Mindful Attention to Variability in Everyday Memory

NCT ID: NCT03949868

Last Updated: 2021-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Memory Lapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

High Mindfulness

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Low Mindfulness

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Active control

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age: 65-80
• An expressed concern or anxiety about memory performance (Responding "YES" when asked if concerned about memory at all)
• Fluent in English
• Owns a smartphone

Exclusion Criteria

• The presence of cognitive impairment (more than 2 incorrect responses) on the Short Portable Mental Status Questionnaire (SPMSQ), an instrument developed to assess cognitive functioning over the phone.
• The presence of any medical conditions that affect cognitive ability, such as stroke, acquired brain injury, dementia, and other neurological disorders or illnesses, or untreated hypertension.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard University

OTHER

Sponsor Role: lead

Responsible Party

Karyn Gunnet-Shoval

Sub-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Harvard University

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

IRB18-0247

Identifier Type: -

Identifier Source: org_study_id