NCT07618338

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

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

September 17, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

May 24, 2026

Last Update Submit

May 29, 2026

Conditions

Schizophrenia Disorder

Keywords

SchizophreniaVirtual RealitySmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Fagerstrom Test for Nicotine Dependence (FTND)

    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.

Study Arms (4)

Schizophrenia VR Intervention Group

EXPERIMENTAL

Patients with schizophrenia who received Virtual Reality-based smoking cessation treatment for 10 weeks.

Behavioral: Schizophrenia VR Intervention Group

Schizophrenia Control Group

NO INTERVENTION

Patients with Schizophrenia who received no smoking cessation intervention during the 10-week study period.

Healthy Control VR Intervention Group

EXPERIMENTAL

Healthy control participants who received Virtual Reality-based smoking cessation treatment for 10 weeks.

Behavioral: Healthy Control VR Intervention Group

Healthy Control No-Intervention Group

NO INTERVENTION

Healthy control participants who received no smoking cessation intervention during the 10-week study period.

Interventions

Schizophrenia VR Intervention GroupBEHAVIORAL

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.

Schizophrenia VR Intervention Group
Healthy Control VR Intervention GroupBEHAVIORAL

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.

Healthy Control VR Intervention Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 18 and 60 years of age
  • Being on a stable dose of the same antipsychotic medication for the previous 12 weeks
  • Being able to read and write in Turkish
  • Scoring at least 3 on the Fagerström Test for Nicotine Dependence

You may not qualify if:

  • Diagnosis of any severe physical or neurological disorder affecting clinical functioning
  • Presence of auditory or visual impairment
  • Alcohol or substance use disorder/dependence
  • Having Intellectual disability
  • Suicidal risk or harmful/aggressive behavior
  • Any pulmonary disease or severe respiratory condition
  • Having prior smoking cessation treatment or intervention history
  • Having received electroconvulsive therapy (ECT) within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Faculty of Medicine

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related Publications (3)

  • Bekkering GE, Detraux J, Lopez-Lopez JA, De Hert M, Evins AE, Vanhove AC, Cloetens H, Algarni AM, Vandendriessche T, Agarwal A, Agoritsas T, Aertgeerts B, Delvaux N, Vermandere M. Smoking cessation for people with severe mental illness: systematic review and network meta-analysis. BMJ Med. 2026 Feb 12;5(1):e002190. doi: 10.1136/bmjmed-2025-002190. eCollection 2026.

    PMID: 41709911BACKGROUND

  • Santiago-Torres M, Mull KE, Sullivan BM, Prochaska JJ, Zvolensky MJ, Bricker JB. Can an Acceptance and Commitment Therapy-Based Smartphone App Help Individuals with Mental Health Disorders Quit Smoking? Depress Anxiety. 2024;2024:1055801. doi: 10.1155/2024/1055801. Epub 2024 Jun 21.

    PMID: 39845432BACKGROUND

  • Peritogiannis V, Ninou A, Samakouri M. Mortality in Schizophrenia-Spectrum Disorders: Recent Advances in Understanding and Management. Healthcare (Basel). 2022 Nov 25;10(12):2366. doi: 10.3390/healthcare10122366.

    PMID: 36553890BACKGROUND

MeSH Terms

Conditions

SchizophreniaSmoking Cessation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersHealth BehaviorBehavior

Study Officials

  • Köksal Alptekin, Professor

    Dokuz Eylul University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two intervention groups included Schizophrenia patients and healthy controls who received Virtual Reality-based smoking cessation treatment for 10 weeks. Two control groups included schizophrenia patients and healthy controls who received no smoking cessation intervention during the same period. All groups were assessed at baseline and reassessed after 10 weeks to compare changes in smoking behavior, clinical symptoms, and cognitive outcomes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Neuroscience

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 1, 2026

Study Start

September 17, 2018

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

TU(1)