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Is Cognitive Training an Option?

Primary Purpose

Schizophrenia, Schizoaffective, Cognition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Sponsored by
Alliant International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective, Cognition, Social Cognition, Psychosocial Function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • View Heights Convalescent Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Group

Arm Description

Computer Cognitive-Based Training

Outcomes

Primary Outcome Measures

Montreal Cognitive Assessment (MoCA)
A quick screening tool for mild cognitive impairments (MCI) and early Alzheimer's dementia.

Secondary Outcome Measures

Davos Assessment of Cognitive Biases Scale (DACOBS)
A self-report measure of cognitive biases and cognitive limitations that contributes to psychosis.
Illness Management and Recovery Scale - Consumer Self-Rating, IMRS
A psychosocial functioning assessment for individuals with schizophrenia.
Multidimensional Schizotypy Scale - Brief Version (MSS-B)
A symptomology assessment with a subscale consisting of positive, negative, and disorganized dimensions of schizotypy.

Full Information

First Posted
June 14, 2021
Last Updated
August 20, 2023
Sponsor
Alliant International University
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1. Study Identification

Unique Protocol Identification Number
NCT05352568
Brief Title
Is Cognitive Training an Option?
Official Title
Is Cognitive Training an Option? Understanding the Feasibility of Cognitive Training With Individuals Living With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alliant International 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective, Cognition
Keywords
Schizophrenia, Schizoaffective, Cognition, Social Cognition, Psychosocial Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-test/post-test pre-experimental design with convenience and snowball sampling.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Group
Arm Type
Experimental
Arm Description
Computer Cognitive-Based Training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Computer-Based Cognitive Training from BrainHQ (Posit Science)
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
A quick screening tool for mild cognitive impairments (MCI) and early Alzheimer's dementia.
Time Frame
10-15 minutes
Secondary Outcome Measure Information:
Title
Davos Assessment of Cognitive Biases Scale (DACOBS)
Description
A self-report measure of cognitive biases and cognitive limitations that contributes to psychosis.
Time Frame
15-20 minutes
Title
Illness Management and Recovery Scale - Consumer Self-Rating, IMRS
Description
A psychosocial functioning assessment for individuals with schizophrenia.
Time Frame
5-15 minutes
Title
Multidimensional Schizotypy Scale - Brief Version (MSS-B)
Description
A symptomology assessment with a subscale consisting of positive, negative, and disorganized dimensions of schizotypy.
Time Frame
10-15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
View Heights Convalescent Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90061
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Is Cognitive Training an Option?

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