Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's

NCT05748613 | Recruiting DMC

• 1 other identifier: STUDY00003432
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 3

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:

1. 1.Efficacy of CAST in reducing anxiety and related symptoms among those with MCI/mild ADRD
2. 2.Efficacy of CAST in reducing care partner burden among care partners of people living with MCI/mild ADRD
3. 3.Explore treatment mechanisms using a multi-modal assessment battery of anxiety sensitivity and anxiety

Conditions

Alzheimer Disease; Dementia; Anxiety; Mild Cognitive Impairment

Keywords

Computerized Intervention; Brief Treatment; Psychoeducation; Interoceptive Exposure; Older Adults; Care Partner; Anxiety Sensitivity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to 1-month follow-up

Secondary Outcomes (15)

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

  Baseline to 1-month follow-up

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

  Baseline to 1-month follow-up

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

  Baseline to 1-month follow-up

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

  Baseline to 1-month follow-up

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

  Baseline to 1-month follow-up

Study Arms (2)

Computerized Anxiety Sensitivity Treatment

EXPERIMENTAL

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

Health Education Control

PLACEBO COMPARATOR

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

Interventions

Health Education Control BEHAVIORAL

Brief computerized presentation on healthy behaviors

Also known as: HEC, Physical Health Education Training ,PHET

Health Education Control

Computerized Anxiety Sensitivity Treatment BEHAVIORAL

Brief computerized treatment for anxiety sensitivity

Also known as: CAST

Computerized Anxiety Sensitivity Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Participant Memory Complaint Scale score 3 or greater
• Care partner quick dementia rating scale score between 2 to 12.5

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida State University: lead
• Ohio State University: collaborator
• Ohio University: collaborator

Study Sites (3)

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32306, United States

RECRUITING

Ohio University

Athens, Ohio, 45701, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (20)

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  PMID: 40774425 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Cognitive Dysfunction; Alzheimer Disease; Dementia

Interventions

NDC80 protein, human

Condition Hierarchy (Ancestors)

Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Central Study Contacts

Norman B Schmidt, Ph.D.

CONTACT

8506451766; schmidt@psy.fsu.edu

Frederick T Schubert, B.A.

CONTACT

8045439845; schubert@psy.fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Distinguished Research Professor, Department Chair

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

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 1, 2023
• Study Start: November 2, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)