Memory and Fear Study (Fear of Memory Loss Study)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety and Fear

Intervention / Treatment
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* Behavioral: Tailored Mindfulness Program for Fear of Memory Loss
* Behavioral: Conventional Mindfulness Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Mindfulness Program<br>Routine mindfulness lessons and activities. | Behavioral: Conventional Mindfulness Program<br>* Routine non-tailored mindfulness lessons and activities.<br>|
| Experimental: Tailored Mindfulness Program for Fear of Memory Loss<br>Tailored mindfulness lessons and activities for fear of memory loss. | Behavioral: Tailored Mindfulness Program for Fear of Memory Loss<br>* The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.<br>* Other names: Conventional Mindfulness Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of 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 | 
| Change of 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Patient Reported Outcome Measures Information System-29 (PROMIS-29) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Fear of memory loss