Episodic Memory Integration and Interference

July 26, 2023 updated by: Boston College

A Basic Science Study on Episodic Memory Integration and Interference in Healthy Adults

The purpose of this study is to assess how emotional memories integrate and interfere with one another over time. We will be using a multi-session experimental paradigm consisting of two encoding sessions and one retrieval session. Participants will either complete these sessions online or in-person, with the latter collecting functional magnetic resonance imaging during the two encoding sessions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being informed about the study, all participants giving written informed consent will complete three experimental sessions. On Day 1, participants will encode AB neutral word pairs (e.g., Pencil - Car) shown alongside positive, negative, or neutral images. Participants will also rate the images on valence and arousal. After encoding all stimuli, participants will immediately complete a retrieval task, during which they will be presented with the cue word (A; e.g., Pencil) and asked to recall the corresponding associate (B, e.g., Car). If incorrect, the correct word pair will be shown before the next trial. The complete list of word pairs will be shown until at least 90% of the word associates are recalled. On Day 2 (~24 h later), participants will return to encode new AC word pairs, where one of the words is the same from the first encoding session and one is different (e.g., Pencil - Book). These AC words pairs will be encoded alongside new images that either match the valence of the first session or shift to a different valence. Again, participants will rate the valence and arousal of each image and complete a subsequent memory test until they reach 90% accuracy on all word pairs. On Day 3, participants will complete the final session of the study, during which they will be shown a cue word (e.g., Pencil) and asked to freely recall the corresponding associates from days 1 and 2 (e.g., Car and Book). Participants will also be asked to remember the day each word associate was originally shown and the valence of the paired image from that day. 100 participants will complete these sessions and their corresponding behavioral tasks online (e.g., via Prolific). An additional 50 participants will complete these sessions in-person, and functional magnetic resonance imaging will be collected during Day 1 and Day 2 to examine how the blood oxygen-level dependent (BOLD) signal is modulated by task conditions. Psychophysiological data such as respiration and heart rate may also be collected. All participants (online and fMRI) will provide individual difference metrics on mood and well-being, including the Beck Depression Inventory, State-Trait Anxiety Inventory, NEO Personality Inventory, and Ruminative Responses Scale. On each day prior to the start of the experimental task, participants will also complete the Profile of Mood States, Positive and Negative Affect Scale, the Pittsburgh Sleep Quality Index, and sleep logs for the night before to index the amount and quality of sleep.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. All participants: willing and able to follow the protocol
  2. All participants: fluent in English
  3. Online participants: online account in the crowdsourcing platform that will be used (e.g., Prolific)

Exclusion Criteria:

  1. All participants: history of a psychiatric or neurological condition, and/or current psychotropic drug use (indicated by the participant)
  2. fMRI participants: pregnant, metal in body (incl piercings or metallic makeup if unwilling to remove), unable to lie still for duration of scan (e.g., due to pain), Meniere's disease, claustrophobic, or other contraindication for MRI as determined my MRI technician, left-handed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Emotional memory updating paradigm
All participants will encode AB/AC word pairs shown with images that have differing emotional valence (positive, negative, or neutral)
Other: emotional context similarity
On Day 1, all participants will encode AB neutral word pairs (e.g., Pencil - Car) shown with positive, negative, or neutral images. On Day 2, all participants will encode AC neutral words pairs (e.g., Pencil - Book) alongside images of either the same or different valence. The emotional similarity of AB (Day 1) and AC (Day 2) image contexts (i.e., the independent variable) will consist of the following conditions: positive-positive, positive-negative, negative-negative, negative-positive, neutral-neutral, neutral-positive, and neutral-negative.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Memory for the Associated Words
Time Frame: Day 3
During the memory recall task on Day 3, participants will be shown a cue word (A) and asked to recall the corresponding associates from Day 1 (B) and Day 2 (C) by typing their response in a blank text field. Participants will also report their confidence in these memories from 1 (not at all confident) to 9 (extremely confident).
Day 3
fMRI Measured Neural Reactivity (Blood Oxygen-Level Dependent Signal)
Time Frame: Day 2
fMRI data from Day 1 and Day 2 will be used to perform whole-brain analyses of neural response during encoding, as well as compute neural pattern similarity scores between AB and AC pairs from same- or differently-valenced contexts. Our primary hypothesis is that the similarity of neural patterns in the dorsomedial prefrontal cortex will predict memory performance on Day 3.
Day 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Source Memory
Time Frame: Day 3
During the memory recall task on Day 3, participants will also be asked to report which day each paired associate (B & C) was shown by selecting "1", "2", or "?" if unsure. Additionally, participants will indicate the valence of the image that they remember being associated with each pair from 1 (very negative) to 9 (very positive), as well as their confidence in the remembered valence from 1 (not at all confident) to 9 (extremely confident).
Day 3
Change in Resting-State Functional Connectivity
Time Frame: Day 2
Prior work from our lab has shown that increased amygdala-visuosensory connectivity after encoding predicts a memory bias for negatively-valenced stimuli, whereas increased amygdala-prefrontal connectivity predicts a memory bias for positively-valenced stimuli. In the current study, we will also examine whether changes in functional connectivity of the amygdala on Day 2 predict individual differences in memory performance on Day 3 (change = post - pre connectivity strength).
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MH134570

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication.

IPD Sharing Time Frame

De-identified data will be available for access and sharing as soon as the final version of the manuscript is accepted for publication

IPD Sharing Access Criteria

Because data will be de-identified, these data will be posted on an open access website.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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