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- Ensaio Clínico NCT07618338
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Balçova
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Izmir, Balçova, Turquia (Türkiye), 35330
- Dokuz Eylul University Faculty of Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Schizophrenia VR Intervention Group
Patients with schizophrenia who received Virtual Reality-based smoking cessation treatment for 10 weeks.
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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.
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Sem intervenção: Schizophrenia Control Group
Patients with Schizophrenia who received no smoking cessation intervention during the 10-week study period.
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Experimental: Healthy Control VR Intervention Group
Healthy control participants who received Virtual Reality-based smoking cessation treatment for 10 weeks.
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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.
|
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Sem intervenção: Healthy Control No-Intervention Group
Healthy control participants who received no smoking cessation intervention during the 10-week study period.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fagerstrom Test for Nicotine Dependence (FTND)
Prazo: From enrollment to the end of treatment at 10 weeks.
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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.
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From enrollment to the end of treatment at 10 weeks.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Köksal Alptekin, Professor, Dokuz Eylul University Faculty of Medicine
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TBTK-116S399
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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