NCT03949868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2025

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

May 13, 2019

Last Update Submit

April 16, 2026

Conditions

Keywords

mindfulnessforgetfulnessLangerian mindfulness

Outcome Measures

Primary Outcomes (4)

  • Everyday Memory Questionnaire-Revised (EMQ-R; Royle & Lincoln, 2008)

    This 13-item self-report scale measures subjective memory failures. Namely, respondents are asked to indicate whether or not they had experienced certain memory failures within the past 24 hours (e.g., "Did you find that a word was "on the tip of your tongue" - you knew what it was but could not quite find it?). Following the 13 yes/no questions about one's memory functioning, participants are asked to rate how stressful these failures are on a scale of 0-10 with 0 indicating "not at all stressful" to 10 indicating "very stressful." The final question asks the participant to compare their memory functioning that day compared to other days ("much worse than usual, a little worse than usual, same as usual, somewhat better than usual, much better than usual"). This 13-item version was shortened from the original 28-item version (Sunderland, Watts, Baddeley, \& Harris, 1986).

    2 minutes

  • Memory Controllability Inventory (MCI; Lachman, Bandura, Weaver, & Elliott, 1995)

    The Memory Controllability Inventory is a 19-item Likert scale with questions about one's memory. Participants rate each statement from 1 (strongly disagree) to 7 (strongly agree). The MCI includes six subscales, including: Present Ability (e.g., "I can remember the things I need to."), Potential Improvement (e.g., "I can find ways to improve my memory"), Effort Utility (e.g., "If I work at it, I can improve my memory."), Inevitable Decrement (e.g., "There's not much I can do to keep my memory from going downhill.", Independence (e.g., "As I get older I won't have to rely on others to remember things for me.", and Alzheimer's Likelihood (e.g., I think there's a good chance I will get Alzheimer's disease"). On all the subscales except Alzheimer's Likelihood, higher scores indicate higher levels of perceived personal control over one's memory.

    3 minutes

  • Multifactorial Memory Questionnaire (MMQ; Troyer & Rich, 2002).

    The Multifactorial Memory Questionnaire is a 54-item self-report scale, which asks about overall satisfaction with one's memory ("MMQ-Contentment"), one's perceived memory ability ("MMQ-Ability"), and the extent to which one employs memory strategies ("MMQ-Strategy"). The MMQ-Contentment asks respondents to rate each item on a scale of 1 (strongly agree) to 5 (strongly disagree), with 3 indicating "undecided." An example of the "Contentment" subscale is "I am generally pleased with my memory ability." The MMQ-Ability subscale asks respondents to rate 20 different memory mistakes on a scale of 1 (all the time) to 5 (never). An example of the "Ability" subscale is "Forgot an appointment." The MMQ-Strategy subscale asks respondents to rate how often they used a given memory strategy on a scale of 1 (all the time) to 5 (never). An example of a strategy included in this subscale is, "Use a timer or alarm to remind you when to do something."

    3 minutes

  • Brief Test of Adult Cognition by Telephone with Stop-and-Go Switch Task (BTACT; (Tun & Lachman, 2006)

    The BTACT is a neuropsychological battery based off well-known laboratory tasks and modified versions of well-established psychometric tests. The BTACT, which is proctored over the phone, is designed to be sensitive to performance a range of cognitive abilities in older adults without cognitive impairments including: episodic verbal memory (both immediate and delayed list recall of 15 unrelated words of the Rey Auditory-Verbal Learning Test, Rey, 1964), working memory span (backwards digit span, Wechsler, 1997) and language verbal fluency. We also included the optional Stop-and-Go switch task to test task-switching ability/inhibitory control. Two versions of the test (Form A and Form B) are available for repeated measurement. This test has demonstrated good construct validity and test-retest reliability (Lachman, Agrigoroaei, Tun, \& Weaver, 2014). Moreover, the assessment's authors found no difference in performance between individuals who took the test over the phone vs. in person.

    20 minutes

Secondary Outcomes (4)

  • Langer Mindfulness Scale (LMS-14; Pirson, Langer, Bodner, & Zilcha, 2012)

    2 minutes

  • Positive and Negative Affect Schedule (PANAS; Watson, Clark, & Tellegen, 1988)

    2 minutes

  • Image of Aging Scale (Levy, Kasl, & Gill, 2004).

    2 minutes

  • Subjective Age Measure (Barak & Schiffman, 1981).

    2 minutes

Study Arms (3)

High Mindfulness

EXPERIMENTAL

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.

Behavioral: High Mindfulness

Low Mindfulness

EXPERIMENTAL

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.

Behavioral: Low Mindfulness

Active control

ACTIVE COMPARATOR

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.

Behavioral: Active control

Interventions

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.

High Mindfulness
Low MindfulnessBEHAVIORAL

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.

Low Mindfulness
Active controlBEHAVIORAL

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.

Active control

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not aware of how the conditions differ, nor are they aware of how many conditions there are.
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 14, 2019

Study Start

August 30, 2018

Primary Completion

May 8, 2019

Study Completion

April 10, 2025

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations