Mechanisms of Cognitive Change

NCT ID: NCT04103775

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2021-01-22

Brief Summary

This study will determine whether targeted cognitive training, a low-cost and low-risk commercial cognitive remediation therapy, directly impacts therapeutic targets as well as secondary outcomes in college undergraduates. The active intervention will be compared to an active control condition (computer games). Participants will also attend CSU TILT (The Institute for Teaching and Learning) Academic Workshops.

Detailed Description

The primary goal of this project is to investigate whether commercial cognitive remediation therapy improves cognitive functioning in college undergraduates. The secondary goal is to investigate neurophysiological, cognitive, and psychosocial mechanisms of change. The investigators will compare cognitive remediation therapy to computer games. The active control condition will allow the investigators to determine whether targeted cognitive training, as an adjunct to academic skills training provided by CSU TILT, provides significant improvement over computer games alone (which is also thought to provide some value as "brain training"). Participants who agree to enroll in the study will be randomized to one of two intervention arms: cognitive remediation (CR) or active control (AC). In the CR arm, participants will complete 20 hours of targeted cognitive training, in 30-min session, 5 days per week, over 8 weeks. The AC Arm will follow the same schedule, except that participants will complete video games (e.g., pong). All participants will repeat assessments at randomly determined midpoint, as well as after the 8 weeks of training have been completed.

Conditions

Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cognitive Remediation

Cognitive Remediation comprises of six exercises supplied by BrainHQ by Posit Science Corporation: Sound Sweeps (targets auditory processing speed): Two successive frequency-modulated tone sweeps are presented and participants indicate whether the frequency increased or decreased within each tone: Fine Tuning (targets auditory perception and processing speed): Participants indicate which one of two confusable syllables were presented; Syllable Stacks (targets auditory memory); Users report the order of presented syllables in a serial memory span task; Memory Grid (targets auditory memory); Participants match identical cards representing syllables; To do List Training (targets auditory memory): Participants see a g rid of everyday items (e.g., plant, carrots, shovel) and select the items in accordance with spoken instructions; Rhythm Recall (target auditory memory): Participants recreate auditory melodies

Group Type: EXPERIMENTAL

Cognitive Remediation

Intervention Type: BEHAVIORAL

See Cognitive Remediation Arm description.

Active Control

Active Control Comprises six exercises also supplied by Post Science Corporation: A Maze Race, Reversi, Bricks Breaking Hex, Word Search II, Bricks Squasher II, and CircloO. These are all common computer games freely offered online.

Group Type: ACTIVE_COMPARATOR

Active Control

Intervention Type: BEHAVIORAL

See Active Control Arm description.

Interventions

Cognitive Remediation

See Cognitive Remediation Arm description.

Intervention Type: BEHAVIORAL

Active Control

See Active Control Arm description.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• College undergraduate;
• English fluency, and the ability to complete study requirements.

Exclusion Criteria

• College seniors (i.e., students with more than 89 credits at CSU);
• Students who are concurrently enrolled in another study investigating the efficacy or effectiveness of novel learning or cognitive development techniques (not including tutoring or other existing programs available to CSU undergraduates);
• Participants less than age 15.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Michael L Thomas

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Colorado State University

Fort Collins, Colorado, United States

Countries

United States

Other Identifiers

19-8509H

Identifier Type: -

Identifier Source: org_study_id