Is Cognitive Training an Option?

Sponsor
Alliant International University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05352568
Collaborator
(none)
30
1
1
7.2
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Training
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pre-test/post-test pre-experimental design with convenience and snowball sampling.Pre-test/post-test pre-experimental design with convenience and snowball sampling.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Is Cognitive Training an Option? Understanding the Feasibility of Cognitive Training With Individuals Living With Schizophrenia
Actual Study Start Date :
May 2, 2022
Anticipated Primary Completion Date :
Oct 2, 2022
Anticipated Study Completion Date :
Dec 7, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitive Group

Computer Cognitive-Based Training

Behavioral: Cognitive Training
Computer-Based Cognitive Training from BrainHQ (Posit Science)

Outcome Measures

Primary Outcome Measures

  1. Montreal Cognitive Assessment (MoCA) [10-15 minutes]

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

Secondary Outcome Measures

  1. Davos Assessment of Cognitive Biases Scale (DACOBS) [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 [5-15 minutes]

    A psychosocial functioning assessment for individuals with schizophrenia.

  3. Multidimensional Schizotypy Scale - Brief Version (MSS-B) [10-15 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 View Heights Convalescent Hospital Los Angeles California United States 90061

Sponsors and Collaborators

  • Alliant International University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andre Pierre Longino, M.A., Researcher, Alliant International University
ClinicalTrials.gov Identifier:
NCT05352568
Other Study ID Numbers:
  • 2105211050
First Posted:
Apr 29, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andre Pierre Longino, M.A., Researcher, Alliant International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022