Episodic MemoryNCT05974371
Episodic Memory Integration and Interference
A study testing emotional context similarity in people with Episodic Memory, run by Boston College at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Episodic Memory
- What is being tested?
- emotional context similarity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston College
Chestnut Hill, Massachusetts, 02467
Elizabeth Kensinger, 617-552-1350, elizabeth.kensinger@bc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Episodic Memory
- Being tested
- emotional context similarity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotional context similarityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Emotional memory updating paradigm | Experimental | All participants will encode AB/AC word pairs shown with images that have differing emotional valence (positive, negative, or neutral) Receives: Other: emotional context similarity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory for the Associated Words
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).
Measured: Day 3
fMRI Measured Neural Reactivity (Blood Oxygen-Level Dependent Signal)
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.
Measured: Day 2
Secondary outcomes (2)
Source Memory
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).
Measured: Day 3
Change in Resting-State Functional Connectivity
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).
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study startAug 2024 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic MemoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974371
- Sponsor's protocol ID
- MH134570
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Basic Science Study on Episodic Memory Integration and Interference in Healthy Adults
- ClinicalTrials.gov ID
- NCT05974371
- Acronym / sponsor ID
- MH134570
- Conditions
- Episodic Memory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emotional memory updating paradigm | Experimental | Other: emotional context similarityAll participants will encode AB/AC word pairs shown with images that have differing emotional valence (positive, negative, or neutral) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emotional context similarityOn 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. | Other | Emotional memory updating paradigm |
Primary outcome
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).
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.
2 secondary outcomes
Source Memory
Time frame: Day 3
Change in Resting-State Functional Connectivity
Time frame: Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotional context similarity in people with Episodic Memory, run by Boston College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Sibley (617.552.1758, erin.sibley@bc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory for the Associated Words (time frame: Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.