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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Mindfulness Program | Active Comparator | Routine mindfulness lessons and activities. |
|
| Tailored Mindfulness Program for Fear of Memory Loss | Experimental | Tailored mindfulness lessons and activities for fear of memory loss. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38030988 | Derived | Farina FR, Regan J, Marquez M, An H, O'Loughlin P, Pavithra P, Taddeo M, Knight RC, Bennett M, Lenaert B, Griffith JW. Reducing fear and avoidance of memory loss improves mood and social engagement in community-based older adults: a randomized trial. BMC Geriatr. 2023 Nov 29;23(1):786. doi: 10.1186/s12877-023-04470-4. | |
| 34328428 |
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De-identified data may be shared with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Mindfulness Program | Routine mindfulness lessons and activities. Conventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities. |
| FG001 | Tailored Mindfulness Program for Fear of Memory Loss | Tailored mindfulness lessons and activities for fear of memory loss. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Mindfulness Program | Routine mindfulness lessons and activities. Conventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities. |
| BG001 | Tailored Mindfulness Program for Fear of Memory Loss |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 10 Weeks Post-Baseline |
|
Data were collected over a 10 week period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Mindfulness Program | Routine mindfulness lessons and activities. Conventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James W. Griffith | Northwestern University | 3125035345 | j-griffith@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2021 | Mar 1, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2022 | Jun 22, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2021 | Mar 1, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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|
| Conventional Mindfulness Program | Behavioral | Routine non-tailored mindfulness lessons and activities. |
|
| O'Loughlin P, Pavithra P, Regan J, Bennett M, Knight R, Lenaert B, Marquez M, Taddeo M, Griffith J, Shapiro R, Farina F. A Randomized Controlled Trial Investigating the Feasibility of a Low-Intensity Psychological Intervention for Fear of Memory Loss and Quality of Life in Older Adults: Protocol for the Reducing Fear and Avoidance of Memory Loss (REFRAME) Study. JMIR Res Protoc. 2021 Jul 30;10(7):e30514. doi: 10.2196/30514. |
Tailored mindfulness lessons and activities for fear of memory loss.
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 10 Week Post-Baseline |
|
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|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Tailored Mindfulness Program for Fear of Memory Loss | Tailored mindfulness lessons and activities for fear of memory loss. 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. | 0 | 40 | 0 | 40 | 0 | 40 |
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