Approach Bias Retraining to Augment Long-Term Smoking Cessation Among a Diverse Sample
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- 7-day Biochemically Verified Point Prevalence Abstinence (PPA)
研究概览
简要总结
The present investigation aims to assess the efficacy of an innovative and novel smoking cessation intervention that integrates approach bias retraining (ABR) and standard smoking cessation treatment (ST). Participants will be randomized to either: (1) standard smoking cessation treatment and approach bias retraining (ST+ABR); (2) ST+Sham; or (3) ST-only.
详细描述
The study employs a randomized controlled design to follow 300 individuals who smoke cigarettes as they engage in a smoking quit attempt following standard smoking cessation treatment (ST). Participants will be randomized to one of three conditions: (1) ST+ABR; (2) ST+Sham; or (3) ST-only. Participants will complete a self-screener, baseline appointment, 7 weeks of smoking cessation treatment, combined with approach bias retraining (if applicable) in the laboratory (with the quit day scheduled for the 6th session), 2x daily ecological momentary assessments (EMAs) for 4-weeks following their quit day, and 1-, 3-, and 6-month follow-ups in the laboratory.
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
- Triple (Participant, Care Provider, 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
- •At least 18 years of age
- •Ability to speak English fluently
- •Ability to read English fluently
- •Ability to write in English fluently
- •Biochemical verification of self-reported smoking status following minimum study specified smoking rate endorsement
- •Motivated to quit smoking
- •Willing to attend in-person visits
- •Provide written informed consent, accepting study inclusion criteria and the randomized group assignment
- •English literacy of 7th grade or higher, as indicated by a score of 4 or greater on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)
排除标准
- •Having used an e-cigarette in the past 3 months
- •Having initiated any mental health therapy or pharmacotherapy within the past 3 months
- •Being currently in therapy for substance abuse (including nicotine dependence)
- •Being currently enrolled in any other studies at the RESTORE lab to help quit smoking
- •Currently using any NRT or psychotherapy products for nicotine cessation
- •Currently using Bupropion as a smoking cessation aid and antidepressant
- •Currently pregnant or planning to become pregnant
- •Having high blood pressure that is not under control
- •Having a heart attack within the past 2 weeks
- •Having Visual impairments
- •Hand-motoric impairments
- •Currently suicidal or high suicide risk or current or past psychotic disorders of any type, bipolar disorder, schizophrenia or schizoaffective disorder, anorexia, bulimia assessed using the Mini Neuropsychiatric Interview
- •Cognitive impairment, verified via a score of ≥8 on the Six-Item Cognitive Impairment Test (6-CIT)
研究组 & 干预措施
ST+ABR
ST+ABR is the combination of standard treatment (cognitive behavioral therapy [CBT]+ nicotine replacement therapy [NRT]) for smoking cessation based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use And Dependence and computerized Approach Bias Retraining (ABR) for smoking cessation.
干预措施: ST+ABR (Behavioral)
ST+Sham
ST+Sham is the combination of standard treatment (CBT+NRT) for smoking cessation based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use And Dependence and computerized Sham (Control) training.
干预措施: ST+Sham (Behavioral)
ST Only
ST Only will consist of standard treatment (CBT+NRT) for smoking cessation, based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use And Dependence.
干预措施: ST Only (Behavioral)
结局指标
主要结局
7-day Biochemically Verified Point Prevalence Abstinence (PPA)
时间窗: 1-week, 2-week, 3-week post-quit, and 1-, 3-, and 6-month follow-ups
PPA will be defined as no cigarette smoking within the past 7 days of assessments and will be biochemically verified via assessment of expired carbon monoxide.
Prolonged Abstinence (PA)
时间窗: 3-week post-quit, 1-, 3-, and 6-month follow-ups
Participants will self report their abstinence by reporting whether or not they have smoked since their quit date following a 2-week grace period.
7-day Biochemically Verified Point Prevalence Abstinence (PPA)
时间窗: [Time Frame: Baseline appointment through the 6-month follow-up, inclusive of every assessment (daily 2x EMAs for 4 weeks; 1-, 3-, and 6-month follow-ups)]
PPA will be defined as no cigarette smoking within the past 7 days of assessments, and will be biochemically verified via assessment of expired carbon monoxide (\<= 4ppm).
Prolonged Abstinence (PA)
时间窗: [Time Frame: Baseline appointment through the 6-month follow-up, inclusive of every assessment]
Participants will self report their abstinence by reporting whether or not they have smoked since their quit date.
次要结局
未报告次要终点
研究者
Lorra Garey
Research Associate Professor
University of Houston