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: Rate of Recruitment of Eligible Participants
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
研究组 & 干预措施
Mindfulness Based Relapse Prevention
Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).
干预措施: Mindfulness Based Relapse Prevention - Smoking and Alcohol (Behavioral)
Cognitive Behavioral Therapy
Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
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: Participant Retention
时间窗: End of study at Week 16 Follow-up
Percentage of participants retained through follow-up
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: Percent of Heavy Alcohol Use at End of Treatment(End of Treatment at 8 Weeks)
- Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up(At 16 week follow-up)
- 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)