Anxiety Depression DisorderNCT06406595
Hemispheric Asymmetries in Emotion-Cognition Interactions
An observational study of Anxiety Depression Disorder, run by University of Alberta at 1 site in Canada.
Trial summary
In this research, the investigators will recruit 2 groups of individuals: older adults (aged over 65) with anxiety and/or depression and older adults without mental health issues. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression Disorder
- What is being tested?
- Observation
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Healthy older adult aged over 60 who do not exhibit mental health issues and demonstrate healthy aging from a cognitive perspective. 2. Older adults aged over 60 who have been diagnosed with Anxiety and/or Depression, while still demonstrating healthy aging from a cognitive standpoint. Participants with Edinburgh Handedness Inventory scores falling within the range of [-100, -41] and [41, 100] are eligible to participate in this study.
Who may be able to join
- The healthy older adult group is composed of participants aged over 60 who do not exhibit mental health issues and demonstrate healthy aging from a cognitive perspective.
- The older adults with mental health issues group will consist participants aged over 60 diagnosed with these conditions are included while still demonstrating healthy aging from a cognitive standpoint.
Who cannot join
- Participants currently taking medication known to affect brain activity and/or cognitive processing.
- Participants with a history of alcohol or substance abuse.
- Participants with a history of head injury or concussion that may impact brain activity and/or cognitive processing.
- Participants with Neurological Disorders.
- Participants with Edinburgh Handedness Inventory scores falling within the range of [-40, 40].
Trial locations and contacts
1 site in 1 country.
About this study
In this research, the investigators will recruit 2 groups of individuals: older adults (aged over 65) with anxiety and/or depression and older adults without mental health issues. Individuals who are eligible to participate in the study based on their score in the Edinburgh Handedness Inventory (EHI) showing their hand preferences will have the opportunity to sign up using the online form created by the research team. This experiment will take place in an electroencephalogram (EEG) lab. Participants will wear an EEG cap with 256 sensors that record their brain activity while completing an emotional oddball task containing emotional pictures and shapes. The task will take approximately 1 hour with 8 short breaks. EEG is a safe and non-invasive testing technique, and participants will feel little or no discomfort during this EEG experiment. The goal of this study is to investigate the effect of fearful emotion on the cognitive oddball task to deepen understanding of the emotion-cognition interaction in older adults with mental health conditions.
Read the detailed description
The purpose of this study is to investigate the effect of fearful emotion on the cognitive oddball task using electroencephalogram (EEG) technology. The study aims to deepen the understanding of the emotion-cognition interaction in humans. Emotions are fundamental to human behavior, and they can have a significant impact on cognitive processes such as attention, memory, and decision-making. Furthermore, the relationship between emotion and cognition has been implicated in numerous psychiatric disorders, including anxiety, depression, and post-traumatic stress disorder. Therefore, understanding the mechanisms by which emotions affect cognition is essential for the development of effective treatments for these disorders.
Electroencephalography (EEG) is a non-invasive and widely-used technique that measures the electrical activity of the brain, making it an excellent tool for studying the relationship between emotion and cognition. This study will use EEG to examine the neural correlates of attentional processing in response to emotional stimuli. Specifically, the investigators will use an emotional oddball task to investigate the effect of fearful emotions on the attention of deviant stimuli, which is an established paradigm in the study of emotion and cognition.
Furthermore, this study will explore the impact of the location of the deviant stimuli presentation (i.e., in the left or right visual field) on the emotion-cognition interaction. This variable is crucial because previous research has suggested hemispheric asymmetries in emotion processing and contralateral visual processing. By including this variable in the study, the investigators will be able to examine whether the emotion-cognition interaction is influenced by the location of stimulus presentation.
Additionally, the investigators will include 2 groups: older adults with anxiety and/or depression, and older adults without mental health issues. By examining these different groups, the investigators aim to elucidate how mental health status may modulate emotion-cognition interactions.
The inclusion of novel variables, such as the location of stimulus presentation and mental health status, makes this study innovative and likely to produce novel findings that will contribute to the existing literature on this topic. It is hypothesized that the presentation of fearful images in the cognitive oddball task will result in greater changes in brain electrical activity as compared to neutral images. Specifically, the investigators expect to observe increased activity in the ventral affective system (e.g., amygdala) and other regions of the brain associated with emotional processing. The investigators also hypothesize that the location of the shape presentation (whether on the left or right visual field) may modulate the effect of emotion on cognition by influencing the event-related potentials (ERPs) in dorsal executive system (e.g., dorsal lateral prefrontal cortex (dlPFC)).
