Memory and Fear Study (Fear of Memory Loss Study)

Anxiety and Fear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821960
• Other study ID #: STU00214078
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 31, 2022
• Est. primary completion date: June 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety and Fear
• Memory Disorders

Intervention

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.
• Conventional Mindfulness Program
Routine non-tailored mindfulness lessons and activities.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up	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
Primary	Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up	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	Memory Failure Scale (MFS)	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