Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's
NCT ID: NCT05748613
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
388 participants
INTERVENTIONAL
2023-11-02
2028-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Computerized Anxiety Sensitivity Treatment
Brief computerized treatment for anxiety sensitivity
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).
Health Education Control
Brief computerized presentation on healthy behaviors
Interventions
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Computerized Anxiety Sensitivity Treatment
Brief computerized treatment for anxiety sensitivity
Health Education Control
Brief computerized presentation on healthy behaviors
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
* 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)
60 Years
ALL
No
Sponsors
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Ohio State University
OTHER
Ohio University
OTHER
Florida State University
OTHER
Responsible Party
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Norman Schmidt
Ph.D., Distinguished Research Professor, Department Chair
Locations
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Anxiety and Behavioral Health Clinic
Tallahassee, Florida, United States
Ohio University
Athens, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Nik Allan, PhD
Role: primary
Nik Allan, PhD
Role: primary
References
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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.
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.
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Markley AE, Stratton KM, Cho GY, Schmidt NB, Suhr J, Sheffler JL, Nguyen C, Schubert FT, Quiles JRG, Potter MR, Meynadasy MA, Irvin SM, Allan NP. Study design and protocol for cognitive anxiety sensitivity treatment for anxiety in adults with mild cognitive impairment or dementia. Contemp Clin Trials. 2025 Sep;156:108044. doi: 10.1016/j.cct.2025.108044. Epub 2025 Aug 6.
Other Identifiers
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STUDY00003432
Identifier Type: -
Identifier Source: org_study_id
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