Trial Outcomes & Findings for Memory and Fear Study (Fear of Memory Loss Study) (NCT NCT04821960)
NCT ID: NCT04821960
Last Updated: 2024-05-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
10 Weeks Post-Baseline
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
Conventional Mindfulness Program
Routine mindfulness lessons and activities.
Conventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
|
Overall Study
COMPLETED
|
36
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Memory and Fear Study (Fear of Memory Loss Study)
Baseline characteristics by cohort
| Measure |
Conventional Mindfulness Program
n=41 Participants
Routine mindfulness lessons and activities.
Conventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.
|
Tailored Mindfulness Program for Fear of Memory Loss
n=40 Participants
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.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
63.7 years
n=5 Participants
|
67 years
n=7 Participants
|
65.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
10 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 Weeks Post-BaselineA 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.
Outcome measures
| Measure |
Conventional Mindfulness Program
n=33 Participants
Routine mindfulness lessons and activities.
Conventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.
|
Tailored Mindfulness Program for Fear of Memory Loss
n=25 Participants
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.
|
|---|---|---|
|
Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up
|
63.9 score on a scale
Standard Deviation 11.3
|
60.3 score on a scale
Standard Deviation 10.6
|
PRIMARY outcome
Timeframe: 10 Weeks Post-BaselineA 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.
Outcome measures
| Measure |
Conventional Mindfulness Program
n=40 Participants
Routine mindfulness lessons and activities.
Conventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.
|
Tailored Mindfulness Program for Fear of Memory Loss
n=33 Participants
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.
|
|---|---|---|
|
Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up
|
47.3 score on a scale
Standard Deviation 20.7
|
45.2 score on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 10 Week Post-BaselineA 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.
Outcome measures
| Measure |
Conventional Mindfulness Program
n=40 Participants
Routine mindfulness lessons and activities.
Conventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.
|
Tailored Mindfulness Program for Fear of Memory Loss
n=33 Participants
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.
|
|---|---|---|
|
Memory Failure Scale (MFS)
|
34.9 score on a scale
Standard Deviation 7.7
|
32.2 score on a scale
Standard Deviation 8.5
|
Adverse Events
Conventional Mindfulness Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tailored Mindfulness Program for Fear of Memory Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place