Anxiety and Fear
Conditions
Keywords
Mindfulness, Fear of memory loss
Brief 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.
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.
Interventions
BEHAVIORALTailored 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.
BEHAVIORALConventional Mindfulness Program
Routine non-tailored mindfulness lessons and activities.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up | 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. |
| Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up | 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
| Measure | Time frame | Description |
|---|---|---|
| Memory Failure Scale (MFS) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Mindfulness Program Routine mindfulness lessons and activities.
Conventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities. | 41 |
| 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. | 40 |
| Total | 81 |
Baseline characteristics
| Characteristic | Conventional Mindfulness Program | Tailored Mindfulness Program for Fear of Memory Loss | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 12 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 28 Participants | 48 Participants |
| Age, Continuous | 63.7 years | 67 years | 65.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 39 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 32 Participants | 71 Participants |
| Region of Enrollment United States | 41 participants | 10 participants | 81 participants |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 40 |
| other Total, other adverse events | 0 / 41 | 0 / 40 |
| serious Total, serious adverse events | 0 / 41 | 0 / 40 |
Outcome results
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.
Time frame: 10 Weeks Post-Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mindfulness Program | Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up | 63.9 score on a scale | Standard Deviation 11.3 |
| Tailored Mindfulness Program for Fear of Memory Loss | Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up | 60.3 score on a scale | Standard Deviation 10.6 |
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.
Time frame: 10 Weeks Post-Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mindfulness Program | Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up | 47.3 score on a scale | Standard Deviation 20.7 |
| Tailored Mindfulness Program for Fear of Memory Loss | Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up | 45.2 score on a scale | Standard Deviation 20 |
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.
Time frame: 10 Week Post-Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Mindfulness Program | Memory Failure Scale (MFS) | 34.9 score on a scale | Standard Deviation 7.7 |
| Tailored Mindfulness Program for Fear of Memory Loss | Memory Failure Scale (MFS) | 32.2 score on a scale | Standard Deviation 8.5 |