Memory and Fear Study (Fear of Memory Loss Study)

March 16, 2023 updated by: James W Griffith, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

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.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Mindfulness Program
Routine mindfulness lessons and activities.
Behavioral: Conventional Mindfulness Program
Routine non-tailored mindfulness lessons and activities.
Experimental: Tailored Mindfulness Program for Fear of Memory Loss
Tailored mindfulness lessons and activities for fear of memory loss.
Behavioral: Tailored Mindfulness Program for Fear of Memory Loss
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of 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.
10 Weeks Post-Baseline
Change of 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.
10 Weeks Post-Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 Week Post-Baseline
Patient Reported Outcome Measures Information System-29 (PROMIS-29)
Time Frame: 10 Weeks Post-Baseline
A 29-item scale to assess quality of life, social functioning, fatigue, anxiety, and depression. Each item has 5 answer options (from 1 to 5). From the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in each domain score between 4 and 20.
10 Weeks Post-Baseline
World Health Organization Well-Being Index (WHO-5)
Time Frame: 10 Weeks Post-Baseline
A 5-item scale to assess overall well-being. Minimum raw score = 0; maximum raw score = 25. Raw scores are multiplied by 4 to give a final score from 0 (representing the worst well-being) to 100 (representing the best well-being).
10 Weeks Post-Baseline
Patient Global Impression of Change (PGIC)
Time Frame: Follow-up (4 weeks)
To assess participant's impression of change in their fear and anxiety since the start of the intervention. This scale is 1-item. Minimum score = 1; maximum score = 5. A higher score indicates the best change since starting the intervention.
Follow-up (4 weeks)
Coronavirus Anxiety Scale (CAS)
Time Frame: 10 Weeks Post-Baseline
A 5-item self-report mental health screener of dysfunctional anxiety associated with the coronavirus crisis. This scale is 5-items. Minimum score = 0; maximum score = 20. A higher score indicates higher dysfunctional coronavirus-related anxiety.
10 Weeks Post-Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Actual)

June 29, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00214078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified data may be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety and Fear

Clinical Trials on Conventional Mindfulness Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe