NCT05352568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2021

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 2, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

June 14, 2021

Last Update Submit

August 20, 2023

Conditions

Keywords

SchizophreniaSchizoaffectiveCognitionSocial CognitionPsychosocial Function

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA)

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

    10-15 minutes

Secondary Outcomes (3)

  • Davos Assessment of Cognitive Biases Scale (DACOBS)

    15-20 minutes

  • Illness Management and Recovery Scale - Consumer Self-Rating, IMRS

    5-15 minutes

  • Multidimensional Schizotypy Scale - Brief Version (MSS-B)

    10-15 minutes

Study Arms (1)

Cognitive Group

EXPERIMENTAL

Computer Cognitive-Based Training

Behavioral: Cognitive Training

Interventions

Computer-Based Cognitive Training from BrainHQ (Posit Science)

Cognitive Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

View Heights Convalescent Hospital

Los Angeles, California, 90061, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pre-test/post-test pre-experimental design with convenience and snowball sampling.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

June 14, 2021

First Posted

April 29, 2022

Study Start

May 2, 2022

Primary Completion

March 1, 2023

Study Completion

June 30, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations