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Completed

NCT Number: NCT05352568

Is Cognitive Training an Option?

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

View Heights Convalescent Hospital

Los Angeles, California, 90061, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive training

Behavioral

Computer-Based Cognitive Training from BrainHQ (Posit Science)

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: 10-15 minutes

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

Secondary outcomes

  1. Davos Assessment of Cognitive Biases Scale (DACOBS)

    Time frame: 15-20 minutes

    A self-report measure of cognitive biases and cognitive limitations that contributes to psychosis.

  2. Illness Management and Recovery Scale - Consumer Self-Rating, IMRS

    Time frame: 5-15 minutes

    A psychosocial functioning assessment for individuals with schizophrenia.

  3. Multidimensional Schizotypy Scale - Brief Version (MSS-B)

    Time frame: 10-15 minutes

    A symptomology assessment with a subscale consisting of positive, negative, and disorganized dimensions of schizotypy.

Sponsors and collaborators

Lead sponsor

Alliant International University

Other

Registry information

Official study title

Is Cognitive Training an Option? Understanding the Feasibility of Cognitive Training With Individuals Living With Schizophrenia

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2022
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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