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

Establish a novel vocational training program and test its validity in a pilot study.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Cognitive Impairment
• Intervention / Treatment: Behavioral: VR-assisted occupational training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Ling Chien; Phone Number: 66013 886-2-2312-3456; Email: ylchien@hotmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yi Ling Chien, M.D., Ph.D.; Phone Number: 66013 886-2-2312-3456; Email: ylchien@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild ED/NS; 10 patients with mild or none executive function impairment and mild or none negative symptoms.	Behavioral: VR-assisted occupational training; VR-assisted occupational training
Experimental: Mild ED/Severe NS; 10 patients with mild or none executive function impairment and severe or moderate negative symptoms.	Behavioral: VR-assisted occupational training; VR-assisted occupational training
Experimental: Severe ED/Mild NS; 10 patients with severe or moderate executive function impairment and mild or none negative symptoms.	Behavioral: VR-assisted occupational training; VR-assisted occupational training
Experimental: Severe ED/NS; 10 patients with severe or moderate executive function impairment and severe or moderate negative symptoms.	Behavioral: VR-assisted occupational training; VR-assisted occupational training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks
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	8 weeks
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.	8 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yi Ling Chien, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 201904105RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No