-up
Stability of anxiety sensitivity from posttreatment to 6-month follow-up.
Anxiety sensitivity will be measured using the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 is an 18-item self report measure with possible scores ranging from 0 to 72. Higher scores indicate higher anxiety sensitivity.
Time frame: Immediately after the intervention to 6-month follow-up.
Stability of anxiety from 1-month follow-up to 6-month follow-up.
Anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS Anxiety) Short Form 8a self-report measure. The PROMIS Anxiety is an 8-item self report questionnaire with possible scores ranging from 8 to 40. Higher scores indicate more anxiety.
Time frame: 1-month to 6-month follow-up
Stability of depression from 1-month follow-up to 6-month follow-up.
Depression will be assessed using the PROMIS - Depression Short Form 8b. The PROMIS - Depression is an 8-item self-report measure with possible scores ranging from 8 to 40. Higher scores indicate higher level of depression.
Time frame: 1-month to 6-month follow-up
Stability of negative affect from 1-month follow-up to 6-month follow-up.
Negative affect will be assessed using the Positive and Negative Affect Schedule - Negative Affect (PANAS-NA). PANAS-NA is a 10-item self-report measure with possible scores ranging from 10 to 50. Higher scores indicate more negative affect.
Time frame: 1-month to 6-month follow-up
Stability of stress from 1-month follow-up to 6-month follow-up.
Stress will be assessed with the NIH Toolbox - Perceived Stress. The NIH Toolbox - Perceived Stress is a 10-item self-report measure with possible scores ranging from 10 to 50. Higher scores indicate more stress.
Time frame: 1-month to 6-month follow-up
Stability of quality of life from 1-month follow-up to 6-month follow-up.
Quality of life will be assessed with the NIH Toolbox General Life Satisfaction scale. The NIH Toolbox General Life Satisfaction scale is a 5-item self-report measure with possible scores ranging from 5 to 35. Higher scores indicate higher life satisfaction.
Time frame: 1-month to 6-month follow-up
Stability of cognitive functioning from 1-month follow-up to 6-month follow-up.
Cognitive functioning will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS assesses cognitive functioning in the following domains: immediate memory, visuospatial functioning, attention, language, and delayed memory.
Time frame: 1-month to 6-month follow-up
Change in care partner burden from pre intervention to 1-month follow-up.
Care partner burden will be assessed using the Zarit Burden Interview - Short. The Zarit Burden Interview - Short is a 12-item self-report questionnaire with a possible score range of 0 to 48. Higher scores indicate higher burden levels.
Time frame: Baseline to 1-month follow-up
Change in objective measure of interoceptive fear conditioning pre to posttreatment
Interoceptive fear conditioning will be assessed with a skin conductance response (SCR) during an interoceptive exposure. Higher SCR numbers indicate higher interoceptive fear.
Time frame: Baseline to immediately after the intervention
Change in Loneliness from pre intervention to 1-month follow up
Loneliness will be measured using the 10-item UCLA Loneliness Short form questionnaire. This self-report scale yields scores between 10 to 40 with higher scores indicating more significant loneliness symptoms.
Time frame: Baseline through Month 1 follow up
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