AzTrials
AzTrials

AnxietyASTRANCT05748613

Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's

A study testing Computerized Anxiety Sensitivity Treatment in people with Anxiety and Mild Cognitive Impairment, run by Florida State University at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Computerized Anxiety Sensitivity Treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
388 participants
Where
3 sitesUnited States
Study dates
2 Nov 2023to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Norman B Schmidt, Ph.D. contact

8506451766

schmidt@psy.fsu.edu

Frederick T Schubert, B.A. contact

8045439845

schubert@psy.fsu.edu

United States3 sites, 3 recruiting

  • Ohio University

    Athens, Ohio, 45701

    Nik Allan, PhD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Nik Allan, PhD

    Recruiting

  • Anxiety and Behavioral Health Clinic

    Tallahassee, Florida, 32306

    Norman B. Schmidt, Ph.D.

    Recruiting

Other trials in United States

About this study

Official title: 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
Read more

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.

Read the 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.

Being tested
Computerized Anxiety Sensitivity Treatment, Health Education Control
Keywords
Computerized Intervention, Brief Treatment, Psychoeducation, Interoceptive Exposure, Older Adults, Care Partner, Anxiety Sensitivity
Medical subject headings
Anxiety Disorders, Cognitive Dysfunction, Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computerized Anxiety Sensitivity TreatmentBehavioural

    Also called CAST

    Brief computerized treatment for anxiety sensitivity

  • Health Education ControlBehavioural

    Also called HEC, Physical Health Education Training ,PHET

    Brief computerized presentation on healthy behaviors

Study groups in NCT05748613
Study groupRoleWhat they receive
Computerized Anxiety Sensitivity TreatmentExperimentalCAST 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.
Receives: Behavioral: Computerized Anxiety Sensitivity Treatment
Health Education ControlPlacebo comparatorHEC 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).
Receives: Behavioral: Health Education Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change 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.

    Measured: Baseline to immediately after the intervention

  2. 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.

    Measured: Baseline to 1-month follow-up

Secondary outcomes (15)

  1. 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.

    Measured: Baseline to 1-month follow-up

  2. 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.

    Measured: Baseline to 1-month follow-up

  3. 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.

    Measured: Baseline to 1-month follow-up

  4. 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.

    Measured: Baseline to 1-month follow-up

  5. 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.

    Measured: Baseline to 1-month follow-up

  6. 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.

    Measured: Immediately after the intervention to 6-month follow-up.

  7. 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.

    Measured: 1-month to 6-month follow-up

  8. 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.

    Measured: 1-month to 6-month follow-up

  9. 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.

    Measured: 1-month to 6-month follow-up

  10. 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.

    Measured: 1-month to 6-month follow-up

  11. 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.

    Measured: 1-month to 6-month follow-up

  12. 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.

    Measured: 1-month to 6-month follow-up

  13. 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.

    Measured: Baseline to 1-month follow-up

  14. 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.

    Measured: Baseline to immediately after the intervention

  15. 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.

    Measured: Baseline through Month 1 follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2023
  2. Study start2 Nov 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
388 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05748613
Sponsor's protocol ID
STUDY00003432
Acronym
ASTRA
Status last verified
Mar 2026
First submitted
7 Feb 2023
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan

Publications

  • Zvolensky MJ, Garey L, Fergus TA, Gallagher MW, Viana AG, Shepherd JM, Mayorga NA, Kelley LP, Griggs JO, Schmidt NB. Refinement of anxiety sensitivity measurement: The Short Scale Anxiety Sensitivity Index (SSASI). Psychiatry Res. 2018 Nov;269:549-557. doi: 10.1016/j.psychres.2018.08.115. Epub 2018 Aug 29.

    PubMed 30199696

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019

  • Vale FAC, Balieiro AP Jr, Silva-Filho JH. Memory complaint scale (MCS). Proposed tool for active systematic search. Dement Neuropsychol. 2012 Oct-Dec;6(4):212-218. doi: 10.1590/S1980-57642012DN06040004.

    PubMed 29213800

  • Galvin JE. THE QUICK DEMENTIA RATING SYSTEM (QDRS): A RAPID DEMENTIA STAGING TOOL. Alzheimers Dement (Amst). 2015 Jun 1;1(2):249-259. doi: 10.1016/j.dadm.2015.03.003.

    PubMed 26140284

  • Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823.

    PubMed 9845158

  • Delis, D. C., Kaplan, E., & Kramer, J. H. (2001). Delis-Kaplan Executive Function System (D-KEFS) [Database record]. APA PsycTests.

  • Wechsler, D. (2008). Wechsler Adult Intelligence Scale--Fourth Edition (WAIS-IV) [Database record]. APA PsycTests.

  • Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

    PubMed 9881538

  • Taylor S, Zvolensky MJ, Cox BJ, Deacon B, Heimberg RG, Ledley DR, Abramowitz JS, Holaway RM, Sandin B, Stewart SH, Coles M, Eng W, Daly ES, Arrindell WA, Bouvard M, Cardenas SJ. Robust dimensions of anxiety sensitivity: development and initial validation of the Anxiety Sensitivity Index-3. Psychol Assess. 2007 Jun;19(2):176-88. doi: 10.1037/1040-3590.19.2.176.

    PubMed 17563199

  • Kupst MJ, Butt Z, Stoney CM, Griffith JW, Salsman JM, Folkman S, Cella D. Assessment of stress and self-efficacy for the NIH Toolbox for Neurological and Behavioral Function. Anxiety Stress Coping. 2015;28(5):531-44. doi: 10.1080/10615806.2014.994204. Epub 2015 Feb 10.

    PubMed 25577948

  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PubMed 3397865

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • Craig, C., Marshall, A., Sjostrom, M., Bauman, A., Lee, P., Macfarlane, D., ... & Stewart, S. (2017). International physical activity questionnaire-short form. J Am Coll Health, 65(7), 492-501.

  • Zarit, S., Orr, N. K., & Zarit, J. M. (1985). The hidden victims of Alzheimer's disease: Families under stress. NYU press.

  • Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.

    PubMed 9153155

Questions about this trial

What is this clinical trial studying?

A study testing Computerized Anxiety Sensitivity Treatment in people with Anxiety and Mild Cognitive Impairment, run by Florida State University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Norman B Schmidt, Ph.D. (8506451766, schmidt@psy.fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in anxiety sensitivity pre intervention to posttreatment. (time frame: Baseline to immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05748613, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in