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临床试验/NCT02218281
NCT02218281已完成不适用

Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
146
试验地点
2
主要终点
Feasibility of study recruitment into the three interventions

研究概览

简要总结

The recent Surgeon General's Report calls for effective and readily available treatment approaches to help adolescent smokers interested in quitting. Schools are an ideal venue for connecting adolescent smokers with smoking cessation assistance. This study will adapt the Craving to Quit (C2Q) smartphone app, which integrates mindfulness training into a smoking cessation program, for teen smokers (C2Q-Teen). We will test how well this novel app helps teens stop smoking compared to another teen smoking cessation app that does not include mindfulness training, and to written cessation information alone. If effective, the C2Q-Teen would be relatively easy to disseminate widely and have tremendous public health significance

详细描述

The new Surgeon General's Report (SGR), Preventing Tobacco Use Among Youth and Young Adults, highlights the addictive nature of nicotine and emphasizes the need for effective and accessible cessation treatment for the more than 3.6 million youth who smoke. This proposal is in response to PA-13-078, Behavioral and Integrative Treatment Development Program (R34), which supports the development and testing of behavioral interventions targeting substance abuse, including studies focused on Intervention generation and refinement (Stage IA), and pilot or feasibility (Stage IB), and research designed to "increase implementability of interventions with creative use of technology". We have developed Craving to Quit (C2Q), a smartphone intervention for smoking cessation for adults that integrates mindfulness training (MT) into a smoking cessation curriculum. While MT has been shown to be efficacious for smoking cessation in adults, it has not been tested in adolescents. In addition, dissemination of MT is challenging due to the need for experienced MT therapists, high time demand, difficulties in scheduling sessions, and high costs of in-person treatment delivery. Mobile, smartphone technologies provide a promising medium for overcoming these barriers to dissemination. We propose to adapt and refine our existing Craving to Quit (C2Q) app for use by adolescent smokers (Stage IA), and to conduct feasibility and pilot testing (Stage IB) in preparation for an R01 application to definitively test efficacy and probe psychological mechanisms of change resulting from MT. In the pilot test, six public high schools will be randomly assigned to one of three conditions, two schools per condition: (1) C2Q-Teen app (smoking cessation delivered through a smartphone app via MT), (2) NCI's QuitSTART app designed for teen smokers (NCI-QS) (smoking cessation delivered through a smartphone app without MT), or (3) written smoking cessation materials only (MO). One hundred forty four adolescent smokers interested in quitting will be recruited (24/school, 48/condition). School nurses will introduce the three interventions in the school setting. Our first primary aim is to adapt the C2Q app for use by adolescent smokers (C2Q-Teen). Our second primary aim is to evaluate the feasibility and acceptability of the interventions to ensure adequacy of each intervention for a larger RCT designed specifically to compare efficacy rates. Secondary aims are to assess relative efficacy of the three interventions and independent contributions of smartphone intervention delivery and mindfulness in increasing cotinine-validated 7-day point prevalence abstinence at 3- and 6-month follow-up in order to adequately power a larger trial, and to determine the relationship between C2Q-Teen usage and abstinence. If eventually found to be effective, C2Q-Teen offers an innovative and potentially powerful intervention for supporting teens in their efforts to quit that would be relatively easy to disseminate widely and have tremendous public health significance, addressing the SGR's call for readily available treatment for adolescent smokers wanting to quit

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • enrolled in grade 9-12
  • smoked at least 5 cigarettes on average per day for the past 7 days
  • interested in quitting smoking in the next three weeks
  • have a smartphone on iPhone or Android platforms
  • English-speaking

排除标准

  • unable or unwilling to provide informed assent
  • diagnosis of a serious psychiatric illness during the past 5 years
  • developmental delay that would prevent study participation

结局指标

主要结局

Feasibility of study recruitment into the three interventions

时间窗: Baseline

We will assess the ability to recruit 144 adolescents into the trial at baseline.

Feasibility of retention of participants at 3-month follow-up

时间窗: 3-month follow-up

We will assess the ability to retain 80% of the 144 adolescents recruited at 3-month follow-up.

Feasibility of retention of participants at 6-month follow-up

时间窗: 6-month follow-up

We will assess the ability to retain 80% of the 144 adolescents recruited at 6-month follow-up.

Acceptability of the three interventions

时间窗: 3-month follow-up

Assess the percentage of participants in each condition that indicate high utilization and acceptability ratings (at least 80% hypothesized)

次要结局

  • C2Q-Teen program usage as a predictor of smoking abstinence(3- and 6-month follow-up)
  • Cotinine-validated 7-day point prevalence abstinence(3- and 6-months follow-up)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lori Pbert

Professor of Medicine

University of Massachusetts, Worcester

研究点 (2)

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