Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Aim 2: Participant Retention
研究概览
简要总结
The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.
详细描述
This study evaluates a mindfulness-based treatment to concurrently target cigarette smoking and alcohol use behaviors in adults.
Aim 1: Modify an existing mindfulness-based treatment to include a focus on smoking cessation and reduced alcohol use.
Aim 2: Evaluate benchmarks regarding the feasibility and acceptability of Mindfulness Based Relapse Prevention -Smoking and Alcohol Use.
Aim 3: Collect and examine descriptive data on proximal and distal variables associated with increased smoking abstinence and reduced drinking.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Currently smoking 3 or more cigarettes per day for the past year.
- •Carbon monoxide level >/= 8 ppm(parts per million); should carbon monoxide level yield a result less than 8 ppm, participant will be asked to submit a urine sample to determine contine levels and the result must be >/ level 3
- •Participant must be motivated to quit smoking and decrease alcohol use within the next 60 days
- •If male, consume >/= 5 drinks and if female consume >/= 4 drinks on at least 1 occasion in the past month
- •Willing and able to attend the 8 weekly group sessions
- •Valid home address in the Tampa Bay area
- •Functioning telephone number
- •Can speak, read and write in English
- •Inclusion Criteria Aim 2:
- •18 years of age or older
- •Currently smoking 3 or more cigarettes per day for the past year.
- •Motivated to quit smoking and decrease alcohol use within the next 60 days
- •If male, consumes >/= 5 drinks and if female consumes >/= 4 drinks on at least 1 occasion in the past month
- •Willingness and ability to attend 8 weekly video group sessions
- •Willingness and ability to use an email account for study materials
- •Valid address
- •Functioning telephone number
- •Can speak, read and write in English
排除标准
- •Unable to wear nicotine patch
- •Participants who have an active substance use disorder other than an alcohol use disorder
- •Participants who have an active psychotic disorder
- •Current use of tobacco cessation medications
- •Pregnant or nursing
- •Participants who have a household member already enrolled in the study.
- •In rare cases, study staff might exclude a participant for a reason not specified here
结局指标
主要结局
Aim 2: Participant Retention
时间窗: End of study at Week 16 Follow-up
Percentage of participants retained through follow-up
Aim 2: Rate of Recruitment of Eligible Participants
时间窗: 20 weeks
Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week
Aim 2: Number of Participants Scoring >3
时间窗: End of Treatment at 8 Weeks
Number of participants scoring \>3. Patient satisfaction will be determined through a score on the Client Satisfaction Questionnaire Version 8 (Attkinson \& Greenfield), where participants respond to 8 items on a 4-point scale (1=very dissatisfied; 4=very satisfied). Results reported indicate clients with a patient satisfaction score over 80%.
Aim 2: Percentage of Participants That Completed Questionnaires
时间窗: End of study at Week 16 Follow-up
Percentage of participants who completed questionnaires at week 16
次要结局
- Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up(At 16 week follow-up)
- Aim 3: Percent of Heavy Alcohol Use at End of Treatment(End of Treatment at 8 Weeks)
- Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up(At 16 week follow-up)
- Aim 3: Percent of Smoking Abstinence End of Treatment(End of Treatment at 8 Weeks)