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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05830903
Collaborator
(none)
40
1
4
48
0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: VR-assisted occupational training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. clinical ratings of schizophrenia symptoms [8 weeks]

    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.

  2. vocational skills [8 weeks]

    Based on Smith et al.' study, job interview role-play performance will be scored across nine domains: (1) conveying oneself as a hard worker, (2) sounding easy to work with, (3) conveying that one behaves professionally, (4) negotiation skills (requesting one day off), (5) sharing things in a positive way, (6) sounding honest, (7) sounding interested in the position, (8) comfort level, and (9) establishing rapport

  3. global improvement [8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Having a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders -5th version, onset within 10 years.

  2. Aged between 20 and 40 years.

  3. Motivated to have a job.

  4. Having a full-scale IQ > 70 on the Wechsler Adult Intelligence Scale-version IV.

(6) Having a PANSS positive scale < 70, indicating a stable condition during the illness course.

Exclusion Criteria:
  1. Comorbid with other major psychiatric disorders (i.e., bipolar disorders) or neurological diseases.

  2. Substance abuse within one year.

  3. Visual impairment and/or hearing impairment that would preclude participation in the VR-based training program.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05830903
Other Study ID Numbers:
  • 201904105RINB
First Posted:
Apr 26, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2023