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NCT Number: NCT05748613

Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's

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.

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Key information

Conditions

Anxiety Alzheimer Disease Anxiety Disorders Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxiety and Behavioral Health Clinic, Tallahassee, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Participant MoCA score is between 17 to 26

OR

  • Participant Memory Complaint Scale score 3 or greater

OR

  • 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)

Treatment and study plan

Computerized Anxiety Sensitivity Treatment

Behavioral

Brief computerized treatment for anxiety sensitivity

Other names: CAST

Health Education Control

Behavioral

Brief computerized presentation on healthy behaviors

Other names: HEC, Physical Health Education Training ,PHET

Primary outcomes

  1. Change in anxiety sensitivity pre intervention to posttreatment.

    Time frame: 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.

  2. Change in anxiety pre intervention to 1-month follow-up.

    Time frame: 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 outcomes

  1. Change in negative affect pre intervention to 1-month follow-up.

    Time frame: 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.

  2. Change in stress pre intervention to 1-month follow-up.

    Time frame: 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.

  3. Change in quality of life pre intervention to 1-month follow-up.

    Time frame: 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.

  4. Change in depression pre intervention to 1-month follow-up.

    Time frame: 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.

  5. Change in cognitive functioning pre intervention to 1-month follow-up.

    Time frame: 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.

  6. Stability of anxiety sensitivity from posttreatment to 6-month follow-up.

    Time frame: 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.

  7. Stability of anxiety from 1-month follow-up to 6-month follow-up.

    Time frame: 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.

  8. Stability of depression from 1-month follow-up to 6-month follow-up.

    Time frame: 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.

  9. Stability of negative affect from 1-month follow-up to 6-month follow-up.

    Time frame: 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.

  10. Stability of stress from 1-month follow-up to 6-month follow-up.

    Time frame: 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.

  11. Stability of quality of life from 1-month follow-up to 6-month follow-up.

    Time frame: 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.

  12. Stability of cognitive functioning from 1-month follow-up to 6-month follow-up.

    Time frame: 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.

  13. Change in care partner burden from pre intervention to 1-month follow-up.

    Time frame: 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.

  14. Change in objective measure of interoceptive fear conditioning pre to posttreatment

    Time frame: 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.

  15. Change in Loneliness from pre intervention to 1-month follow up

    Time frame: Baseline through Month 1 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frederick T Schubert, B.A.

CONTACT

[email protected]

8045439845

Norman B Schmidt, Ph.D.

CONTACT

[email protected]

8506451766

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Ohio State University
  • Ohio University

Registry information

Official study title

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

Acronym: ASTRA

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 1, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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