Pilot Testing a Digital Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Smoking abstinence
研究概览
简要总结
All patients with serious mental illness are abstinent while in the hospital for a psychiatric admission yet almost all return to smoking after discharge. The investigators propose to test a digital intervention adapted to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting. Such an intervention could bridge the inpatient to outpatient gap in cessation services and will help people remain abstinent following hospital discharge.
详细描述
Persons with serious mental illness (SMI) die on average 10-15 years earlier than those in the general population. Smoking is the strongest risk factor for their elevated mortality. Helping SMI smokers to quit is an urgent and unmet need. The hospital is an optimal setting to provide smoking cessation services. Hospital admissions for SMI are common with more than 1.2 million inpatient stays for schizophrenia and mood disorders per year in the US. Hospitalized patients experience required abstinence, are available for counseling, and can try cessation medications in a supportive setting. The challenge is how to engage SMI patients in cessation services post-discharge. An easy-to-access digital intervention is a scalable and sustainable way to bridge the inpatient-to-outpatient gap and to promote sustained abstinence. Digital interventions can deliver all elements of cessation treatment and yield quit rates comparable to face to face and telephonic interventions. SMI patients use and benefit from technology-based interventions but currently there is no digital smoking cessation program addressing their needs. In this study, the investigators tested a digital intervention adapted to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting. The digital intervention, BecomeAnEX (EX), developed and run by Truth Initiative for over 10 years, includes real-time one on one coaching via live chat, nicotine replacement therapy decision support and delivery, personalized quit plans, a large online social network for peer support, a robust and fully integrated text message program, and tailored email messaging. SMI smokers recruited during psychiatric hospitalization will be randomized to usual care or to an adapted version of EX (EX-SMI) and followed for 3 months after the hospital stay. The investigators will compare the feasibility/acceptability of EX-SMI, measure intervention impact on target mechanisms, and obtain initial estimates of efficacy on 7-day point prevalence abstinence. Such an intervention could bridge the inpatient to outpatient gap in cessation services and will help people remain abstinent following hospital discharge.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or greater
- •Diagnosis of serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, or major depression)
- •Current smoker [prior to admission, smoked at least one cigarette or small cigar per day in the past month (unless restricted, e.g. due to ER/hospital visit) and smoked at least 100 cigarettes lifetime]
- •Interested in remaining quit after hospital discharge or quitting within the following 30 days
- •Expected Internet use at least 3 times/week post-discharge and ownership of mobile device with text messaging plan post-discharge.
- •Discharge destination within 1-hour of SPH given that Aim 3 involves biochemical verification (carbon monoxide testing).
- •Reading competence as demonstrated by a score of >= 37 on the Word Reading subtest of the Wide Range Achievement Test - 4th Edition (WRAT-4)168 to ensure the ability to engage in the intervention.
排除标准
- •Intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.
- •Homeless prior to admission or anticipated to be homeless at discharge.
- •Discharge to a residential setting where smoking is prohibited.
- •Medical condition for which the use of nicotine replacement therapy (NRT) is contraindicated including pregnant, planning to become pregnant, or breastfeeding; within 4 weeks post myocardial infarction; severe arrhythmia, severe angina pectoris; peptic ulcer; severe renal failure; poorly controlled insulin-dependent diabetes; severely uncontrolled hypertension; peripheral vascular disease.
研究组 & 干预措施
BecomeAnEX
Participants will have three individual meetings with a research staff person while they are in the hospital. At these meetings participants will answer questions about their smoking and interest in quitting, learn about BecomeAnEx, and register with the BecomeAnEx program so that they can use it when you leave the hospital. Participants will be given two weeks of nicotine replacement therapy when they leave the hospital. Participants will be asked to use BecomeAnEx as much as they want when they leave the hospital.
干预措施: BecomeAnEX (Behavioral)
BecomeAnEX
Participants will have three individual meetings with a research staff person while they are in the hospital. At these meetings participants will answer questions about their smoking and interest in quitting, learn about BecomeAnEx, and register with the BecomeAnEx program so that they can use it when you leave the hospital. Participants will be given two weeks of nicotine replacement therapy when they leave the hospital. Participants will be asked to use BecomeAnEx as much as they want when they leave the hospital.
干预措施: Usual Care (Behavioral)
Usual Care
Brief individual counseling, NRT during the hospital stay and a prescription for NRT at discharge (consistent with standard hospital procedures), and referral to the MD quitline.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Smoking abstinence
时间窗: 1 month
Self-report 7-day point prevalence abstinence
Motivation to remain abstinent
时间窗: 1 month
Abstinence-Related Motivational Engagement Scale
Craving
时间窗: 1 month
Craving was assessed with 11 items from the Tobacco Cravings Questionnaire (TCQ). Possible scores range from 11-77, with higher scores indicating greater tobacco craving.
Self-efficacy
时间窗: 1 month
The 9-item Abstinence Self-Efficacy Questionnaire (ASEQ) measured confidence to resist smoking across situations and emotional states. Possible scores range from 9-45, with higher scores indicating greater abstinence self-efficacy.
Smoking Abstinence
时间窗: 1 month
Self-report 7-day point prevalence abstinence
Abstinence-Related Motivational
时间窗: 1 month
The 16-item Abstinence-Related Motivational Engagement (ARME) assessed motivation to maintain smoking abstinence. Possible scores range from 16-112, with higher scores indicating greater abstinence-related motivation.
次要结局
未报告次要终点
研究者
Melanie E Bennett
Professor
University of Maryland, Baltimore