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Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques

Primary Purpose

Schizophrenia, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
VR-assisted occupational training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Having a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders -5th version Aged between 20 and 55 years. Motivated to have a job. Having a full-scale IQ > 70 on the Wechsler Adult Intelligence Scale-version IV. Having a PANSS positive scale < 70, indicating a stable condition during the illness course. Exclusion Criteria: Comorbid with other major psychiatric disorders (i.e., bipolar disorders) or neurological diseases. Substance abuse within one year. Visual impairment and/or hearing impairment that would preclude participation in the VR-based training program.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Mild ED/NS

Mild ED/Severe NS

Severe ED/Mild NS

Severe ED/NS

Arm Description

10 patients with mild or none executive function impairment and mild or none negative symptoms.

10 patients with mild or none executive function impairment and severe or moderate negative symptoms.

10 patients with severe or moderate executive function impairment and mild or none negative symptoms.

10 patients with severe or moderate executive function impairment and severe or moderate negative symptoms.

Outcomes

Primary Outcome Measures

clinical ratings of schizophrenia symptoms
The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale completed by trained research staff. Scores for positive, negative, cognitive disorganization, emotional discomfort, and hostility/excitement symptoms were derived from factor-derived scoring published. * There are 30 different symptoms rated from 1 to 7 (total score of 210). Higher the score, worse the symptoms
vocational skills
Job interview role-play performance will be scored across nine domains: conveying oneself as a hard worker, sounding easy to work with, conveying that one behaves professionally, negotiation skills (requesting one day off), sharing things in a positive way, sounding honest, sounding interested in the position, comfort level, and establishing rapport
global improvement
Clinical Global Impression Improvement scale (CGI-I) rating scales are commonly used measures of symptom severity, treatment response and the efficacy in treatment studies of patients with mental disorders. It is a 7-point scale that require clinician to assess how much the patient's illness has improved or worsened relative to baseline. "1" meaning very much improved, "7" meaning very much worsen.

Secondary Outcome Measures

Full Information

First Posted
July 4, 2019
Last Updated
May 4, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05830903
Brief Title
Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques
Official Title
Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

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
Establish a novel vocational training program and test its validity in a pilot study.
Detailed Description
40 schizophrenia patients will be recruited to join the virtual reality based vocational training program, the training effect will be compared by interview skills and problem solving before and after the training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mild ED/NS
Arm Type
Experimental
Arm Description
10 patients with mild or none executive function impairment and mild or none negative symptoms.
Arm Title
Mild ED/Severe NS
Arm Type
Experimental
Arm Description
10 patients with mild or none executive function impairment and severe or moderate negative symptoms.
Arm Title
Severe ED/Mild NS
Arm Type
Experimental
Arm Description
10 patients with severe or moderate executive function impairment and mild or none negative symptoms.
Arm Title
Severe ED/NS
Arm Type
Experimental
Arm Description
10 patients with severe or moderate executive function impairment and severe or moderate negative symptoms.
Intervention Type
Behavioral
Intervention Name(s)
VR-assisted occupational training
Intervention Description
VR-assisted occupational training
Primary Outcome Measure Information:
Title
clinical ratings of schizophrenia symptoms
Description
The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale completed by trained research staff. Scores for positive, negative, cognitive disorganization, emotional discomfort, and hostility/excitement symptoms were derived from factor-derived scoring published. * There are 30 different symptoms rated from 1 to 7 (total score of 210). Higher the score, worse the symptoms
Time Frame
8 weeks
Title
vocational skills
Description
Job interview role-play performance will be scored across nine domains: conveying oneself as a hard worker, sounding easy to work with, conveying that one behaves professionally, negotiation skills (requesting one day off), sharing things in a positive way, sounding honest, sounding interested in the position, comfort level, and establishing rapport
Time Frame
8 weeks
Title
global improvement
Description
Clinical Global Impression Improvement scale (CGI-I) rating scales are commonly used measures of symptom severity, treatment response and the efficacy in treatment studies of patients with mental disorders. It is a 7-point scale that require clinician to assess how much the patient's illness has improved or worsened relative to baseline. "1" meaning very much improved, "7" meaning very much worsen.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders -5th version Aged between 20 and 55 years. Motivated to have a job. Having a full-scale IQ > 70 on the Wechsler Adult Intelligence Scale-version IV. Having a PANSS positive scale < 70, indicating a stable condition during the illness course. Exclusion Criteria: Comorbid with other major psychiatric disorders (i.e., bipolar disorders) or neurological diseases. Substance abuse within one year. Visual impairment and/or hearing impairment that would preclude participation in the VR-based training program.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Ling Chien
Phone
886-2-2312-3456
Ext
66013
Email
ylchien@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Ling Chien
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Ling Chien, M.D., Ph.D.
Phone
886-2-2312-3456
Ext
66013
Email
ylchien@hotmail.com

12. IPD Sharing Statement

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Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques

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