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临床试验/NCT04461288
NCT04461288已完成不适用

Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2020年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
1
主要终点
Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months

研究概览

简要总结

This research study will evaluate the preliminary efficacy of Pride Posts Plus, a social media-based smoking cessation treatment. A pilot randomized trial (N=120) will compare Pride Posts Plus, which includes a gamification element, to Pride Posts (without gamification) and to a usual care treatment. Participants will be adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be treatment engagement, a quit attempt (y/n), and thoughts about tobacco abstinence at 3 and 6 mos.

详细描述

Participants (N=136) will be randomized to one of three conditions: (1) Pride Posts, a Facebook-delivered smoking cessation intervention (including daily posts, and weekly live group sessions, tailored to sexual and gender minority (SGM) adults; (2) Pride Posts Plus, the Facebook-delivered smoking cessation intervention plus a gamification element, or (2) a usual care condition which includes referral to smokefree.gov, a federally-developed web-based intervention which includes similar digital treatment elements. All participants will have access to up to six months of nicotine replacement therapy (NRT).

Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to provide biochemical verification of smoking status using a portable carbon monoxide measurement tool. All intervention and assessment procedures will be conducted digitally.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Daily smoker
  • •Self-identify as sexual and/or gender minority
  • •Interested in quitting in next 6 months
  • •6 months of Facebook experience
  • •English-speaking

排除标准

  • •Contraindications to nicotine replacement therapy

研究组 & 干预措施

Pride Posts

Experimental

This six month intervention will be conducted on the Facebook platform. Participants will receive regular social media posts tailored to the sexual and gender minority communities (LGBTQ+). Weekly live sessions with a tobacco expert will be available. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.

干预措施: Social media-based education, counseling, and support (Behavioral)

Pride Posts

Experimental

This six month intervention will be conducted on the Facebook platform. Participants will receive regular social media posts tailored to the sexual and gender minority communities (LGBTQ+). Weekly live sessions with a tobacco expert will be available. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.

干预措施: Nicotine replacement therapies (NRT) (Other)

Pride Posts Plus

Experimental

This six month intervention will include all elements of the Pride Posts arm. In addition, the intervention will include gamification, gaming elements designed to encourage participation in the program and behavior change. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.

干预措施: Social media-based education, counseling, and support (Behavioral)

Pride Posts Plus

Experimental

This six month intervention will include all elements of the Pride Posts arm. In addition, the intervention will include gamification, gaming elements designed to encourage participation in the program and behavior change. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.

干预措施: Nicotine replacement therapies (NRT) (Other)

Pride Posts Plus

Experimental

This six month intervention will include all elements of the Pride Posts arm. In addition, the intervention will include gamification, gaming elements designed to encourage participation in the program and behavior change. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.

干预措施: Gamification (Other)

Usual Care Condition

Active Comparator

Participants in this arm will be provided with a referral to smokefree.gov, a federally-funded website which provides support and digital-based interventions to assist in smoking cessation activities. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.

干预措施: Nicotine replacement therapies (NRT) (Other)

结局指标

主要结局

Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months

时间窗: 3 months

Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 3 month assessment.

Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months

时间窗: 6 months

Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 6 month assessment.

次要结局

  • Frequency of social media posts(3 to 6 months)
  • Frequency of participation in live group sessions(3 to 6 months)
  • Responses to the Thoughts About Abstinence Questionnaire Over Time(3 to 6 months)
  • Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment(3 to 6 months)
  • Duration of Active Participation(3 to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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