NCT05830903

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
8mo left

Started Jan 2020

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2020Dec 2026

First Submitted

Initial submission to the registry

July 4, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

7 years

First QC Date

July 4, 2019

Last Update Submit

February 24, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (4)

Mild ED/NS

EXPERIMENTAL

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

Behavioral: VR-assisted occupational training

Mild ED/Severe NS

EXPERIMENTAL

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

Behavioral: VR-assisted occupational training

Severe ED/Mild NS

EXPERIMENTAL

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

Behavioral: VR-assisted occupational training

Severe ED/NS

EXPERIMENTAL

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

Behavioral: VR-assisted occupational training

Interventions

VR-assisted occupational training

Mild ED/NSMild ED/Severe NSSevere ED/Mild NSSevere ED/NS

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

SchizophreniaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Study Officials

  • Yi Ling Chien

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2019

First Posted

April 26, 2023

Study Start

January 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations