Draft of experiment protocol

[AlyciaWinters]

@georgebuzzell

Purpose

Broadly, this study aims to examine the relationship between cognitive functioning, individual personality or social factors, and mental health outcomes; specifically social anxiety and behavioral inhibition.

Background

Broadly, this study aims to clarify relations between particular cognitive abilities, personality and social factors, and mental health outcomes such as social anxiety. Prior work suggests that individuals with a temperament known as “behavioral inhibition” are more likely to develop social anxiety if they also exhibit particular profiles of cognitive control ability, including impaired task switching or superior inhibitory control (White et al., 2011; Buzzell et al., 2020). However, it remains unclear how much these associations depend on the context in which task switching and inhibitory control are assessed (i.e. within social settings as opposed to while alone). Additionally, it remains unclear if these associations depend on the temperament of the individual, other personality or social factors, or are present for the majority of individuals with social anxiety. There is at least some work to suggest that the link between some forms of cognitive control (e.g. error monitoring) and social anxiety are influenced by whether cognitive control is assessed within a social context or not (Buzzell et al., 2017). However, there is little work investigating the effect of social context on relations between social anxiety, task switching, and inhibitory control. The current study aims to not only close these gaps in the literature, but also provide a more broad investigation of how cognitive functioning, and personality or social factors, relate to mental health outcomes. Towards these ends, participants will perform a task battery that is designed to assess task switching, and inhibitory control, when responding to either social stimuli (faces) or neutral stimuli (scrambled faces) while EEG data is recorded. Additionally, the task battery will be performed twice, once while alone and once while being observed by the experimenter. Task development was based on the modification of existing paradigms and using a standardized set of face stimuli (Lundqvist et. al., 1998).

Goals

1. To determine whether there is an association between social anxiety and specific executive functions (task switching and inhibitory control)
2. To determine whether relations between social anxiety and cognitive control depend on social context or an individual’s temperament
3. To explore more generally how individual differences in cognitive functioning, personality, or social factors relate to mental health outcomes more generally.

Recruitment

• Participants will be recruited from students at Florida International University through SONA and through advertisement such as flyers. In the SONA advertisement and flyers, information about the study procedures, duration, voluntary nature of the study, eligibility criteria, and credit hours or monetary compensation amount will be provided. Interested individuals that sign up via SONA will be invited to complete a short screening questionnaire on RedCap to confirm eligibility.

- Eligibility criteria:

• Must be between ages 18-24.
• Must be fluent in English.
• Must be right handed.
• Must have normal or corrected-to-normal vision (i.e., can see color normally, and if you need glasses, you are wearing them or contact lenses).
• Must not have ever had a head trauma that resulted in a loss of consciousness for more than five minutes.
• If participants do not meet the eligibility criteria, they will be informed that they are ineligible and their timeslot will be dropped.
• If participants are eligible, they will continue with the study.***need to elaborate (partially depends on scheduling procedures)

Scheduling

• Rough idea right now: Schedule rooms based on time slots (vs. as people sign up for them) and have main experimenter schedule the room.

Data Collection and Reporting

• Data collected include behavioral task measures (e.g., response time and accuracy rate), EEG data during the behavioral task, and self-report measures. Study data will be collected via secure RedCap servers and password protected laptops (EEG and behavioral data). Data collected through RedCap and on the experiment laptop will be transferred to FIU’s secure servers by authorized personnel while connected to the FIU VPN.

• Only anonymized data will be shared publicly, for example via the Open Science Framework (https://osf.io/) or the OpenNeuro project (https://openneuro.org/). Any identifying information will be stripped from the data (such as any names, phone numbers, location information, etc.) prior to sharing. All results will be presented in aggregate in publications/presentations.

• Data from the study will be deleted after the date the study is completed.

Participant Withdrawal

• All participants are free to withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. Participants will be reminded regularly that the study is completely voluntary and that if they do not wish to participate, they may withdraw at any time. They will also be regularly reminded that they can request that their contact information be permanently deleted at any time.

Methods

• Once participants arrive, they will be greeted by the experimenters who will lead them back to the experiment room where they will have the procedures of EEG set-up and the overall study explained to them, and they will complete the consent form for the study. Participants will additionally be informed that they may be contacted in the future for follow-up assessments with similar measures. Additional assessments will include additional consent processes and require IRB approval, and the participant can decline to be re-contacted.

• If the participant consents to participate in the study, they will have their head measured to figure out the correct cap size and be asked to complete a battery of questionnaires (see below) that assess overall psychosocial functioning and various personality traits while the experimenters connect the electrodes to the cap to ensure that their answers are private and confidential.

• After completing the questionnaires, the experimenters will begin setting up the EEG equipment which includes fitting a cap and filling the ports with a water-based gel needed to obtain EEG data. Throughout the setup process, participants will be informed of what the next steps of set up are.

• After EEG setup is complete, the main experimenter will instruct the participants on the next part of the experiment where they will be completing a behavioral task (see below) and have them complete practice version of the task. The experimenter will remain in the room while the participant completes the practice version so that they can ask any questions they may have and the experimenter can confirm the participant understands the tasks. Once the practices are completed, the experimenter will inform participants that they will be completing the same behavioral task either while the experimenter is observing or once the experimenter leaves the room. The order of these conditions will be counterbalanced.

• Social observation condition: Participants will be told that they will be completing the behavioral task while the experimenter observes them. There will be regular breaks between each block of trials. Following the completion of the tasks, participants will complete the SSSQ via RedCap.

• Alone condition: Participants will be told that they will be completing the behavioral task alone and that they can begin the task as soon as the experimenter leaves the room and the experimenter will return once they have completed the behavioral task. There will be regular breaks between each block of trials. Following the completion of the task, participants will complete the SSSQ via RedCap.

Questionnaires (completed via RedCap)

• Demographics Questionnaire: assesses individual demographic differences.
• Covid Experiences Questionnaire: assesses daily social and health experiences before/during the pandemic.
• Everyday Discrimination Scale (Short Version) and Heightened Vigilance Scale: assesses experiences of discrimination in everyday life and the heightened vigilance associated with such experiences.
• Adult Measure of Behavioral Inhibition (AMBI): assesses trait inhibition, with respect to response to social novelty and risk stimuli.
• Retrospective Measure of Behavioral Inhibition (RMBI): retrospectively assesses inhibitory behaviors present during primary school years.
• Screen for Adult Anxiety Related Disorders (SCAARED): assesses for multiple anxiety disorders, such as general anxiety disorder, separation anxiety disorder, panic disorder, and social phobia.
• The Affective Reactivity Index (ARI): assesses trait irritability
• Interpersonal Emotion Regulation Questionnaire (IERQ): assesses interpersonal emotion regulation
• Repetitive Thinking Questionnaire (RTQ): assesses repetitive negative thinking as it relates to multiple disorders and emotions. Assessment of the RTQ involves first assessing 10 items from the Positive and Negative Affect Scale (PANAS) - Negative Affect subscale
• Social Reward Questionnaire (SRQ): assesses individual differences in the valuing of social reward
• Intolerance of Uncertainty Scale (IUS-12): assesses responses to uncertainty, the future, and ambiguous situations
• Emotion Regulation Questionnaire (ERQ): assesses individual differences in cognitive reappraisal and expressive suppression
• Social Interaction Anxiety Scale (SIAS-6) and Social Phobia Scale (SPS-6): assesses severity of social phobia and social anxiety disorders
• Highly Sensitive Person Scale (HSPS): assesses the degree of sensitivity within adult individuals
• Initial State Questionnaire: assesses how the participant is feeling at the current moment on a variety of dimensions (how tired, how excited, etc.) as well as how much sleep they had the prior night and their caffeine intake for the day
• Brief Fear of Negative Evaluation-II: assess how the participant thinks and feels about other people observing and evaluating them.
• Short Stress State Questionnaire (SSSQ): assesses how the participant is feeling at the current moment on a variety of dimensions (engagement, distress, worry). The participant will complete a pre-task version of this questionnaire and then complete a post-task version of this questionnaire after completing the behavioral tasks
• Adult Executive Functioning Inventory- Self Report Version (ADEXI): assesses self-reported executive function skills
• BAARS IV Self-Report Version (BAARS-IV): assesses self-reported ADHD symptoms
• Patient Health Questionnaire - 8-item version (PHQ-8): assesses self-reported depression symptoms but omits a 9th question (of the original PHQ-9) related to self-harm
• Short Autism Spectrum Quotient (AQ-10): assesses symptoms associated with autism spectrum disorder using a shortened,10-item questionnaire
• Trauma History Questionnaire (THQ): assesses the timing and types of traumatic events that the participant may have previously experienced in their life

Task (using Psychopy)

• Color/Shape Face Flanker Task: involves presentation of an array of visual target and distractor stimuli each trial in which the participant must ignore distractors and respond according to the target displayed. Stimulus arrays consist of scrambled and unscrambled faces superimposed upon various shapes (e.g. circles, squares) that vary in color (e.g. orange, blue). Faces are drawn from the Chicago Face database (https://chicagofaces.org) and are further modified using Photoshop, the MATLAB SHINE Toolbox, and other software. Across trials or blocks, participants are required to change the relevant stimulus dimension (e.g. color, shape, facial feature) that must be attended to in order to make a correct response. Additionally, the same stimuli are used for an additional block in which the instructions are changed, such that participants must remember what stimuli were previously presented and report on whether the current stimulus is the “same” or “different” then stimuli presented one or two trials prior.

Study Schedule

Eligible individuals will complete the following:

• Obtain informed consent (~10 minutes). Participants will complete the consent form after arriving to the study location.
• Complete questionnaires (~50 minutes). After consenting to participate, participants will complete a battery of questionnaires via RedCap.
• EEG Setup (~35 minutes). After completing the questionnaires, the experimenters will fit the participants with an EEG cap and set up the equipment for recording EEG data.
• Complete practice behavioral task (~10 minutes). After EEG setup is complete, participants will then complete short practice version of the task with the main experimenter present.
• *Complete behavioral task (1 hour 20 minutes).**
• Completing task alone (~40 minutes). The participant will complete the tasks alone. For more information on this condition, see the “Method” section.
• Completing task under supervision (~40 minutes). The participant will complete the tasks while the main experimenter is in the room. For more information on this condition, see the “Method” section.
• Complete questionnaire (~5 minutes). Once tasks are complete, the participant will complete a questionnaire that assessing how they are currently feeling.
• EEG Takedown and Debriefing (~15 minutes). Experimenters will take the equipment off of the participant. Participants will be debriefed afterwards and will be informed that they may be recontacted in the future to participate in follow-up studies, and they are free to decline any future invitations or request that their contact information be deleted at any time.

Data analysis plan

• Data will be analyzed using regression models through statistical software packages including, but not limited to R, JASP, and Python.

Data Management

Personal information will be collected and stored on secure servers in a password-protected, encrypted format that is only accessible by authorized study personnel. Identifiable information will only be handled and accessed by trained RAs, the PI and any co-investigators that are approved through future amendments. All must have completed CITI training. There are no physical copies of study materials. Participants will be informed that they can request to have their personal information removed from the database at any time (leaving only their unique ID and study data, with no possible way of re-identifying them in the future). Study data will be collected via secure RedCap servers and on secure password protected laptops (EEG and behavioral data). Data collected through RedCap and on the laptops will be transferred to FIU’s secure servers by authorized personnel while connected to the FIU VPN. To ensure the confidentiality of the data, participants will be identified with a participant identification number and all results will be presented in aggregate in publications/presentations. Only de-identified data will be shared publicly, for example via the Open Science Framework or the OpenNeuro project. Any copies of identifiable data (such as on backup hard drives) will be password-protected and encrypted (AES-256) and housed in a secured area of a building where only individuals with key or key card access may enter. All questionnaires will be stored and protected in RedCap. RedCap was specifically designed to provide investigators with an online data collection platform with high participant information security. To achieve this, RedCap has features that include: 1) host-based firewalls that protect the application server, the database server, and the actual file system for storing data, 2) SSL encryption, 3) removal of identifiers during data export, 4) audit trails for tracking data changes, 5) daily backups to protect against data loss or corruption of data, and 6) settings for controlling data access. After the study is concluded, participant EEG and behavioral data will be permanently deleted from the laptop.

Data Naming Conventions

• ***need to figure this out

Data Monitoring

• The Principal Investigator and co-investigators will be responsible to ensure the study is conducted in accordance with the protocol and that the data recorded is valid. To achieve this objective, the study will be continuously monitored and reviewed on a monthly basis by the study team.

• The data obtained from the task (EEG and behavioral) will be transferred from the experiment laptop to the administrator’s computers, which will later be transferred to FIU's secure servers. The data transferred to an authorized administrator will be done while the administrator is still connected to the FIU VPN.

• Following the completion of the protocol by a participant, investigators have 72 hours to ensure that all data has been successfully recorded and transferred to FIU’s secure servers. In order to prevent data loss, multiple study personnel will check that the data has been successfully transferred post completion. Once data transfer to FIU’s secure servers have been confirmed, the administrator will be asked to delete the data from their computer. The task data will be deleted from the experiment laptop following completion of the study.

Institutional Review Board

• The protocol, consent form(s), and all participant materials will be submitted to the IRB for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. All changes to the consent form will be IRB approved; a determination will be made regarding whether previously consented participants need to be re-consented.

Consent Process

• At the beginning of the study, consent will be received from participants. In order to continue the study, participants must complete the consent form. The informed consent, approved by the IRB, provides a detailed explanation of the study protocol, potential risks and discomforts, the confidentiality of their data, and the use of their information will be provided. During this explanation, they will be reminded that the records of this study will be kept private and protected to their fullest extent, and that all potential identifiers associated with them will be removed from their data. Contact information for the study PI will be provided on the consent form, and participants are encouraged to call/text/email the study PI with any questions or concerns they may have prior to providing consent. Once the informed consent is signed, the subject will be emailed a copy of the document.

Publication and Data Sharing Policy

• The preparation and submission for publication of manuscripts containing the study results shall be in accordance with a process determined by mutual written agreement among the study sponsor and participating institutions.

[AlyciaWinters]

Based on conversation on slack -->

• need to add in parts mentioning paying participants/recruiting with flyers as well
• Schedule rooms based on time slots (vs. when people sign up for them)

[AlyciaWinters]

• Drop sleep quality index
• Drop Social Interaction and Comm Skills Checklist
• May drop more

[AlyciaWinters]

• Edit where it says initial state questionnaire after tasks in methods section
• Look at social context data to decide SSSQ or thoughts/feelings questionnaire

[AlyciaWinters]

• Probably split inhibition task and switching tasks in psychopy

[AlyciaWinters]

• Drop sleep quality index
• Drop Social Interaction and Comm Skills Checklist
• May drop more

Dropped the two listed here

[AlyciaWinters]

Based on conversation on slack -->

• need to add in parts mentioning paying participants/recruiting with flyers as well
• Schedule rooms based on time slots (vs. when people sign up for them)

Added in verbiage about flyers and monetary compensation. Added rough wording for scheduling.

[AlyciaWinters]

• Edit where it says initial state questionnaire after tasks in methods section
• Look at social context data to decide SSSQ or thoughts/feelings questionnaire

Edited section in methods. Have not looked at SC data yet

[AlyciaWinters]

Additional questions that came up while working on things:

• Is the main experimenter going to be reading the instructions and going through the practice with participants? Or are we having the participants do this on their own and trusting they actually read and understand it similar to how the online study is run? In Jason's lab we would always do this to ensure they understood the task, answer any questions and made sure they were comfortable and emphasized that they needed to be as still as possible, and also it gave the second experimenter time to ensure the data was coming in okay and task was saving (e.g., sometimes RAs would forget this and it would be caught by the lab managers since we were always near by and checking in or the main experimenter before they went to read the instructions/do the practice with participants)

• By splitting tasks, do you mean have two separate psychopy experiments, or just splitting into two separate blocks? I guess I didn't think to ask this last week.