The objectives of this study are:
- To investigate the effect of fearful emotion on the cognitive oddball task using EEG technology.
- To analyze changes in brain electrical activity in response to fearful and neutral stimuli.
- To investigate whether the location of shape presentation (left or right visual field) modulates the effect of emotion on cognition.
- To explore how mental health status may modulate emotion-cognition interactions.
Research Method/Procedures:
Participants who meet the inclusion criteria (strong handedness) will be scheduled for a one-hour session in the EEG lab. During the session, participants will wear an EEG cap with 256 channels that record their brain electrical activity while they complete an emotional oddball task. The task will consist of fearful and neutral pictures and black circles that are shown in the middle, left, or right visual field of the screen. The frequency of shapes appearing in the left or right visual field will be varied to investigate the impact of visual field location. The task duration will be approximately 1 hour with 8 short breaks during the processing.
For data analysis, the investigators will analyze the EEG data using time-frequency analysis to identify changes in brain electrical activity in response to fearful and neutral stimuli. The investigators will compare the results of the odd stimulus after fearful images with that after neutral images to isolate the effect of emotions on cognitive processing. The investigators will also use statistical analysis to identify any significant differences in the impact of visual field location on the effect of emotion on cognition. Finally, the investigators will interpret our findings in the context of existing literature on the emotion-cognition interaction in humans, and conduct cross-sectional comparisons between different mental health conditions to investigate the generalizability of the findings.
- Conditions
- Anxiety Depression Disorder
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
This study is observational, therefore, there is no intervention included.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults Healthy Control Group | The healthy older adult group is carefully defined to serve as a comparison group against individuals with mental health issues. By selecting participants aged over 60 who do not exhibit mental health issues and demonstrate healthy aging from a cognitive perspective, the investigators establish a baseline for cognitive functioning within the older adult population. Receives: Other: Observation | |
| Older Adults with Mental Health Issues Group | The older adults with mental health issues group is crucial for examining the impact of Anxiety and/or Depression on cognitive aging. Participants aged over 60 diagnosed with these conditions are included while still demonstrating healthy aging from a cognitive standpoint. This ensures that any observed cognitive differences can be attributed to mental health conditions rather than age-related decline alone. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-related potentials(ERPs): Peak Amplitude of P100, P300, and Late Positive Potential
This study investigates Event-Related Potentials (ERPs), focusing on P100, P300, and Late Positive Potential (LPP). The peak amplitude of these components reflects the maximum voltage deflection recorded from the scalp during these time windows following specific stimuli. By analyzing the peak amplitude, the investigators aim to explore the neural mechanisms implicated in cognitive functions such as attention, decision-making, and emotional processing.
Measured: After the raw EEG data being collected, the investigators plan to conduct preprocessing, independent component analysis and extract ERPs of our interest starting in January 2025.
Event-related potentials(ERPs): Latency of P100, P300, and Late Positive Potential
This study investigates Event-Related Potentials (ERPs), focusing on P100, P300, and Late Positive Potential (LPP). The latency of these components represents the time between the presentation of a stimulus and the peak activity they exhibit. The value of latency lies in its precision regarding the timing of cognitive processes. Through latency analysis, the investigators gain a detailed understanding of the sequential progression of neural events.
Measured: After the raw EEG data being collected, the investigators plan to conduct preprocessing, independent component analysis and extract ERPs of our interest starting in January 2025.
Magnitude of Rhythmic Activity in EEG Oscillations: Alpha, Theta, and Delta Bands
This study explores emotion and visual attention aspects within EEG oscillations, particularly in the Alpha, Theta, and Delta bands. These bands are known to influence emotional processing and attentional mechanisms.
Measured: After the raw EEG data being collected, the investigators plan to conduct preprocessing, independent component analysis and extract EEG bands of our interest starting in January 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Sep 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Depression DisorderStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Singhal, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406595
- Sponsor's protocol ID
- Pro00130303
- Status last verified
- Jul 2025
- First submitted
- 6 May 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemispheric Asymmetries in Emotion-Cognition Interactions
- ClinicalTrials.gov ID
- NCT06406595
- Acronym / sponsor ID
- Pro00130303
- Conditions
- Anxiety Depression Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 9 May 2024 (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.
