NCT07326618

Brief Summary

Virtual reality (VR) is a novel and innovative intervention method increasingly used in psychiatric research and treatment. VR allows individuals to experience realistic, everyday social situations in a safe and controlled environment. This study aims to examine the effects of a cinematic VR-based psychosocial intervention on individuals with schizophrenia who experience reduced psychosocial functioning and social isolation. In this study, a Cinematic Virtual Reality Treatment Program (cVR-PTP) consisting of 12 weekly sessions was developed. Each session focuses on real-life social situations designed to support social interaction and daily functioning. The intervention aims to contribute to improvements in psychosocial functioning, social engagement, and overall functioning in individuals with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable schizophrenia

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

December 24, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

schizophreniavirtual realitypsychosocial functioningsocial cognitionneurocognitionsense of presence

Outcome Measures

Primary Outcomes (2)

  • Psychososcial Functioning

    Psychosocial functioning refers to an individual's ability to interact with their environment and to perform effectively in various social roles, such as being an employee, student, spouse, family member, or friend. This definition also encompasses individuals' capacity to fulfill these roles, engage in self-care, and derive satisfaction from leisure and recreational activities. In order to measure psychososcial functioning in detail, Social Functioning Scale (SFS) was used. SFS is a self-report scale that aims to measure social functioning in schizophrenia considering the period of last three months. The scale has seven specific areas of social functioning including social engagement/withdrawal, interpersonal behavior, recreation, pro-social activities, independence-performance, independence-competence and employment.

    3 months

  • Psychosocial Functioning

    In order to measure psychosocil functioning, Personal and Social Performance Scale (PSP) was used. PSP is an interview-based evaluation scale. It provides an assessment in functioning across four dimensions including socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors. Each dimension is rated at six levels (absent, mild, manifest but not marked, marked, severe, very severe). Although each dimension is rated individually, a single score of social functioning is obtained ranging from 0 to 100. Higher score indicates better functioning.

    4 weeks

Secondary Outcomes (1)

  • Sense of Presence

    1 week

Study Arms (2)

Cinematic Virtual Reality Psychososcial Treatment Program Group

EXPERIMENTAL

Participants received cinematic VR sessions in this group on a weekly basis during 12 weeks

Behavioral: Cinematic Virtual Reality Psychososcial Treatment Program Group

Control Group - Face to Face Interviews

NO INTERVENTION

This group consists of individuals with schizophrenia. Participants in this group did not receive the virtual reality intervention. They participated in weekly face-to-face, non-interventional interviews as part of treatment as usual for 12 weeks on a weekly basis.

Interventions

cVR-PTP 1. Week - Orientation to the Virtual Environment: Ability to use the VR headset, visual-spatial awareness related to the virtual environment 2. Week - Orientation to the Virtual Environment: Ability to use the VR headset, visual-spatial awareness related to the virtual environment 3. Week - Self-Care: Waking up in the morning, taking a shower 4. Week - Social Interaction: Waiting at a crowded public transport stop, interacting with others 5. Week - Mobility: Traveling with others on a tram 6. Week - Mobility: Traveling with others on a ferry 7. Week - Mobility and Daily Living Activities: Shopping at a traditional bazaar 8. Week - Social Interaction: Going alone to a café 9. Week - Daily Living Activities: Experiencing a grocery shopping 10. Week - Independent Time Activities - Social Interaction: Participating in a cooking workshop 11. Week - Social Interaction: watching aTV show with others 12. Week - Social Interaction: Being in a pleasant family and friends setting

Also known as: cVR-PTP
Cinematic Virtual Reality Psychososcial Treatment Program Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical stability over the past 12 weeks
  • No changes in antipsychotic medication during last 6 monhts
  • Having a score ≤70 on the PSP and and ≤61 on the Social and Occupational Functioning Assessment Scale (SOFAS)

You may not qualify if:

  • Experienced a psychotic episode or suicide attempt in the past 12 weeks
  • Received electroconvulsive therapy in the past 6 months
  • Having a diagnosis of a serious physical or neurological disorder that could impact clinical functioning or sensory systems (visual or auditory), alcohol or substance use disorder, intellectual disability, or a history of epilepsy
  • Participants with an identified suicide risk, self-harm tendencies, or violent behavior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatry

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related Publications (6)

  • Bell, I.H., Pot-Kolder, R., Rizzo, A. et al. Advances in the use of virtual reality to treat mental health conditions. Nat Rev Psychol 3, 552-567 (2024). https://doi.org/10.1038/s44159-024-00334-9

    BACKGROUND
  • Witmer B. G., Jerome C. J. and Singer M. J. , "The Factor Structure of the Presence Questionnaire," in Presence, vol. 14, no. 3, pp. 298-312, June 2005, doi: 10.1162/105474605323384654.

    BACKGROUND
  • Priebe S. Social outcomes in schizophrenia. Br J Psychiatry Suppl. 2007 Aug;50:s15-20. doi: 10.1192/bjp.191.50.s15.

    PMID: 18019039BACKGROUND
  • Bosc M. Assessment of social functioning in depression. Compr Psychiatry. 2000 Jan-Feb;41(1):63-9. doi: 10.1016/s0010-440x(00)90133-0.

    PMID: 10646621BACKGROUND
  • Schroeder AH, Bogie BJM, Rahman TT, Therond A, Matheson H, Guimond S. Feasibility and Efficacy of Virtual Reality Interventions to Improve Psychosocial Functioning in Psychosis: Systematic Review. JMIR Ment Health. 2022 Feb 18;9(2):e28502. doi: 10.2196/28502.

    PMID: 35179501BACKGROUND
  • Wiebe A, Kannen K, Selaskowski B, Mehren A, Thone AK, Pramme L, Blumenthal N, Li M, Asche L, Jonas S, Bey K, Schulze M, Steffens M, Pensel MC, Guth M, Rohlfsen F, Ekhlas M, Lugering H, Fileccia H, Pakos J, Lux S, Philipsen A, Braun N. Virtual reality in the diagnostic and therapy for mental disorders: A systematic review. Clin Psychol Rev. 2022 Dec;98:102213. doi: 10.1016/j.cpr.2022.102213. Epub 2022 Oct 30.

    PMID: 36356351BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Köksal Alptekin, MD, Professor

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR
  • Faik Kartelli, PhD

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The rater of Personal and Social Performance Scale was blinded to the group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The experimental group received received a cinematic virtual reality-based psychosocial intervention during 12 weeks on a weekly basis. The intervention consisted of different cinematic VR sessions delivered weekly. Sessions were designed to address psychosocial functioning, social interaction, and daily functioning. Participants continued to have their usual medical treatment. The control group also consisted of individuals with schizophrenia. Participants in this group did not receive the virtual reality intervention and they continued to receive treatment as usual throughout the study period. They participated in weekly face-to-face, non-interventional interviews during 12 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 8, 2026

Study Start

April 12, 2023

Primary Completion

March 15, 2024

Study Completion

September 17, 2024

Last Updated

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

De-identified individual participant data that underlie the results reported in this study will be shared upon reasonable request to the corresponding author, beginning after publication of the primary results.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations