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Completed

NCT Number: NCT04821960

Memory and Fear Study (Fear of Memory Loss Study)

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.

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Key information

Conditions

Anxiety and Fear Anxiety Disorders Mental Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored Mindfulness Program for Fear of Memory Loss

Behavioral

The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.

Other names: Conventional Mindfulness Program

Conventional Mindfulness Program

Behavioral

Routine non-tailored mindfulness lessons and activities.

Primary outcomes

  1. 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.

  2. 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

  1. Memory Failure Scale (MFS)

    Time frame: 10 Week Post-Baseline

    A 12-item scale that measures memory failure that people tend to experience in everyday life. Minimum score=12; maximum score= 60. A higher score indicates a greater likelihood of memory failures.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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