Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT05748613
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computerized Anxiety Sensitivity Treatment — BEHAVIORAL
    Brief computerized treatment for anxiety sensitivity
  • Health Education Control — BEHAVIORAL
    Brief computerized presentation on healthy behaviors

Study Details

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.

Key Dates

Start date
Nov 2, 2023
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
388 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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).

Primary Outcome Measure

Change in anxiety sensitivity pre intervention to posttreatment. [ Time Frame: Baseline to immediately after the intervention ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Anxiety and Behavioral Health ClinicTallahasseeFlorida32306
Norman B. Schmidt, Ph.D. (PRINCIPAL_INVESTIGATOR)
Ohio UniversityAthensOhio45701
Nik Allan, PhD
The Ohio State UniversityColumbusOhio43210
Nik Allan, PhD

Find similar trials in Tallahassee, FL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Anxiety and Behavioral Health Clinic· Tallahassee, FLOhio University· Athens, OHThe Ohio State University· Columbus, OH

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