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Mechanisms of Cognitive Change (CTCS)

Primary Purpose

Psychosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation
Active Control
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychosis

Eligibility Criteria

15 Years - 100 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Colorado State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Remediation

Active Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Academic Performance
Academic performance will be evaluated using participant grade point average improvement over the course of the study.

Full Information

First Posted
September 20, 2019
Last Updated
September 21, 2022
Sponsor
Colorado State University
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1. Study Identification

Unique Protocol Identification Number
NCT04103775
Brief Title
Mechanisms of Cognitive Change
Acronym
CTCS
Official Title
Mechanisms of Cognitive Change
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment and intervention halted due to Covid-19 pandemic.
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
January 22, 2021 (Actual)
Study Completion Date
January 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Remediation
Arm Type
Experimental
Arm Description
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
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Intervention Description
See Cognitive Remediation Arm description.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
See Active Control Arm description.
Primary Outcome Measure Information:
Title
MATRICS Consensus Cognitive Battery (MCCB) Verbal Learning Subscale Scores
Description
Change in MATRICS Consensus Cognitive Battery (MCCB) Verbal Learning Subscale. Demographically corrected T-scores (M = 50; SD = 10; higher better).
Time Frame
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 Measure Information:
Title
Academic Performance
Description
Academic performance will be evaluated using participant grade point average improvement over the course of the study.
Time Frame
Semester data obtained yearly up to 8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mechanisms of Cognitive Change

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