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Computerized Anxiety Treatment for Mild Alzheimer's Disease

N/A

Recruiting

Research Sponsored by Florida State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-month to 6-month follow-up

Summary

This trial tests if a computerized anxiety treatment can reduce symptoms in older adults with mild cognitive impairment or mild Alzheimer's and their care partners. #medical #clinicaltrial

Who is the study for?

This trial is for pairs of older adults (60+) with mild cognitive impairment or early Alzheimer's and their care partners (18+). Participants must have a certain level of anxiety, be able to use a smartphone or Wi-Fi, and not suffer from severe mental illness or medical conditions that would interfere with the study. Care partners should provide support and help with decision-making.

What is being tested?

The trial tests if computerized anxiety sensitivity treatment (CAST) is more effective than health education control (HEC) in reducing anxiety symptoms in patients and easing the burden on their care partners. It includes baseline assessments, intervention sessions, follow-ups at 1, 3, and 6 months post-treatment, plus weekly ecological momentary assessments.

What are the potential side effects?

Since this trial involves non-pharmaceutical interventions like CAST and HEC programs focused on education and therapy via computer presentations, side effects are minimal but may include discomfort due to discussing personal issues related to anxiety or stress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-month to 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-month to 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month to 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Change in anxiety sensitivity pre intervention to posttreatment.

Secondary study objectives

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

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

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

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Computerized Anxiety Sensitivity TreatmentExperimental Treatment1 Intervention

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.

Group II: Health Education ControlPlacebo Group1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computerized Anxiety Sensitivity Treatment

2019

N/A

~40

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