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Virtual Reality-Based Smoking Cessation Treatment in Patients With Schizophrenia

29. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Schizophrenia VR Intervention Group
Patients with schizophrenia who received Virtual Reality-based smoking cessation treatment for 10 weeks.
Adfærdsmæssigt: 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.
Ingen indgriben: Schizophrenia Control Group
Patients with Schizophrenia who received no smoking cessation intervention during the 10-week study period.
Eksperimentel: Healthy Control VR Intervention Group
Healthy control participants who received Virtual Reality-based smoking cessation treatment for 10 weeks.
Adfærdsmæssigt: 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.
Ingen indgriben: Healthy Control No-Intervention Group
Healthy control participants who received no smoking cessation intervention during the 10-week study period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fagerstrom Test for Nicotine Dependence (FTND)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dokuz Eylul University

Samarbejdspartnere

The Scientific and Technological Research Council of Turkey

Efterforskere

  • Ledende efterforsker: Köksal Alptekin, Professor, Dokuz Eylul University Faculty of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. september 2018

Primær færdiggørelse (Faktiske)

15. januar 2020

Studieafslutning (Faktiske)

15. januar 2020

Datoer for studieregistrering

Først indsendt

24. maj 2026

Først indsendt, der opfyldte QC-kriterier

24. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TBTK-116S399

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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