Treatment of Stress and Anxiety in Mild Cognitive Impairment/Mild Alzheimer's Disease and Related Dementias - RCT

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

‣ 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

⁃ OR

⁃ Participant Memory Complaint Scale score 3 or greater

⁃ OR

⁃ Care partner quick dementia rating scale score between 2 to 12.5

Locations
United States
Florida
Anxiety and Behavioral Health Clinic
RECRUITING
Tallahassee
Ohio
Ohio University
RECRUITING
Athens
The Ohio State University
RECRUITING
Columbus
Contact Information
Primary
Norman B Schmidt, Ph.D.
schmidt@psy.fsu.edu
8506451766
Backup
Frederick T Schubert, B.A.
schubert@psy.fsu.edu
8045439845
Time Frame
Start Date: 2023-11-02
Estimated Completion Date: 2028-01
Participants
Target number of participants: 388
Treatments
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).
Related Therapeutic Areas
Sponsors
Collaborators: Ohio University, Ohio State University
Leads: Florida State University

This content was sourced from clinicaltrials.gov