- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Balçova
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Izmir, Balçova, 터키 (Türkiye), 35330
- Dokuz Eylul University Faculty of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: Schizophrenia Control Group
Patients with Schizophrenia who received no smoking cessation intervention during the 10-week study period.
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실험적: 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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간섭 없음: Healthy Control No-Intervention Group
Healthy control participants who received no smoking cessation intervention during the 10-week study period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fagerstrom Test for Nicotine Dependence (FTND)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Köksal Alptekin, Professor, Dokuz Eylul University Faculty of Medicine
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- TBTK-116S399
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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