D2D Normative Data for Remote Assessments

Cognition Clinical Trial

Official title:

Collection of Normative Data for iPad-Based Cognitive Assessment Tools

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03206775
• Other study ID #: STUDY00000319
• Status: Completed
• Start date: June 6, 2017
• Est. completion date: March 25, 2019

Study information

• Verified date: February 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Phase 1: This is a remote observational study in which participants will complete cognitive assessments developed by Posit Science. Participants will be healthy controls aged 18-65 with reliable internet access and a device that they can use to access the assessments, such as a laptop or iPad. Participants will complete up to 6 Posit Science assessments in different domains of cognition, which should last approximately 30 minutes.

Phase 2: This is an in person observational study in which participants will complete cognitive assessments developed by Posit Science. Participants will be healthy controls aged 18-80 who are fluent in English. Participants will complete batteries of cognitive assessments developed by Posit Science, which include combinations of visual, auditory, and social cognitive assessments, and self-report questionnaires. This study will be conducted at the Driven to Discover building at the Minnesota State Fair. Participation will last approximately 20 minutes.

Phase 3: Participants in Phase 3 will complete a Posit Science assessment battery and self-report questionnaires. Each participant will be asked to provide brief demographic and medical history data. Participants will be aged 18-35 and will be students at the University of Minnesota who are enrolled in the Research Experience Points program. Participants will complete the assessment battery remotely; the battery will take approximately 45-60 minutes to complete.

Phase 4: This is a pilot program to test the use of remote cognitive assessment and training in adolescents with an anxiety diagnosis and healthy controls. Participants will complete a short assessment battery, then will receive 4 hours of cognitive training over 2 weeks at home. Then they will repeat the battery. Total participation should last approximately 5 hours over 2-3 weeks and will be completed entirely remotely.

Description:

Phase 1: Remote Assessment with Old Battery (Enrollment period: June-August 2017. CLOSED TO ENROLLMENT) Participants who have successfully completed the online consent process may begin study procedures. A member of the research staff will connect the participant to the Posit Science battery remotely using their laptop or iPad through the BrainHQ portal. All Posit Science assessments have a brief training section before the assessment begins. Participants will be instructed to be in a quiet place free of distractions where they can turn up the volume on their device or use headphones to complete the auditory portions of the assessment. The battery will consist of 6 exercises and will last approximately 20 minutes, which will be completed in a single sitting. Data to be captured will include response time, accuracy, and time to complete the assessment. These data will be stored confidentially within the Posit Science servers and will later be downloaded onto an external device for data analysis and interpretation. Once participants have completed the batter, a member of the study staff will send their compensation.

Phase 2: Minnesota State Fair (Enrollment period: 2017-2022) Participants who have successfully completed the consent process may begin study procedures. A member of the research staff will connect the participant to the REDCap self-report surveys on an iPad. The surveys will be contained within a directory listed under the participant's unique study identifier and will not contain any personally identifying information. The first survey will collect demographic information such as age, gender, ethnicity/race, zip code of residence, education level, current medications, and personal and familial psychiatric and neurological history. This information will be collected in a self-report survey form to avoid embarrassment or stigma that could result if the participant was overheard answering these questions. After completing the demographic survey and brief medical history, all participants will complete self report questionnaires. The self-report assessments should take approximately 2 minutes to complete.

After the completion of the self-report items, the participant will be automatically redirected to the cognitive battery to which they have been randomized. They will be asked to log in to the BrainHQ portal using the same email address they provided before. They will be prompted for their name; study staff will instruct participants to enter "State" for their first name and "Fair" for their last name. However, study staff will not directly oversee participants while they create their account, and so some may not follow these instructions and may disclose their full name to Posit Science. All Posit Science assessments have a brief training section before the assessment begins. If the participant is still having trouble understanding the assessment, study staff will be available to help explain the tasks. Participants will be provided with over-the-ear headphones with disposable sanitary pads for auditory components. Each battery will consist of 4-6 Posit Science assessments, which last approximately 2-3 minutes each. The cognitive battery should last approximately 12-15 minutes. Data to be captured will include response time, accuracy, and time to complete the assessment. These data will be stored confidentially within the Posit Science servers and will later be downloaded onto an AHC managed device for analysis and interpretation. When downloaded to the AHC server, they will be de-identified and collated using a unique participant ID.

At the end of the cognitive assessment battery, participants will be asked to complete a short feasibility survey on REDCap which will ask them their opinion of the tasks they completed and how likely they would be to use these kinds of programs. This survey should take approximately 1-2 minutes. Then participants will receive their compensation and their participation will be complete.

Phase 3: Research Experience Program (REP) Project (Enrollment period: Spring 2018; future enrollment planned) Adult students at the University of Minnesota who are enrolled in the Research Experience Points (REP) program may enroll in this study to be awarded points for class credit. We will request that participants complete the study in a quiet environment free of distractions with a reliable internet connection, and that they do not participate if they have consumed alcohol or illicit substances in the last 8 hours/are under the influence of illicit substances. We will also recommend the use of over-the-ear headphones for the study. Participants will complete an online consent form independently, though they may contact research staff at any time if they have questions. After completing the consent form, participants will be redirected to the COMPAS self-report measures. After the assessment suite is complete, the participants will be automatically re-directed to the Posit Science website to complete the assessment battery. Total participation should take approximately 45-60 minutes.

Phase 4: Pilot Adolescent Cognitive Training (Enrollment period: Summer 2018. CLOSED TO ENROLLMENT) We will recruit adolescents without a mental health diagnosis and with a diagnosis of anxiety by using the UMP Psychiatry Clinic recruitment registry, contacting previous research participants, by advertising in the community and online (Facebook and Department website). Parents/guardians will be asked to provide a brief demographic and medical history about their child. If the participant is over 18, they may complete this independently, but are instructed that they can work with their parent or guardian if they choose to do so. The adolescent will then complete the assessment battery, 4 hours of BrainHQ training games over 2 weeks, and repeat the assessment battery. Total participation should last approximate 5 hours and will be completed entirely remotely. Participants will receive their compensation via email, using the same account that was used for sending the link to the battery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1271
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

Phase 1 Inclusion Criteria:

• Aged 18-65

• Willing and able to provide informed consent as determined by the REDCap assessment

• Fluent in English (learned before the age of 12)

• Has reliable internet access and a device such as a laptop or iPad which can be used to connect to the BrainHQ portal in a quiet place free of distraction

• Able to use an iPad or computer to perform visual and auditory cognitive assessments unassisted

• No history of schizophrenia, bipolar disorder with psychosis, or schizoaffective disorder

• No neurological disorder, major head injury, mental retardation diagnosis, or autism spectrum disorder

• Pregnant women may participate in this study

Phase 2 Inclusion Criteria:

• Aged 18-80

• Willing and able to provide informed consent

• Learned English before the age of 12

• Pregnant women may participate in this study

• Able to use an iPad to perform visual and/or auditory cognitive assessments unassisted.

Phase 3 Inclusion Criteria:

• Aged 18-35

• Willing and able to provide informed consent Fluent in English Able to use an iPad or computer to perform visual and auditory cognitive assessments unassisted

• Has reliable internet access and a device such as a laptop or iPad which can be used to connect to the REDCap server and BrainHQ portal in a quiet place free of distraction

Phase 4 Inclusion Criteria:

• Aged 12-18

• Either has no mental health diagnosis (healthy control) or is diagnosed with an anxiety disorder

• Willing and able to provide assent; at least one parent or guardian is able to provide written consent for participation

• Fluent in English

• Consistent access to a device with the iOS operating system (e.g., iPhone, iPad)

• Able to use an iOS device to perform visual and auditory cognitive assessments unassisted

• Has reliable internet access in a quiet place free from distraction to complete study activities

Exclusion Criteria for all participants:

• Unable or unwilling to provide informed consent

• Not fluent in written/spoken English

• Unable to use an iPad or computer to complete visual and/or auditory cognitive assessments without assistance

• Presence of a medical or behavioral condition that would prohibit participation in the trial

• Participant has used illicit substances or alcohol within the past 8 hours

Related Conditions & MeSH terms

• Cognition

Intervention

Behavioral:
• Cognitive Assessments (Phase 1)
Participants will participate in up to 6 assessments in 4 domains of cognition: Processing Speed; Executive Attention; Learning and Memory; and Social Cognition. Assessments: Visual Sweeps Sustained Visual Attention Associative Learning--Visual Associative Learning--Auditory Emotion Motion Voice Choice
• Cognitive Battery A (Phase 2)
Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant will complete self-report surveys. Assessments: On trails: Learning Line Length Discrimination Tap the Emotion Sound Sweeps BIS/BAS TEPS Feasibility survey
• Cognitive Battery B (Phase 2)
Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant will complete the complete self-report surveys. Assessments: Visual Time Order Judgment Target Tracker Emotional Face Auditory Sound Discrimination BIS/BAS TEPS Feasiblity assessment
• Cognitive Battery C (Phase 2)
Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant willcomplete self-report surveys. Assessments: Stroop 2AFC Visual Task Switcher Beep Seeker Voice Choice BIS/BAS TEPS Feasibility Survey

Locations

Country	Name	City	State
United States	University of Minnesota, Dept of Psychiatry	Minneapolis	Minnesota
United States	University of California San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	Posit Science Corporation, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Sweeps	Phase 1: Participants watch two spatial frequency sweeps and determine whether each one swept inward or outward	4 minutes
Primary	Sustained Visual Attention	Phase 1: Participants are asked to press the spacebar as fast as they can whenever a star appears at the top of the screen (don't press when it appears at the bottom of the screen)	4 minutes
Primary	Associative Learning--Visual	Phase 1: Participants will see a ring of items. They are asked to memorize the items and their locations.	4 minutes
Primary	Associative Learning--Auditory	Phase 1: Participants will hear a sequence of syllables. They are asked to memorize the syllables and repeat the sequence by clicking on the words.	4 minutes
Primary	Emotion Motion	Phase 1: Participants will see a video of a person showing a facial expression on every trial. They are asked to select the correct emotion	4 Minutes
Primary	Voice Choice	Phase 1: A sentence spoken in a certain prosody will be presented on every trial. Correctly choose the emotion expressed in the sentence	4 Minutes
Primary	On Trails: Learning	Phase 2, Battery A: Participants see two circles connected by paths. Remember the path from A to B, and click the circles in the order indicated. If the participant makes a mistake, the path is shown again.	4 minutes
Primary	Line Length Discrimination	Phase 2, Battery A: Participants watch two lines surrounded by stars and determine which one is longer.	4 minutes
Primary	Tap the Emotion	Phase 2, Battery A: This is an executive function go/no-go task that captures both inhibitory control and sustained attention abilities. Participants see a series of faces, each presented for a limited time. Participants are instructed to tap the button every time they see a happy or sad face, and to not tap the button when they see a neutral face	4 minutes
Primary	Sound Sweeps	Phase 2, Battery A: Participants are presented with two subsequent tones that eithe rrise or lower in pitch, and they are asked to identify the direction of the pitch change.	4 minutes
Primary	Visual Time Order Judgment	Phase 2, Battery B: Watch two visual patterns shown one after the other and determine which one was presented first	4 minutes
Primary	Target Tracker	Phase 2, Battery B: Keep track of the targets as all the objects (targets and distractors) move around the screen.	4 minutes
Primary	Emotional Face	Phase 2, Battery B: This is an emotional stroop task that provides a measure of executive attention. In each trial, an expressive face is shown and overlaid with a congruent or incongruent word (stroop effect). Participants see a series of faces, each presented for a limited time. Identify the emotion of the face as quickly as possible. If the face is displaying happiness, tap the HAPPY button. If the face is displaying fear, tap the FEAR button. Increased reaction time to incongruent stimulus combinations capture capacity for conflict resolution.	4 minutes
Primary	Auditory Sound Discrimination	Phase 2, Battery B: Participants must determine which of two similar sounding syllable phonemes were spoken.	4 minutes
Primary	Stroop 2AFC	Phase 2, Battery C: The name of a color written in colored text appears in the screen. Participants elect the color of the text by tapping left/right keyboard arrow as quickly as they can.	4 minutes
Primary	Visual Task Switcher	Phase 2, Battery C: Two shapes are presented rapidly on the screen. Respond quickly if the two shapes share the same criteria, which changes from trial to trial (e.g., color).	4 minutes
Primary	Beep Seeker	Phase 2, Battery C: Participants are presented with a target beep tone and then asked to identify it in the presence of distracting tones.	4 minutes
Primary	Voice Choice	Phase 2, Battery C: A sentence spoken in a certain prosody will be presented on every trial. Correctly choose the emotion expressed in the sentence	4 minutes
Secondary	Behavioral Inhibition Scale/Behavioral Activation Scale (BIS/BAS)	Participants will answer self-report questions to determine behavioral inhibition and behavioral activation. The scale is set at 1-4 1 not active at all and 5 being the most active	4 minutes
Secondary	Temporal Experience of Pleasure Scale (TEPS)	Participants will answer self-report questions to determine their anticipatory and consummatory pleasure. Scale range is 1-6 1 being least pleasurable and 6 being the most pleasurable	4 minutes
Secondary	Feasibility ratings	Participants will answer self report questions about the accessibility of the Posit Science cognitive assessments.	1 minute