Virtual Reality-Based Smoking Cessation Treatment in Patients With Schizophrenia
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Balçova
-
Izmir, Balçova, Turquía (Türkiye), 35330
- Dokuz Eylul University Faculty of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
- Being able to read and write in Turkish
- Scoring at least 3 on the Fagerström Test for Nicotine Dependence
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
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Schizophrenia VR Intervention Group
Patients with schizophrenia who received Virtual Reality-based smoking cessation treatment for 10 weeks.
|
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.
|
|
Sin intervención: 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.
|
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.
|
|
Sin intervención: Healthy Control No-Intervention Group
Healthy control participants who received no smoking cessation intervention during the 10-week study period.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fagerstrom Test for Nicotine Dependence (FTND)
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Köksal Alptekin, Professor, Dokuz Eylul University Faculty of Medicine
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TBTK-116S399
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Schizophrenia VR Intervention Group
-
Nuh Naci Yazgan UniversityAún no reclutandoSer diagnosticado con infertilidad primaria | Haber tenido una transferencia de embriones por primera vezPavo
-
Norther Private Collage of NursingTerminadoIntervenciones de enfermeríaArabia Saudita, Egipto