Schizophrenia DisorderNCT07618338
Virtual Reality-Based Smoking Cessation Treatment in Patients With Schizophrenia
A study testing Schizophrenia VR Intervention Group in people with Schizophrenia Disorder, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Disorder
- What is being tested?
- Schizophrenia VR Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Sep 2018to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University Faculty of Medicine
Izmir, Balçova, 35330
About this study
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.
Read the 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.
- Conditions
- Schizophrenia Disorder
- Being tested
- Schizophrenia VR Intervention Group, Healthy Control VR Intervention Group
- Keywords
- Schizophrenia, Virtual Reality, Smoking Cessation
- Medical subject headings
- Schizophrenia, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schizophrenia VR Intervention GroupBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia VR Intervention Group | Experimental | Patients with schizophrenia who received Virtual Reality-based smoking cessation treatment for 10 weeks. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start17 Sep 2018
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Emine Ilgın Hoşgelen, Dokuz Eylul University
- Investigators
- Köksal Alptekin, Professor, Principal investigator, Dokuz Eylul University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618338
- Sponsor's protocol ID
- TBTK-116S399
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41709911Santiago-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.
PubMed 39845432Peritogiannis 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.
PubMed 36553890
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-Based Smoking Cessation Treatment in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07618338
- Acronym / sponsor ID
- TBTK-116S399
- Conditions
- Schizophrenia Disorder
- Keywords
- Schizophrenia, Virtual Reality, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia VR Intervention Group | Experimental | Behavioral: Schizophrenia VR Intervention GroupPatients with schizophrenia who received Virtual Reality-based smoking cessation treatment for 10 weeks. |
| 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 | Behavioral: Healthy Control VR Intervention GroupHealthy control participants who received Virtual Reality-based smoking cessation treatment for 10 weeks. |
| Healthy Control No-Intervention Group | No intervention | –Healthy control participants who received no smoking cessation intervention during the 10-week study period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schizophrenia VR Intervention GroupParticipants 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. | Behavioural | Schizophrenia VR Intervention Group |
| Healthy Control VR Intervention GroupParticipants 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. | Behavioural | Healthy Control VR Intervention Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 41709911Bekkering 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.
- Background: PubMed 39845432Santiago-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.
- Background: PubMed 36553890Peritogiannis 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Köksal Alptekin, Professor principal investigator
Dokuz Eylul University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schizophrenia VR Intervention Group in people with Schizophrenia Disorder, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fagerstrom Test for Nicotine Dependence (FTND) (time frame: From enrollment to the end of treatment at 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07618338, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.