Virtual Reality-Based Smoking Cessation Treatment in Patients With Schizophrenia

May 24, 2026 updated by: Emine Ilgın Hoşgelen, Dokuz Eylul University

Schizophrenia is associated with high rates of cigarette smoking, which contributes to serious physical health problems and reduced life expectancy. Existing smoking cessation treatments have shown limited long-term success in this population. Virtual Reality-based interventions may provide a new approach for supporting smoking cessation.

This study evaluated the effects of a 10-week virtual reality-based smoking cessation program in patients with schizophrenia and healthy smokers. Participants were assigned to either a virtual reality intervention group or a no-intervention control group. Smoking behavior, nicotine dependence, clinical symptoms, cognitive functioning, and quality of life were assessed before and after the intervention period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Schizophrenia is associated with elevated rates of cigarette smoking compared with the general population. Smoking is considered one of the major contributors to reduced life expectancy and increased physical morbidity in individuals with schizophrenia. Previous pharmacological and behavioral smoking cessation interventions have demonstrated limited effectiveness in this population, with low long-term abstinence rates and frequent relapse.

Virtual Reality has recently emerged as a promising therapeutic tool in mental health research. Studies conducted in non-clinical populations suggest that virtual reality-based interventions may support smoking cessation by providing immersive and controlled environments related to smoking behavior and craving management. However, there is currently limited research examining the effectiveness of virtual reality-based smoking cessation interventions in schizophrenia.

The present study investigated the effects of a 10-week virtual reality-based smoking cessation intervention in patients with schizophrenia and healthy smokers. The study included four parallel groups: schizophrenia patients receiving virtual reality intervention, schizophrenia patients receiving no intervention, healthy controls receiving virtual reality intervention, and healthy controls receiving no intervention. Participants were evaluated before and after the intervention period using measures of nicotine dependence, cigarette consumption, clinical symptoms, neuropsychological performance, quality of life, and social condition.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Balçova
      • Izmir, Balçova, Turkey (Türkiye), 35330
        • Dokuz Eylul University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Being between 18 and 60 years of age Being on a stable dose of the same antipsychotic medication for the previous 12 weeks Not having received electroconvulsive therapy (ECT) within the past 6 months Being able to read and write in Turkish Scoring at least 3 on the Fagerström Test for Nicotine Dependence Having no prior smoking cessation treatment or intervention history

Exclusion Criteria:

  • Diagnosis of any severe physical or neurological disorder affecting clinical functioning Presence of auditory or visual impairment Alcohol or substance use disorder/dependence Intellectual disability Suicidal risk or harmful/aggressive behavior Any pulmonary disease or severe respiratory condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Schizophrenia VR Intervention Group
Patients with schizophrenia who received Virtual Reality-based smoking cessation treatment for 10 weeks.
Behavioral: Schizophrenia VR Intervention Group
Participants received Virtual Reality-based smoking cessation treatment consisting of immersive virtual scenarios designed to reduce smoking behavior and support smoking cessation. The intervention was administered over 10 weeks through structured virtual reality sessions.
No Intervention: Schizophrenia Control Group
Patients with Schizophrenia who received no smoking cessation intervention during the 10-week study period.
Experimental: Healthy Control VR Intervention Group
Healthy control participants who received Virtual Reality-based smoking cessation treatment for 10 weeks.
Behavioral: Healthy Control VR Intervention Group
Participants received Virtual Reality-based smoking cessation treatment consisting of immersive virtual scenarios designed to reduce smoking behavior and support smoking cessation. The intervention was administered over 10 weeks through structured virtual reality sessions.
No Intervention: Healthy Control No-Intervention Group
Healthy control participants who received no smoking cessation intervention during the 10-week study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fagerstrom Test for Nicotine Dependence (FTND)
Time Frame: From enrollment to the end of treatment at 10 weeks.
The Fagerström Test for Nicotine Dependence, developed by Karl Fagerström in 1996 (Fagerström et al., 1996), was used to assess the level of nicotine dependence. The FTND is a self-report measure consisting of six items, with total scores ranging from 0 to 10; higher scores indicate greater nicotine dependence. In this study, the FTND was administered at baseline before the intervention and again at the post-treatment assessment conducted 10 weeks later.
From enrollment to the end of treatment at 10 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Köksal Alptekin, Professor, Dokuz Eylul University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2018

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

May 24, 2026

First Submitted That Met QC Criteria

May 24, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBTK-116S399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data may be shared upon reasonable request to the study investigators, provided that the proposed use is scientifically justified and complies with ethical and confidentiality requirements.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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