Forgetfulness is a common complaint among middle and older adults, with the vast majority of these complaints not rooted in established causes or diagnoses. The contents of these subjective cognitive complaints (SCC) include difficulty retrieving specific words (e.g., names of people or places), misplacing common items (e.g., keys or eyeglasses), and prospective memory failures (e.g., forgetting appointments and reasons for entering a room). One study found that 54% of people in a sample composed of 15,000 adults over the age of 55 reported that they had some difficulty remembering things over the past year. In the subsample composed of individuals aged 85+, this figure increased to 62%.
While some experiences of forgetting can be partially explained by age-related cognitive decline, problems with retrieval processes can be attributed to a host of other factors including stress and anxiety, lack of sleep, and side effects from medications. Even with all of these other possible aspects at play, older adults tend to attribute everyday instances of forgetting to uncontrollable factors including age. Moreover, while society tends to associate forgetting with the elderly population, young adults also report the experience of forgetting. There is reason to suspect that while older adults tend to experience more instances of forgetting than they did as younger adults, they also pay more attention to instances of forgetting, gathering evidence that they are declining. Every instance of forgetting can confirm that one is in the midst of decline. This process is a type of confirmation bias: Every time an older adult notices an instance of forgetting, he/she confirms that the self fits within the larger negative age stereotype. The present study investigates the Attention to Variability Paradigm. Specifically the participants will pay attention to how memory performance fluctuates throughout the day. Primary outcomes will be memory efficacy beliefs and memory performance on a telephone task.
Condition or disease | Intervention/treatment | Phase |
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Memory Lapse | Behavioral: High Mindfulness Behavioral: Low Mindfulness Behavioral: Active control | Not Applicable |
In the present study, the participants will be assigned to one of three groups: an active control group, a group asked to attend to everyday memory performance, and a group asked to notice variability in their everyday memory performance. The researchers hypothesize that the experimental groups will improve on memory outcomes more than those in the control group as a result of participation. The researchers hypothesize that when older adults are trained over 6 days to notice variability in memory ability the participants will report having more control over memory abilities then will the participants in the other two groups. The researchers also expect that the participants will show more improvement on a memory task than the participants in the other groups.
The researchers will take measurements of memory efficacy beliefs and memory performance at 2 timepoints (T0=baseline, T1= immediately after the 6 days of text messages). All surveys will be collected online via the Qualtrics.com platform.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Participant) |
Masking Description: | Participants are not aware of how the conditions differ, nor are they aware of how many conditions there are. |
Primary Purpose: | Basic Science |
Official Title: | Mindful Attention to Variability in Everyday Memory |
Actual Study Start Date : | August 30, 2018 |
Estimated Primary Completion Date : | December 31, 2019 |
Estimated Study Completion Date : | December 31, 2019 |
Arm | Intervention/treatment |
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Experimental: High Mindfulness
All participants in this condition will complete all measures online and over the phone at two points in time, including one narrative response at T1. They will also be instructed to complete a mindfulness intervention at home and respond to diary-type text messaging questions (all including questions about memory performance) twice daily for six days.
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Behavioral: High Mindfulness
Those in the "high mindfulness" group will also receive questions about their memory performance over the past 30 minutes in both the morning and evening for six days. In order to emphasize the variability in pain, participants will receive these text messages on a variable schedule. In addition, they will sent instructions every morning to pay attention to variability in their memory performance throughout the day and asked to report on how their memory performance is changing over time as a part of each text message prompt.
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Experimental: Low Mindfulness
All participants in this condition will complete all measures online and over the phone at two points in time, including one narrative response at T1. They will also be instructed to respond to diary-type text messaging questions (some related to memory performance) twice daily for six days.
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Behavioral: Low Mindfulness
Those in the "low mindfulness" group, who will receive receive two text messages per day (one at at 9am and one at 8pm) for six days, each prompting them to write about the activity they are currently engaged in. They will also be prompted with the 9am text to report on their memory performance over the past 30 minutes.
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Active Comparator: Active control
All participants in this condition will complete all measures online and over the phone at two points in time, including one narrative response at T1. They will also be instructed to respond to diary-type text messaging questions (none about memory performance) twice daily for six days.
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Behavioral: Active control
Participants in the "active control" group will receive 2 text messages per day for six days (one at 9am and one at 8pm) asking them to report on the activity they are currently engaged in.
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Ages Eligible for Study: | 65 Years to 80 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
United States, Massachusetts | |
Harvard University | |
Cambridge, Massachusetts, United States, 02138 |
Tracking Information | |||||
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First Submitted Date ICMJE | May 13, 2019 | ||||
First Posted Date ICMJE | May 14, 2019 | ||||
Last Update Posted Date | September 11, 2019 | ||||
Actual Study Start Date ICMJE | August 30, 2018 | ||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Mindful Attention to Variability in Everyday Memory | ||||
Official Title ICMJE | Mindful Attention to Variability in Everyday Memory | ||||
Brief Summary |
Forgetfulness is a common complaint among middle and older adults, with the vast majority of these complaints not rooted in established causes or diagnoses. The contents of these subjective cognitive complaints (SCC) include difficulty retrieving specific words (e.g., names of people or places), misplacing common items (e.g., keys or eyeglasses), and prospective memory failures (e.g., forgetting appointments and reasons for entering a room). One study found that 54% of people in a sample composed of 15,000 adults over the age of 55 reported that they had some difficulty remembering things over the past year. In the subsample composed of individuals aged 85+, this figure increased to 62%. While some experiences of forgetting can be partially explained by age-related cognitive decline, problems with retrieval processes can be attributed to a host of other factors including stress and anxiety, lack of sleep, and side effects from medications. Even with all of these other possible aspects at play, older adults tend to attribute everyday instances of forgetting to uncontrollable factors including age. Moreover, while society tends to associate forgetting with the elderly population, young adults also report the experience of forgetting. There is reason to suspect that while older adults tend to experience more instances of forgetting than they did as younger adults, they also pay more attention to instances of forgetting, gathering evidence that they are declining. Every instance of forgetting can confirm that one is in the midst of decline. This process is a type of confirmation bias: Every time an older adult notices an instance of forgetting, he/she confirms that the self fits within the larger negative age stereotype. The present study investigates the Attention to Variability Paradigm. Specifically the participants will pay attention to how memory performance fluctuates throughout the day. Primary outcomes will be memory efficacy beliefs and memory performance on a telephone task. |
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Detailed Description |
In the present study, the participants will be assigned to one of three groups: an active control group, a group asked to attend to everyday memory performance, and a group asked to notice variability in their everyday memory performance. The researchers hypothesize that the experimental groups will improve on memory outcomes more than those in the control group as a result of participation. The researchers hypothesize that when older adults are trained over 6 days to notice variability in memory ability the participants will report having more control over memory abilities then will the participants in the other two groups. The researchers also expect that the participants will show more improvement on a memory task than the participants in the other groups. The researchers will take measurements of memory efficacy beliefs and memory performance at 2 timepoints (T0=baseline, T1= immediately after the 6 days of text messages). All surveys will be collected online via the Qualtrics.com platform. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single (Participant) Masking Description: Participants are not aware of how the conditions differ, nor are they aware of how many conditions there are. Primary Purpose: Basic Science
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Condition ICMJE | Memory Lapse | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
210 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2019 | ||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 65 Years to 80 Years (Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03949868 | ||||
Other Study ID Numbers ICMJE | IRB18-0247 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Karyn Gunnet-Shoval, Harvard University | ||||
Study Sponsor ICMJE | Harvard University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Harvard University | ||||
Verification Date | September 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |