D2D Normative Data for Remote Assessments

NCT03206775 | Completed

• 1 other identifier: STUDY00000319
• Study Type: observational
• Target: 1,271
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cognition

Keywords

cognitive training; Self-report assessments; Normative Data

Outcome Measures

Primary Outcomes (18)

• Visual Sweeps

  Phase 1: Participants watch two spatial frequency sweeps and determine whether each one swept inward or outward

  4 minutes

• 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

• Associative Learning--Visual

  Phase 1: Participants will see a ring of items. They are asked to memorize the items and their locations.

  4 minutes

• 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

• 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

• 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

• 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

• Line Length Discrimination

  Phase 2, Battery A: Participants watch two lines surrounded by stars and determine which one is longer.

  4 minutes

• 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

• 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

• 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

• Target Tracker

  Phase 2, Battery B: Keep track of the targets as all the objects (targets and distractors) move around the screen.

  4 minutes

• 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

• Auditory Sound Discrimination

  Phase 2, Battery B: Participants must determine which of two similar sounding syllable phonemes were spoken.

  4 minutes

• 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

• 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

• 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

• 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 Outcomes (3)

• Behavioral Inhibition Scale/Behavioral Activation Scale (BIS/BAS)

  4 minutes

• Temporal Experience of Pleasure Scale (TEPS)

  4 minutes

• Feasibility ratings

  1 minute

Study Arms (9)

Healthy controls (Phase 1)

Participants will participate in Cognitive Assessments (Phase 1) developed by Posit Science

Behavioral: Cognitive Assessments (Phase 1)

Healthy Controls, Battery A (Phase 2)

Participants will complete the Cognitive Battery A (Phase 2) developed by Posit Science while at the Minnesota State Fair.

Behavioral: Cognitive Battery A (Phase 2)

Healthy Controls, Battery B (Phase 2)

Participants will complete the Cognitive Battery B (Phase 2) developed by Posit Science while at the Minnesota State Fair.

Behavioral: Cognitive Battery B (Phase 2)

Healthy Controls, Battery C (Phase 2)

Participants will complete the Cognitive Battery C (Phase 2) developed by Posit Science while at the Minnesota State Fair.

Behavioral: Cognitive Battery C (Phase 2)

Healthy Controls (Phase 3)

Participants will complete the full Posit Science cognitive assessment battery and self-report questionnaires for credit in the Research Experience Program at the University of Minnesota.

Healthy Controls, Battery D (Phase 2)

Participants will complete the Cognitive Battery E (Phase 2) developed by Posit Science while at the Minnesota State Fair.

Healthy Controls, Battery E (Phase 2)

Participants will complete the Cognitive Battery C (Phase 2) developed by Posit Science while at the Minnesota State Fair.

Adolescents with anxiety diagnosis (Phase 4)

Participants will complete remote cognitive assessments and cognitive training programs developed by Posit Science.

Adolescents, healthy controls (Phase 4)

Participants will complete remote cognitive assessments and cognitive training programs developed by Posit Science.

Interventions

Cognitive Assessments (Phase 1) BEHAVIORAL

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

Healthy controls (Phase 1)

Cognitive Battery A (Phase 2) BEHAVIORAL

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

Healthy Controls, Battery A (Phase 2)

Cognitive Battery B (Phase 2) BEHAVIORAL

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

Healthy Controls, Battery B (Phase 2)

Cognitive Battery C (Phase 2) BEHAVIORAL

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

Healthy Controls, Battery C (Phase 2)

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Phase 1: Participants in this study will be healthy adults, aged 18-65, who are fluent in English and do not have a history of schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, autism spectrum disorder, mental retardation, neurological disorder, or history of major head injury. Participants will not be restricted by their geological location as they can access the study portal remotely with a reliable internet connection. Pregnant women may participate in this study. Phase 2: Participants in this study will be attendants of the Minnesota State Fair, aged 18-80, who learned English before the age of 12 and can use an iPad without assistance. Participants may be pregnant or have a medical, developmental, psychiatric, or neurological condition.

You may qualify if:

• 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
• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• University of California, San Francisco: collaborator
• Posit Science Corporation: collaborator

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143, United States

Location

University of Minnesota, Dept of Psychiatry

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Interventions

Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sophia Vinogradov, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 2, 2017
• Study Start: June 6, 2017
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

US (2)