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临床试验/NCT04887558
NCT04887558进行中(未招募)2 期

Smartphone-Based Smoking Cessation and Mental Health Intervention

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年12月14日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
64
试验地点
2
主要终点
Biochemically-Verified Smoking Cessation

研究概览

简要总结

Adults with serious mental illness (SMI) represent 5% of the United States population, yet account for 30% of all cigarettes smoked and are 2 to 3 times more likely to be dependent on nicotine compared with the general population. There are also significant disparities in quitting: 24% of lifetime smokers with SMI report not smoking within the past year compared with 52% of lifetime smokers without SMI. Two barriers partly explain the large disparity in smoking cessation rates between adults with and without SMI. First, there is a lack of high-quality, evidence-based interventions for smoking cessation in populations with SMI, which may be because adults with SMI are often excluded from clinical trials, despite evidence indicating that SMI is highly comorbid with smoking. Second, clinicians and staff within mental health settings generally do not have the resources or appropriate training to provide smoking cessation treatments to patients with SMI. Smartphone-based mobile health applications for smoking cessation could significantly improve cessation rates for adults with SMI. However, smoking cessation apps are underutilized by smokers with SMI partly because the apps are not designed for their unique needs. This study aims to conduct a pilot randomized controlled trial to evaluate the feasibility of an innovative, evidence-based smoking cessation app tailored for smokers with SMI. Seventy-five treatment-seeking smokers with SMI who will be referred from the Oklahoma Department of Mental Health and Substance Abuse Services (25 per group), a publicly funded outpatient psychiatry treatment program, will be randomly assigned to receive either (1) QuitGuide, a free smoking cessation app developed by the National Cancer Institute, (2) a smoking cessation app that tracks and automatically intervenes upon psychological distress during a quit attempt and delivers real-time intervention messages tailored to the current level of lapse risk and current lapse triggers (Smart-T Mental Health; STMH), or (3) the STMH app with additional messaging focused on increasing adherence to nicotine replacement medications (STMH+). All study conditions will be followed for 5 weeks (1-week pre-cessation and 4 weeks post-cessation), receive nicotine replacement therapy, and complete smartphone-based survey assessments using ecological momentary assessment procedures.

详细描述

SPECIFIC AIMS

Cigarette smoking is the leading preventable cause of morbidity and mortality in the United States. Smokers with serious mental illness (SMI; e.g., schizophrenia, bipolar disorder, major depressive disorder, anxiety disorders) have an increased risk of dying from cancer, lung disease, and cardiovascular disease and account for more than 200,000 of the 520,000 tobacco-related deaths each year. Many studies have shown that smoking rates are 2-5 times higher in adults with SMI compared with adults with no mental illness. People with SMI smoke more frequently and heavily than the general population, and they often lack access to cessation services. Furthermore, smokers with SMI are more dependent on nicotine and are less likely to quit than those without SMI. Thus, smoking and smoking cessation in this population are critical public health concerns that warrant further study.

Although there is substantial evidence for the effectiveness of multiple smoking cessation treatments for the general population of smokers, these interventions tend to be less effective or not effective at all when provided to smokers with SMI. Thus, while smoking rates among those without a history of SMI has radically declined over the past 5 decades, smoking prevalence among those with SMI has remained alarmingly high over this same time period. While several studies have identified some reasons for disparities in smoking cessation treatment effectiveness in adults with SMI, understanding of the complex causes of this known and growing disparity remains limited. A more granular examination of the cessation, lapse, and relapse process among adult smokers with SMI is needed: 1) to improve understanding of smoking cessation in this vulnerable and understudied population, and 2) to inform the development of more effective interventions for this underserved population. Smartphone-based Ecological Momentary Assessments (EMA) have been used to identify antecedents to smoking lapse in various populations. Just-in-Time Adaptive Interventions (JITAI) that provide tailored treatment content for adults with SMI in moments when it is needed most may offer cost-effective, easily accessible, highly tailored interventions in free-living settings. To date, four smartphone-based smoking cessation JITAIs have been created, and pilot tested in SMI samples. Yet, few JITAI for SMI populations have been investigated regarding their acceptability, feasibility, and usefulness.

The long-term goal of this research is to increase smoking cessation rates of smokers with SMI using a smartphone-based mobile health application. The primary objective of this study, which is the next step towards achieving this long-term objective, is to conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility of an innovative smoking cessation app that has been tailored for smokers with SMI. Seventy-five treatment-seeking smokers with SMI, referred from the Oklahoma Department of Mental Health and Substance Abuse Services (ODMH),49 will be randomly assigned to receive either (1) QuitGuide,50 a free smoking cessation app developed by the National Cancer Institute (NCI), (2) a smoking cessation app that tracks and automatically intervenes upon psychological distress in real-time during a quit attempt and delivers real-time intervention messages tailored to the current level of lapse risk and current lapse triggers (i.e., Smart-T Mental Health; STMH), or (3) STMH with additional nicotine replacement therapy adherence messaging (STMH+). Participants in both study conditions will be followed for 5 weeks (1-week pre-cessation and 4 weeks post-cessation), receive nicotine replacement therapy (NRT), and complete smartphone-based ecological momentary assessments (EMA). The primary objective of this study will be attained by pursuing the following specific aims.

Determine the feasibility, ease of use, and perceived utility of a smoking cessation app designed for adults with SMI.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • valid residential address to mail study materials
  • earn a score ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) indicating > 6th grade English literacy level (required to complete EMAs; at least 88% of all individuals screened for our EMA studies have met this inclusion criterion)
  • willingness to quit smoking 7 days after the randomization phone call
  • currently smoke ≥ 10 cigarettes per day
  • willing and medically eligible to use combination NRT
  • agree to complete daily EMAs and thrice-weekly CO tests on a study provided or personal smartphone
  • agree to complete the 5-week post-quit follow-up assessment (i.e., smartphone based quantitative survey and qualitative interview via phone call).

排除标准

  • Individuals who score ≥ 8 on the Cognitive Impairment Test, which indicates severe cognitive impairment,
  • Pregnant or intend to become pregnant during the study period.

研究组 & 干预措施

NCI QuitGuide and NRT

Active Comparator

The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free NRT.

干预措施: QuitGuide + NRT (Combination Product)

Smart-T Mental Health and NRT

Experimental

Smart-T Mental Health provides smoking cessation and mental health content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive NRT.

干预措施: Smart-T Mental Health and NRT (Combination Product)

Smart-T Mental Health+ and NRT

Experimental

Smart-T Mental Health provides smoking cessation and mental health content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. During the pre-quit and post-quit period, the app will also send messages that encourage the use of the nicotine patch and lozenges according to recommended practices. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free NRT.

干预措施: Smart-T Mental Health+ and NRT (Combination Product)

结局指标

主要结局

Biochemically-Verified Smoking Cessation

时间窗: 4 weeks

Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 7 ppm

次要结局

  • Change in anxiety(4 weeks)
  • Change in smoking urge(4 weeks)
  • Change in stress(4 weeks)
  • Change in cigarette availability(4 weeks)
  • Change in cessation motivation(4 weeks)
  • Change in depression(4 weeks)
  • Change in nicotine patch use(4 weeks)
  • Change in lozenge use(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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