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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in anxiety pre intervention to 1-month follow-up.
Change in anxiety sensitivity pre intervention to posttreatment.
Secondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Florida State UniversityLead Sponsor
200 Previous Clinical Trials
31,370 Total Patients Enrolled
Ohio UniversityOTHER
69 Previous Clinical Trials
36,826 Total Patients Enrolled
Ohio State UniversityOTHER
830 Previous Clinical Trials
505,232 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My care partner is 18 years old or older.I am 60 years old or older.My care partner has no health issues preventing them from participating.
Research Study Groups:
This trial has the following groups:- Group 1: Computerized Anxiety Sensitivity Treatment
- Group 2: Health Education Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are engaging in this experiment?
"Correct. The medical trial is still open for enrollment, as evidenced by the most recent update that was made to its listing on clinicaltrials.gov on June 30th 2023. Currently, 388 participants are being sought from 3 different medical centres which first advertised this research study back in June 1st of 2021."
Answered by AI
Is there any availability for volunteers to take part in this research?
"Per the information on clinicaltrials.gov, this medical trial is currently looking for individuals to participate in their research. The study was first publicized on June 1st of 2023 and underwent its most recent modification at the end of that month."
Answered by AI
What primary goals are being sought with this clinical experimentation?
"This clinical trial's primary outcome will be observed over a period of one month, measuring any shifts in anxiety sensitivity before and after treatment. Secondary outcomes include changes to depression levels (assessed via the PROMIS - Depression Short Form 8b), stability of negative affect from 1-month follow up to 6 months follow up (measured using PANAS-NA) and alterations in stress pre intervention and post intervention (evaluated with NIH Toolbox - Perceived Stress)."
Answered by AI
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