Treatment of Stress and Anxiety in MCI/Mild ADRD

Sponsor

Florida State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05748613

Collaborator

Ohio State University (Other), Ohio University (Other)

388

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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:

Efficacy of CAST in reducing anxiety and related symptoms among those with MCI/mild ADRD
Efficacy of CAST in reducing care partner burden among care partners of people living with MCI/mild ADRD
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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Mild Cognitive Impairment Alzheimer Disease Dementia	Behavioral: Computerized Anxiety Sensitivity Treatment Behavioral: Health Education Control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

388 participants

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.Variable-sized permuted block randomization will be used to allocate participants to treatment condition, stratified by dementia severity (MCI vs. mild ADRD) and gender.

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2027

Anticipated Study Completion Date :

Jan 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Computerized Anxiety Sensitivity Treatment Brief computerized treatment for anxiety sensitivity Other Names: CAST
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).	Behavioral: Health Education Control Brief computerized presentation on healthy behaviors Other Names: HEC, Physical Health Education Training ,PHET

Arm

Intervention/Treatment

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.

Behavioral: Computerized Anxiety Sensitivity Treatment

Brief computerized treatment for anxiety sensitivity

Other Names:

CAST

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).

Behavioral: Health Education Control

Brief computerized presentation on healthy behaviors

Other Names:

HEC, Physical Health Education Training ,PHET

Outcome Measures

Primary Outcome Measures

Change in anxiety sensitivity pre intervention to posttreatment. [Baseline to immediately after the intervention]
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.
Change in anxiety pre intervention to 1-month follow-up. [Baseline 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.

Secondary Outcome Measures

Change in negative affect pre intervention to 1-month follow-up. [Baseline 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.
Change in stress pre intervention to 1-month follow-up. [Baseline 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.
Change in quality of life pre intervention to 1-month follow-up. [Baseline 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.
Change in depression pre intervention to 1-month follow-up. [Baseline 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.
Change in cognitive functioning pre intervention to 1-month follow-up. [Baseline 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.
Stability of anxiety sensitivity from posttreatment to 6-month follow-up. [Immediately after the intervention 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.
Stability of anxiety from 1-month follow-up to 6-month follow-up. [1-month 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.
Stability of depression from 1-month follow-up to 6-month follow-up. [1-month 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.
Stability of negative affect from 1-month follow-up to 6-month follow-up. [1-month 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.
Stability of stress from 1-month follow-up to 6-month follow-up. [1-month 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.
Stability of quality of life from 1-month follow-up to 6-month follow-up. [1-month 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.
Stability of cognitive functioning from 1-month follow-up to 6-month follow-up. [1-month 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.
Change in care partner burden from pre intervention to 1-month follow-up. [Baseline 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.
Change in objective measure of interoceptive fear conditioning pre to posttreatment [Baseline to immediately after the intervention]
Interoceptive fear conditioning will be assessed with a skin conductance response (SCR) during an interoceptive exposure. Higher SCR numbers indicate higher interoceptive fear.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Participant MoCA score is between 17 to 26

Participant Memory Complaint Scale score 3 or greater

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)