- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974371
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
150
Phase
- 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
- Name: Erin Sibley
- Phone Number: 617.552.1758
- Email: erin.sibley@bc.edu
Study Locations
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Massachusetts
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Chestnut Hill, Massachusetts, United States, 02467
- Boston College
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Contact:
- Elizabeth Kensinger
- Phone Number: 617-552-1350
- Email: elizabeth.kensinger@bc.edu
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-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- All participants: willing and able to follow the protocol
- All participants: fluent in English
- Online participants: online account in the crowdsourcing platform that will be used (e.g., Prolific)
Exclusion Criteria:
- All participants: history of a psychiatric or neurological condition, and/or current psychotropic drug use (indicated by the participant)
- 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 |
Intervention / Treatment |
---|---|
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)
|
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
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).
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Day 3
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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.
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Day 2
|
Secondary Outcome Measures
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).
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Day 3
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Change in Resting-State Functional Connectivity
Time Frame: Day 2
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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).
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Day 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 1, 2024
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Study Registration Dates
First Submitted
July 26, 2023
First Submitted That Met QC Criteria
July 26, 2023
First Posted (Actual)
August 3, 2023
Study Record Updates
Last Update Posted (Actual)
August 3, 2023
Last Update Submitted That Met QC Criteria
July 26, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID 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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