Is Cognitive Training an Option?

NCT ID: NCT05352568

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2023-06-30

Brief Summary

The purpose of the study is to evaluate the feasibility of implementing cognitive training with 40 patients living with schizophrenia and schizoaffective disorder. The study aims to explore if cognitive training as an intervention can improve cognition, symptomology, social cognition, and psychosocial function which has been determined through literature to be impacted within this population. The results of this study will help shed light on utilizing additional resources to aid in decreasing relapse and continued hospitalizations.

Detailed Description

After being selected for this study based on a screening survey, participants will be asked to fill out a demographic questionnaire, the Multidimensional Schizotypy Scale - Brief Version (MSS-B), the Montreal Cognitive Assessment (MoCA), the Davos Assessment of Cognitive Biases Scale (DACOBS), and the Illness Management and Recovery Scale - Consumer Self-Rating, IMRS. The measurements evaluate different aspects of severe mental illness which are often challenges. This will take approximately: the screener questionnaire (2-3 minutes), demographic questionnaire (3-5 minutes), MSS-B (38 questions: 10-15 minutes), MoCA (10-15 minutes), DACOBS (42 questions: 15-20 minutes), and IMS (15 questions: 5 to 15 minutes)- Total Maximum Time is 63 minutes. After all, measurements are completed, the participants will be introduced to the BrainHQ program the following week. The participants will begin the selected cognitive training module 3 times a week (Mon, Wed, and Fri), 60 minutes per session for a total of 180 minutes per week. The participants will have a total of 24 sessions over the course of 8 weeks, for a total of 1,440 minutes of cognitive training over the course of this feasibility study. A process questionnaire on the acceptability/ feasibility of the cognitive training program will be administered after the first session, then the middle progress point (4th week), and at the end of the program (8th week) (2-3 minutes). Upon completion of the cognitive training, the participants will retake each measurement (MSS-B, MoCA, DACOBS, and IMRS)-Total Maximum Time is 55 minutes. There is minimal to no risk in this study. Participants will continue their prescribed treatment plan with the addition of the cognitive training which is computerized and takes the form of simulated games with an attended purpose. Participants will continue to be monitored by their providers and staff will continue to evaluate participants for changes in baseline behavior on a daily basis during the course of the study. The plan analysis for this study will be a MANOVA and Correlations. Confidentiality of research records and data will be protected in accordance with the Alliant International University Institutional Review Boards policies, and procedures.

Conditions

Schizophrenia; Schizoaffective; Cognition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Group

Computer Cognitive-Based Training

Group Type: EXPERIMENTAL

Cognitive Training

Intervention Type: BEHAVIORAL

Computer-Based Cognitive Training from BrainHQ (Posit Science)

Interventions

Cognitive Training

Computer-Based Cognitive Training from BrainHQ (Posit Science)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years and older
• A diagnosis of schizophrenia or schizoaffective disorder
• All genders
• All sexual orientations
• All class/ social-economic status
• All ethnicities

Exclusion Criteria

• An inability to understand the consent process and/or provide assent
• Inability to understand the assent form/process
• Not being a fluent English speaker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alliant International University

OTHER

Sponsor Role: lead

Responsible Party

Andre Pierre Longino, M.A.

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

View Heights Convalescent Hospital

Los Angeles, California, United States

Countries

United States

Other Identifiers

2105211050

Identifier Type: -

Identifier Source: org_study_id