Mechanisms of Cognitive Change

Psychosis Clinical Trial

— CTCS  

Official title:

Mechanisms of Cognitive Change

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04103775
• Other study ID #: 19-8509H
• Status: Terminated
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: January 22, 2021

Study information

• Verified date: September 2022
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Cognitive Remediation
See Cognitive Remediation Arm description.
• Active Control
See Active Control Arm description.

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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