Exploring the Feasibility and Acceptability of Brief Mindfulness Training With Vagal Nerve Stimulation for Reducing Alcohol Consumption Among Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
The present study will assess the acceptability and feasibility of a brief intervention designed to help young heavy drinkers reduce their alcohol consumption. All participants will complete a brief (1-week) mindfulness intervention, and participants will be randomized to receive either active or inactive Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) during two in-person laboratory visits. Heart rate variability data and self-report survey data will be collected to assess the impact of the intervention on autonomic regulation, alcohol consumption, and additional clinical measures.
详细描述
After consenting to participate in the study, participants will complete a baseline survey battery online via REDCap while with the Research Coordinator/Research Assistant (RC/RA) in the consent/screening call. During this call, the RC/RA will also schedule the participant's two in-person lab visits. The first lab visit will be scheduled for approximately one week from the consent call, but no more than two weeks from the consent call and baseline survey battery. The second lab visit will take place 1 week after the first lab visit +/- 3 business days if the participant or study team need to reschedule for any reason. Participants will attend a final virtual visit on Zoom or Google Meets 1 week (+/- 3 business days) after the second lab visit to complete follow-up surveys via REDCap.
A trained RC/RA will run participants through lab visits 1 and 2, and at least one senior study team member will be present in the Center for Mindfunless and Compassion (CMC) office space during the visit so that they are available to help troubleshoot if issues arise with the RAVANS stimulation set-up.
During lab visit 1, participants will: complete a 30-minute survey battery via REDCap on a study computer, engage in four 5-minute resting periods for heart rate variability measurements spaced throughout the session, complete a fit test to set up the RAVANS device and ear electrode, and engage in a drinking-related stimuli exposure task including visual cues. After visual cues participants will have initial 10 minute exposure to either active or inactive RAVANS stimulation based on randomization. Additionally, participants will complete a short set of surveys at the end of the visit.
During lab visit 2, participants will: complete a 30-minute survey battery via REDCap on a study computer, engage in four 5-minute resting periods for heart rate variability measurements spaced throughout the session, complete a 30-minute session with active or inactive RAVANS while listening to a mindful breathing audio recording. Participants will be exposed to visual drinking related cues twice: once without the RAVANS device and once with the RAVANS device (active or inactive depending on randomization status). Additionally, participants will complete a short set of surveys at the end of the visit.
Survey Battery:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to their randomization status. All other study personnel will remain unblinded so that they can administer the active or inactive stimulation and address any technical issues or other concerns that may arise around the use of the RAVANS device.
入排标准
- 年龄范围
- 21 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently living in Massachusetts.
- •Aged 21-29 years old.
- •Consume either more than 14 standard drinks of alcohol per week OR at least 5 standard drinks in one day per week (in past 30 days).
- •Have sufficient English fluency to understand procedures and questionnaires.
- •Have the capacity and ability to provide informed consent.
- •Scores at least 15 points on the PACS at screening. Participants who score between 10 and 14 pts will undergo additional doctoral-level review to assess eligibility.
排除标准
- •Current or past diagnosis of a substance use disorder based on the Quick Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Module C (Substance Use Disorders).
- •Active prescription for sedative/hypnotics, opioids, or anesthetic medications.
- •Active prescription for medications used to treat alcohol use disorder (AUD), e.g., naltrexone, disulfiram, acamprosate, etc.
- •Active psychosis or schizophrenia-spectrum disorder diagnosis.
- •Bipolar I disorder history or severe level of mania.
- •Severe symptoms of PTSD.
- •Acute suicidality or self-injurious behavior.
- •Cognitive inability as demonstrated by the inability to complete an informed consent assessment with >90% accuracy after 2 attempts.
- •Current participation in another experimental intervention research study.
- •Current daily mindfulness practice >10 minutes per day.
- •Participation in an 8-week intensive Mindfulness-Based Intervention or residential meditation retreat in past 3 years.
- •Expected medical hospitalization in the next 2 months; or are currently pregnant.
- •Expected incarceration in the next 2 months.
- •Presence of electronic implants, such as heart pacemakers, defibrillators, or pumps.
- •Presence of a cardiac rhythm disorder.
- •History of seizures.
- •Presence of skin disorders or malignant diseases in the area in or around the left ear.
- •Lack of alcohol craving as assessed by the PACS during screening (score of < 10 points).