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临床试验/NCT03519451
NCT03519451进行中(未招募)不适用

Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment - A Pilot Study

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
1
主要终点
KickAsh group compliance with mood rating

研究概览

简要总结

This trial studies how well smartphone mobile applications work in enhancing smoking cessation treatment in current smokers. Smartphone mobile applications may help current smokers quit smoking.

详细描述

PRIMARY OBJECTIVES:

I. To test the acceptability and preliminary efficacy of a smartphone health application (app), Kick Ash, which will incorporate brief behavioral activation versus (vs.) a relaxation app, Breathe2Relax in a small randomized controlled trial of smokers with elevated depressive symptoms.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.

GROUP II: Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

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
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

入选标准

  • MD Anderson patient between the ages of 18 to 65
  • Current smoker (i.e., at least 1 cigarette or e-cigarette per day)
  • Smoking for at least one year
  • Willing to set a quit date in the next 30 days
  • Not engaged in smoking cessation treatment other than the MDACC Tobacco Treatment Program
  • Currently elevated depressive symptoms or a history of elevated depressive symptoms; (PHQ 2 = or > 1); current or past
  • English speaking and ability to read and comprehend English
  • Currently own an iOS mobile phone or tablet (iPhone; iPad) using iOS 9.0 or later and reports regular use (at least weekly) of at least 1 iOS app

排除标准

  • Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Collaborator
  • Subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study

研究组 & 干预措施

Group I (KickAsh smartphone mobile application)

Experimental

Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.

干预措施: Internet-Based Intervention (Other)

Group I (KickAsh smartphone mobile application)

Experimental

Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.

干预措施: Questionnaire Administration (Other)

Group II (Breathe2Relax smartphone mobile application)

Experimental

Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

干预措施: Internet-Based Intervention (Other)

Group II (Breathe2Relax smartphone mobile application)

Experimental

Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

干预措施: Questionnaire Administration (Other)

结局指标

主要结局

KickAsh group compliance with mood rating

时间窗: Up to 8 weeks from start of study

KickAsh group compliance with mood rating determined by questionnaires, phone calls, and interview.

Evidence of increased activity level in KickAsh and Breathe2Relax groups

时间窗: Up to 8 weeks from start of study

Increase in activity level determined by questionnaires, phone calls, and interview.

Evidence of greater smoking abstinence in KickAsh and Breathe2Relax groups

时间窗: Up to 8 weeks from start of study

Evidence of greater smoking abstinence determined by questionnaires, phone calls, and interview.

KickAsh group change in activity level

时间窗: Up to 8 weeks from start of study

KickAsh group change in activity level determined by questionnaires, phone calls, and interview.

KickAsh group user satisfaction

时间窗: Up to 8 weeks from start of study

KickAsh group user satisfaction determined by questionnaires, phone calls, and interview.

Evidence of improved mood in KickAsh and Breathe2Relax groups

时间窗: Up to 8 weeks from start of study

Evidence of improved mood determined by questionnaires, phone calls, and interview.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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