Smartphone-Delivered Attentional Bias Modification Training for Quitting Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Smoking Stroop Task
研究概览
简要总结
This randomized clinical trial studies how well a smartphone-delivered attentional bias modification training works in helping patients quit smoking. Smartphone-delivered attentional bias modification training may help patients quit smoking by reducing the attentional bias (the tendency of one's perception to be affected by their recurring thoughts) towards smoking cues that developed over time as a result of conditioning processes through which smoking cues become important.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of smartphone-delivered, in-home attentional bias modification (ABM) to reduce attentional bias (AB) to smoking cues and to reduce smoking behavior in the short- and long-term.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
ARM II: Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 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
- Treatment
- 盲法
- Single (Participant)
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
- 否
入选标准
- •Smoke an average of 5 or more cigarettes or little cigars per day (CPD) prior to telephone screen
- •Produce an expired carbon monoxide (CO) level greater than or equal to 6 parts per million (ppm) or a NicAlert reading of > 2
- •Have a working telephone
- •Interested in quitting smoking in the next 30 days
- •Fluency in spoken and written English
- •Must sign the picture consent form
排除标准
- •Taking psychotropic, anticonvulsive, or narcotic medication
- •Meet criteria for a current major depressive episode or suicidality
- •Have a history of neurological illness or closed head injury
- •Report uncorrected vision problems
- •Involved in current smoking cessation activity
- •Testing positive on a urine drug screen for drugs of abuse/potential abuse
- •Women who are pregnant or breastfeeding
- •Considered by the investigator to be an unsuitable or unstable candidate (e.g., due to cognitive impairment)
- •Shares the same address as a currently enrolled participant
- •Unwilling to alter or remove hairstyle, hair extensions, or wig during the clinic visits to allow for correct electroencephalography (EEG) sensor placement
- •Reports diagnosis of seizure disorder
- •Unwilling to use nicotine replacement therapy (NRT) patches
研究组 & 干预措施
Arm I (ABM training)
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
干预措施: Computer-Assisted Smoking Cessation Intervention (Behavioral)
Arm I (ABM training)
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (ABM training)
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
干预措施: Nicotine Patch (Drug)
Arm I (ABM training)
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
干预措施: Questionnaire Administration (Other)
Arm II (sham training)
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (sham training)
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
干预措施: Nicotine Patch (Drug)
Arm II (sham training)
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
干预措施: Questionnaire Administration (Other)
Arm II (sham training)
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
干预措施: Sham Intervention (Other)
结局指标
主要结局
Smoking Stroop Task
时间窗: Up to 8 weeks post-training
The Stroop task will consist of three blocks, with a 5-s rest period between blocks: (a) practice (40 trials), (b) neutral words (80 trials), and (c) smoking words (80 trials). The score will be calculated by taking the mean RT difference between the smoking and neutral words on trials with correct responses within the response window.
Modified Dot-probe Task
时间窗: Up to 8 weeks post-training
Modified dot-probe task evaluated by using 2 (group: ABM vs. sham) X 3 (session: baseline, 1-day post-training, and 8-weeks post-training) linear mixed model using RT difference scores (neutral-cigarette) as the dependent measures and subject as the random effect.
次要结局
- Fagerström Test for Nicotine Dependence (FTND)(Up to 8 weeks post-training)
- Cigarette Per Day (CPD)(Up to 8 weeks post-training)
- Wisconsin Smoking Withdrawal Scale (WSWS) - Craving(Up to 8 weeks post-training)
- Urinary Cotinine(Up to 8 weeks post-training)
- Expired Carbon Monoxide (CO)(Up to 8 weeks post-training)