RECRUITING

Treatment of Stress and Anxiety in MCI/Mild ADRD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-02
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05748613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient age 60+
  2. * Care partner 18+
  3. * 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.")
  4. * Score of 22 or above on the PROMIS-Anxiety short form (patient only)
  5. * Score of 5 or above on SSASI (patient only)
  6. * Has smartphone or access to Wi-Fi
  7. 1. Participant MoCA score is between 17 to 26
  8. 2. Participant Memory Complaint Scale score 3 or greater
  9. 3. Care partner quick dementia rating scale score between 2 to 12.5
  1. * Issues with seeing or hearing that would prevent reading or listening to computer presentations
  2. * Medical conditions that would preclude participation in study
  3. * Severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)
  4. * Issues with seeing or hearing that would prevent reading or listening to computer presentations
  5. * Medical conditions that would preclude participation in study
  6. * Severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)

Contacts and Locations

Study Contact

Norman B Schmidt, Ph.D.
CONTACT
8506451766
schmidt@psy.fsu.edu
Frederick T Schubert, B.A.
CONTACT
8045439845
schubert@psy.fsu.edu

Study Locations (Sites)

Anxiety and Behavioral Health Clinic
Tallahassee, Florida, 32306
United States
Ohio University
Athens, Ohio, 45701
United States
The Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Florida State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02
Study Completion Date2028-01

Study Record Updates

Study Start Date2023-11-02
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Anxiety
  • Mild Cognitive Impairment
  • Alzheimer Disease
  • Dementia