NCT07111689

Brief Summary

This study was conducted to examine the effect of virtual reality intervention, given in addition to conventional occupational therapy intervention, on general cognitive functions (attention, orientation, memory, visual skills, visual-motor skills, praxis, executive functions, etc.) in individuals with schizophrenia. This study was designed in accordance with the CONSORT statement, which standardizes randomized controlled trials. Additionally, the study was approved by a university's scientific research ethics committee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

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

Study Start

First participant enrolled

April 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 1, 2025

Last Update Submit

August 1, 2025

Conditions

Keywords

schizopreniavirtual realitycognitive

Outcome Measures

Primary Outcomes (1)

  • The Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)

    The LOTCA is a performance test that consists of 20 items. The test includes testing materials such as card decks, colored blocks, a pegboard set, and other items. Additionally, a manual is provided that defines the cognitive domains assessed and provides administration instructions, and specific scoring guidelines. The LOTCA was scored on a Likert-type scale from 1 to 4, except for items 1-5 which related to categorization, unstructured Risk Object Classification, and structured Risk Object Classification. Higher scores indicate better cognitive functions

    1 hour

Study Arms (2)

Control Group

EXPERIMENTAL

cognitive rehabilitation with conventional occupational therapy intervention

Behavioral: Conventional Occupational Therapy Interventiın

Study Group

EXPERIMENTAL

virtual reality intervention in addition to conventional occupational therapy intervention

Behavioral: Conventional Occupational Therapy InterventiınBehavioral: Virtual Reality İntervention

Interventions

1-2. Week: Occupation-based interventions for visual skills 3-6. Week: Social Skills Training 7-8. Week: Interventions for participation problems in ADLs

Control GroupStudy Group

In this study, the Xbox 360 gaming console and Kinect sensor were utilized for the virtual reality (VR) intervention. The Xbox 360 functions as an interactive gaming platform, while the Kinect sensor is a motion-detection device that captures users' positions and movements through an integrated camera and sensors. The selection of games for the VR intervention was conducted in collaboration with experts from various disciplines. The evaluation process considered the cognitive and functional demands required for successful gameplay, the potential skills each game could enhance, and the overall therapeutic purpose of the selected games. Following an independent assessment of each game, nine games were identified as suitable for the intervention. Given that all selected games shared similar functional requirements, participants were provided access to the full set of games to optimize engagement and motivation.

Study Group

Eligibility Criteria

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

You may qualify if:

  • (1) age between 18 and 65 years,
  • (2) Participants must have been diagnosed with Schizophrenia according to the ICD-10 diagnostic criteria,
  • (3) Participants must be able to read and write at a level that will allow them to understand the content of the study,
  • (4) There must be no severe cognitive impairment diagnosed that would prevent participation in the study,
  • (5) Participants' antipsychotic treatments must be stable (no medication changes in the last 3 months),
  • (6) Participants must be competent to provide informed consent

You may not qualify if:

  • (1) Existence of additional diagnoses such as schizoaffective disorder, bipolar disorder or severe depressive disorder,
  • (2) Existence of active substance or alcohol addiction diagnosed in the last 6 months,
  • (3) Presence of diseases that may affect cognitive functions such as epilepsy, dementia, Parkinson's disease,
  • (6) For female participants, there is pregnancy or breastfeeding,
  • (7) There are conditions such as visual or hearing impairment that may prevent active participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Science

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 8, 2025

Study Start

April 1, 2023

Primary Completion

October 21, 2023

Study Completion

June 13, 2024

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations