Mechanisms of Cognitive Change (CTCS)

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.

Study Overview

• Status: Terminated
• Conditions: Psychosis
• Intervention / Treatment: Behavioral: Cognitive Remediation; Behavioral: Active Control

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Colorado State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Cognitive Remediation; See Cognitive Remediation Arm description.
Active Comparator: 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.	Behavioral: Active Control; See Active Control Arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MATRICS Consensus Cognitive Battery (MCCB) Verbal Learning Subscale Scores	Change in MATRICS Consensus Cognitive Battery (MCCB) Verbal Learning Subscale. Demographically corrected T-scores (M = 50; SD = 10; higher better).	Three time points (1 week pre-randomization, mid-treatment [randomly selected for each participant between the 2nd and 7th week of treatment], and 1 week post-treatment) for all participants.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Academic Performance	Academic performance will be evaluated using participant grade point average improvement over the course of the study.	Semester data obtained yearly up to 8 years

Collaborators and Investigators

• Sponsor: Colorado State University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Actual): January 22, 2021
• Study Completion (Actual): January 22, 2021

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 19-8509H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No