Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of Participants Who Self-report Prolonged Abstinence
研究概览
简要总结
This study is designed to evaluate if a treatment the investigators call iCOMMIT is effective at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation treatment that combines mobile technology with behavioral strategies, counseling, and medications.
详细描述
The purpose of this 2-arm randomized controlled trial (RCT) is to evaluate the efficacy of Multi-Component Mobile-enhanced Treatment for Smoking Cessation (iCOMMIT) in helping individuals with schizophrenia or other psychotic disorders stop smoking. Eligible participants will be randomized to receive iCOMMIT, which includes smoking cessation counseling, pharmacotherapy, and mobile technology components, or a control intervention that includes smoking cessation counseling and pharmacotherapy, but no mobile technology components. The control condition represents an intensive standard of care and helps control for monitoring, counselor, time, and attention effects.
The primary outcome for the study will be self-reported and bio-verified prolonged smoking abstinence at the 6-month follow-up. Self-reported prolonged abstinence will be verified by saliva cotinine assay. Secondary outcomes will include 7- and 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 or 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently smoke at least ten cigarettes a day
- •Have been smoking for at least one year
- •Meet criteria for schizophrenia, schizoaffective disorder, or another psychotic disorder based on structured clinical interview
- •Can speak and write fluent conversational English
- •Are between 18 and 70 years of age
- •Are willing to make a smoking cessation attempt
- •Score 26 or higher on the Montreal Cognitive Assessment
排除标准
- •Have a history of myocardial infarction in the past 6 months
- •Have a contraindication to NRT with no medical clearance from the primary care provider or study physician
- •Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco
- •Are pregnant
- •Meet criteria for a current manic episode based on structured clinical interview
- •Are currently enrolled in another smoking cessation trial
- •Are currently imprisoned or in psychiatric hospitalization
研究组 & 干预措施
iCOMMIT
The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
干预措施: Nicotine replacement therapy (Drug)
iCOMMIT
The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
干预措施: Bupropion (Drug)
iCOMMIT
The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
干预措施: cognitive-behavioral smoking cessation counseling (Behavioral)
iCOMMIT
The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
干预措施: Mobile Contingency Management (Behavioral)
iCOMMIT
The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
干预措施: Stay Quit Coach (Behavioral)
iCOMMIT
The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
干预措施: SMS text messaging (Behavioral)
Control Group
The components of the intervention include 1) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; and 2) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation.
干预措施: Nicotine replacement therapy (Drug)
Control Group
The components of the intervention include 1) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; and 2) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation.
干预措施: Bupropion (Drug)
Control Group
The components of the intervention include 1) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; and 2) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation.
干预措施: cognitive-behavioral smoking cessation counseling (Behavioral)
结局指标
主要结局
Number of Participants Who Self-report Prolonged Abstinence
时间窗: 6 month follow-up
Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials.
Number of Participants Whose Prolonged Abstinence is Bio-verified
时间窗: 6 month follow-up
Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence at each follow-up.
次要结局
- Number of Participants Who Report 30 Day Point Prevalence Abstinence(6 months post-quit attempt (Session 6))
- Number of Participants Who Report 7 Day Point Prevalence Abstinence(6 months post-quit attempt (Session 6))