In this research, the investigators will recruit 2 groups of individuals: older adults (aged over 65) with anxiety and/or depression and older adults without mental health issues. Individuals who are eligible to participate in the study based on their score in the Edinburgh Handedness Inventory (EHI) showing their hand preferences will have the opportunity to sign up using the online form created by the research team. This experiment will take place in an electroencephalogram (EEG) lab. Participants will wear an EEG cap with 256 sensors that record their brain activity while completing an emotional oddball task containing emotional pictures and shapes. The task will take approximately 1 hour with 8 short breaks. EEG is a safe and non-invasive testing technique, and participants will feel little or no discomfort during this EEG experiment. The goal of this study is to investigate the effect of fearful emotion on the cognitive oddball task to deepen understanding of the emotion-cognition interaction in older adults with mental health conditions.
Detailed description
The purpose of this study is to investigate the effect of fearful emotion on the cognitive oddball task using electroencephalogram (EEG) technology. The study aims to deepen the understanding of the emotion-cognition interaction in humans. Emotions are fundamental to human behavior, and they can have a significant impact on cognitive processes such as attention, memory, and decision-making. Furthermore, the relationship between emotion and cognition has been implicated in numerous psychiatric disorders, including anxiety, depression, and post-traumatic stress disorder. Therefore, understanding the mechanisms by which emotions affect cognition is essential for the development of effective treatments for these disorders.
Electroencephalography (EEG) is a non-invasive and widely-used technique that measures the electrical activity of the brain, making it an excellent tool for studying the relationship between emotion and cognition. This study will use EEG to examine the neural correlates of attentional processing in response to emotional stimuli. Specifically, the investigators will use an emotional oddball task to investigate the effect of fearful emotions on the attention of deviant stimuli, which is an established paradigm in the study of emotion and cognition.
Furthermore, this study will explore the impact of the location of the deviant stimuli presentation (i.e., in the left or right visual field) on the emotion-cognition interaction. This variable is crucial because previous research has suggested hemispheric asymmetries in emotion processing and contralateral visual processing. By including this variable in the study, the investigators will be able to examine whether the emotion-cognition interaction is influenced by the location of stimulus presentation.
Additionally, the investigators will include 2 groups: older adults with anxiety and/or depression, and older adults without mental health issues. By examining these different groups, the investigators aim to elucidate how mental health status may modulate emotion-cognition interactions.
The inclusion of novel variables, such as the location of stimulus presentation and mental health status, makes this study innovative and likely to produce novel findings that will contribute to the existing literature on this topic. It is hypothesized that the presentation of fearful images in the cognitive oddball task will result in greater changes in brain electrical activity as compared to neutral images. Specifically, the investigators expect to observe increased activity in the ventral affective system (e.g., amygdala) and other regions of the brain associated with emotional processing. The investigators also hypothesize that the location of the shape presentation (whether on the left or right visual field) may modulate the effect of emotion on cognition by influencing the event-related potentials (ERPs) in dorsal executive system (e.g., dorsal lateral prefrontal cortex (dlPFC)).
The objectives of this study are:
- To investigate the effect of fearful emotion on the cognitive oddball task using EEG technology.
- To analyze changes in brain electrical activity in response to fearful and neutral stimuli.
- To investigate whether the location of shape presentation (left or right visual field) modulates the effect of emotion on cognition.
- To explore how mental health status may modulate emotion-cognition interactions.
Research Method/Procedures:
Participants who meet the inclusion criteria (strong handedness) will be scheduled for a one-hour session in the EEG lab. During the session, participants will wear an EEG cap with 256 channels that record their brain electrical activity while they complete an emotional oddball task. The task will consist of fearful and neutral pictures and black circles that are shown in the middle, left, or right visual field of the screen. The frequency of shapes appearing in the left or right visual field will be varied to investigate the impact of visual field location. The task duration will be approximately 1 hour with 8 short breaks during the processing.
For data analysis, the investigators will analyze the EEG data using time-frequency analysis to identify changes in brain electrical activity in response to fearful and neutral stimuli. The investigators will compare the results of the odd stimulus after fearful images with that after neutral images to isolate the effect of emotions on cognitive processing. The investigators will also use statistical analysis to identify any significant differences in the impact of visual field location on the effect of emotion on cognition. Finally, the investigators will interpret our findings in the context of existing literature on the emotion-cognition interaction in humans, and conduct cross-sectional comparisons between different mental health conditions to investigate the generalizability of the findings.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older Adults Healthy Control Group | – | Other: ObservationThe healthy older adult group is carefully defined to serve as a comparison group against individuals with mental health issues. By selecting participants aged over 60 who do not exhibit mental health issues and demonstrate healthy aging from a cognitive perspective, the investigators establish a baseline for cognitive functioning within the older adult population. |
| Older Adults with Mental Health Issues Group | – | Other: ObservationThe older adults with mental health issues group is crucial for examining the impact of Anxiety and/or Depression on cognitive aging. Participants aged over 60 diagnosed with these conditions are included while still demonstrating healthy aging from a cognitive standpoint. This ensures that any observed cognitive differences can be attributed to mental health conditions rather than age-related decline alone. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Healthy older adult aged over 60 who do not exhibit mental health issues and demonstrate healthy aging from a cognitive perspective. 2. Older adults aged over 60 who have been diagnosed with Anxiety and/or Depression, while still demonstrating healthy aging from a cognitive standpoint. Participants with Edinburgh Handedness Inventory scores falling within the range of [-100, -41] and [41, 100] are eligible to participate in this study.
Key inclusion criteria (2 listed)
- The healthy older adult group is composed of participants aged over 60 who do not exhibit mental health issues and demonstrate healthy aging from a cognitive perspective.
- The older adults with mental health issues group will consist participants aged over 60 diagnosed with these conditions are included while still demonstrating healthy aging from a cognitive standpoint.
Key exclusion criteria (5 listed)
- Participants currently taking medication known to affect brain activity and/or cognitive processing.
- Participants with a history of alcohol or substance abuse.
- Participants with a history of head injury or concussion that may impact brain activity and/or cognitive processing.
- Participants with Neurological Disorders.
- Participants with Edinburgh Handedness Inventory scores falling within the range of [-40, 40].
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 |
|---|---|---|
| ObservationThis study is observational, therefore, there is no intervention included. | Other | Older Adults Healthy Control Group, Older Adults with Mental Health Issues Group |
Primary outcome
Event-related potentials(ERPs): Peak Amplitude of P100, P300, and Late Positive Potential
Time frame: After the raw EEG data being collected, the investigators plan to conduct preprocessing, independent component analysis and extract ERPs of our interest starting in January 2025.
This study investigates Event-Related Potentials (ERPs), focusing on P100, P300, and Late Positive Potential (LPP). The peak amplitude of these components reflects the maximum voltage deflection recorded from the scalp during these time windows following specific stimuli. By analyzing the peak amplitude, the investigators aim to explore the neural mechanisms implicated in cognitive functions such as attention, decision-making, and emotional processing.
Event-related potentials(ERPs): Latency of P100, P300, and Late Positive Potential
Time frame: After the raw EEG data being collected, the investigators plan to conduct preprocessing, independent component analysis and extract ERPs of our interest starting in January 2025.
This study investigates Event-Related Potentials (ERPs), focusing on P100, P300, and Late Positive Potential (LPP). The latency of these components represents the time between the presentation of a stimulus and the peak activity they exhibit. The value of latency lies in its precision regarding the timing of cognitive processes. Through latency analysis, the investigators gain a detailed understanding of the sequential progression of neural events.
Magnitude of Rhythmic Activity in EEG Oscillations: Alpha, Theta, and Delta Bands
Time frame: After the raw EEG data being collected, the investigators plan to conduct preprocessing, independent component analysis and extract EEG bands of our interest starting in January 2025.
This study explores emotion and visual attention aspects within EEG oscillations, particularly in the Alpha, Theta, and Delta bands. These bands are known to influence emotional processing and attentional mechanisms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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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. This study is not recruiting at the moment.
Anthony Singhal, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Depression Disorder, run by University of Alberta at 1 site in Canada.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jul 2025. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-related potentials(ERPs): Peak Amplitude of P100, P300, and Late Positive Potential (time frame: After the raw EEG data being collected, the investigators plan to conduct preprocessing, independent component analysis and extract ERPs of our interest starting in January 2025.). The study lists 3 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 9 Jul 2025.