The Effect of Cigarette Holders, Plastic Menthol Cigarettes, and Cognitive Behavioral Therapy for Smoking Reduction Among Schizophrenia Inpatients: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Subjective Quality of Life:
研究概览
简要总结
This study aims:
1. to assess the effect of smoking reduction programs (behavior therapy alone or behavior therapy with cigarette holders; "Flowers Menthol" plastic cigarettes with menthol) on cigarette smoking habits in an antipsychotic treated schizophrenia population.
详细描述
Smoking is a leading preventable cause of death in the western world. The highest incidence of smoking is among psychiatric inpatients. The issue of smoking among psychiatric patients needs to be addressed, since this population already suffers from physical comorbidity and reduced life expectancy (Brown et al., 2000), which increase with smoking, considering the additional risk factors for cardiovascular diseases: obesity, high cholesterol, diabetes. In addition the increased risk factors associated with second generation antipsychotic treatment need to be considered. Significant financial expenditures for the purchase of cigarettes, from an already extremely limited budget (Steinberg et al., 2004) should be taken into account. Psychiatric patients who smoke spend up to 30% of their welfare payments on cigarettes.
A survey performed in our mental health center revealed that over 30% of the patients who smoke are interested in specific treatment to reduce/stop smoking (Melamed et al., unpublished). Our survey found that The expressed desire of the patients to quit smoking and the known dangers of smoking, especially in this population, reflect the importance of integrating smoking reduction/cessation programs into the treatment regimens of psychiatric inpatients.
Treatment options to promote smoking cessation include hypnosis (Spiegel et la., 1993; Weizman et al., 2004), behavior therapy (Addington et al., 1998), group therapy (Addington, 1998), nicotine replacement therapies (NRT) (Fant et al., 2000), and pharmacotherapy such as bupropion (George et al., 2002).
Since it is recommended that many smoking cessation treatment options such as NRT (nicotine transdermal patches or nicotine polacrilex gum, nasal spray, cigarette filters and nicotine inhalers) should not be used together with actual nicotine intake we decided to gradually introduce the issue of smoking reduction/cessation to the inpatient population, by initially introducing a program for smoking reduction.
Smoking reduction options include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 male or female.
- •DSM -IV criteria for chronic schizophrenia or schizoaffective disorder.
- •Ability and willingness to sign informed consent for participation in the study.
- •Patients' expressed interest in participating in a smoking-reduction program
- •Smoking a minimum of 20 cigarettes daily, for 6 months prior to the study period, as per patient report.
- •Patients treated with antipsychotic agents.
排除标准
- •Significant physical illness.
- •Evidence of organic brain damage , mental retardation , alcohol or drug abuse.
- •Pregnant or nursing female patients.
结局指标
主要结局
Subjective Quality of Life:
时间窗: 6 weeks
Assessment of smoking dependence:
时间窗: 6 weeks
The Fagerstrom Tolerance Questionnaire for Nicotine Dependence (FTND)
时间窗: 6 weeks
Weekly table for self-report of the number of cigarettes smoked will be filled out by participants with the help of the "smoking supervisors".
时间窗: 6 weeks
Quality of life enjoyment and satisfaction questionnaire -abbreviated version
时间窗: 6 weeks
次要结局
- Clinical Rating Scales:(6 weeks)
- Positive and Negative Syndrome Scale (PANSS)(6 weeks)
- Clinical Global Impression (CGI) scale for psychosis(6 weeks)
- Hamilton Rating Scale for Depression (HAM-D)(6 weeks)
- Simpson Angus Scale for extrapyramidal side effects (SAS)(6 weeks)