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Clinical Trials/NCT04821960
NCT04821960
Completed
Not Applicable

Improving Emotional Well-being and Quality of Life in Older Adults Experiencing Dementia-related Fear.

Northwestern University1 site in 1 country81 target enrollmentMay 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety and Fear
Sponsor
Northwestern University
Enrollment
81
Locations
1
Primary Endpoint
Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study is a randomized control study to determine the impact of a tailored, web-based mindfulness program to reduce anxiety and increase the quality of life in older adults experiencing dementia-related fears, relative to a conventional meditation program.

Detailed Description

The study will test two different types of online mindfulness programs to see if an online self-paced mindfulness program can help reduce anxiety related to memory loss. Participants will be involved in the study for a total of 10 weeks. Participants will log on to an online mindfulness program 4 days per week for about 10-20 minutes each. The total program will last 3 weeks. Participants will also be asked to complete questionnaires before starting the program, during the program, and after they complete the program.

Registry
clinicaltrials.gov
Start Date
May 17, 2021
End Date
December 31, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 55 years of age or older
  • Elevated dementia-related fear
  • Able to read/write in English
  • Willingness to be randomized to intervention group
  • Willingness to complete three weeks of self-guided intervention, questionnaires, and cognitive tests.
  • Access to a reliable internet connection

Exclusion Criteria

  • Diagnosis of mild cognitive impairment, Alzheimer's Disease, or dementia by a healthcare provider.
  • Impaired cognitive or neurologic function
  • Unstable medical condition
  • Severe depression
  • Current treatment for anxiety or depression
  • Current participation in another psychotherapy
  • Current use of psychiatric medication
  • Current substance use disorder
  • Inadequate vision or hearing to interact with study materials

Outcomes

Primary Outcomes

Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up

Time Frame: 10 Weeks Post-Baseline

A 24-item scale to assess fear of memory loss. Scores range from 24-120 points with a higher score indicating a higher fear of memory loss.

Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up

Time Frame: 10 Weeks Post-Baseline

A 30-item scale to assess fear of Alzheimer's disease. Minimum score = 0; maximum score = 120. A higher score indicates a greater fear of developing Alzheimer's Disease.

Secondary Outcomes

  • Memory Failure Scale (MFS)(10 Week Post-Baseline)

Study Sites (1)

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