Mindfulness-Based Relapse Prevention and Psychophysiological Self-Regulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Recovery from AUD
研究概览
简要总结
The goal of this clinical trial is to examine the effects of mindfulness based relapse prevention on self-regulation overtime and drinking in daily life through the use of wearable heart rate sensors during mindfulness groups and answering assessment questions 3 times per day during the course of treatment. The main questions that it aims to answer are:
- What changes in self-regulation as measured through heart rate variability are observed during a mindfulness intervention and how do those self-regulatory changes affect drinking after treatment?
- How do changes in heart rate variability affect drinking, craving, and negative affectivity in daily life?
Participants will:
- Answer questions related to their mood and drinking behaviors.
- Wear their sensors during an 8-week treatment period with 1 group per week.
- Answer questions 3 times a day during the treatment period. 4.) Return their sensors via a pre-stamped package and answer questions about their mood and drinking behaviors 3- and 6-months after the mindfulness groups end.
详细描述
This study will assess the changes in self-regulation as measured through heart rate variability (HRV), that occur during the course of an 8-week mindfulness-based relapse prevention (MBRP) treatment. The investigators will use a single-group design to test the effects of MBRP on resting, reactivity, and recovery HRV. Additionally, the study will test whether changes in HRV that occur week over week during treatment can affect drinking behaviors in daily life. Individuals (n=120) who meet criteria for moderate to severe alcohol use disorder will be mailed small HRV sensors to be worn before, during, and after each MBRP group. Participants will answer questions about their functioning, alcohol use, addiction cycle domains, and mood at baseline, and at follow-up months 3 and 6.
MBRP groups will be delivered at the same time each week for 8 consecutive weeks, known as the treatment period. During the treatment period, participants will self-attach their sensors before each MBRP group, watch a brief presentation to collect resting HRV, complete their group, and watch a brief presentation after each group. During the treatment period, participants will also answer questions about their drinking, functioning, and mood 3 times a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •18 years of age or older
- •Meet criteria for a moderate to severe alcohol use disorder within the previous 3-months.
- •Able to attend group meetings at the time listed on the recruitment materials.
- •Willing to wear a sensor for the 8-week intervention period and return the sensor after the immediate follow-up.
- •Have a phone/tablet/computer with internet access.
- •Be able to comprehend and consent to study requirements in English.
- •Have access to a valid U.S. mailing address for receiving the HRV sensors and reside in the United States.
排除标准
- •Current symptoms of psychosis or mania.
- •Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
- •Have a history of pulmonary or cardiovascular disease that interferes with sensor data collection and HRV metrics (i.e., ectopic beats, arrythmia, congenital heart disease).
研究组 & 干预措施
MBRP
干预措施: Mindfulness based relapse prevention (Behavioral)
结局指标
主要结局
Recovery from AUD
时间窗: Change from baseline to 6-month follow-up
Recovery is a binary (yes/no) outcome defined by achieving all three of the following: (1) Remission from Diagnostic and Statistical Manual, 5th edition alcohol use disorder (AUD) based on an 11-item AUD symptom checklist (endorsing 0 or 1 item is AUD remission); (2) Cessation of heavy drinking (defined as not engaging in heavy drinking with heavy drinking defined as 4 or more drinks per occasion for females, and 5 or more drinks per occasion for males, measured by the Timeline Follow-Back); and (3) Improvements in functioning and well-being as measured by higher score on the PROMIS PROPr measure. Recovery is achieved if remission, cessation of heavy drinking, and improvements in functioning and well-being are achieved. These assessments will be delivered at Baseline, 3-month, and 6-month follow-ups.
Psychophysiological self-regulation
时间窗: Change from baseline to immediate follow-up
Psychophysiological self-regulation will be measured through three heart rate variability (HRV) domains: HRV at rest (higher RMSSD/HF-HRV indicate higher self-regulation), reactivity HRV (no change, or increases in HRV indicate less reactivity), and recovery HRV (quicker return to resting HRV indicates greater recovery from stress). The three HRV domains will be assessed at baseline, mid-treatment, and immediately following treatment. Tonic HRV is assessed each week before and after the mindfulness group.
Addiction Cycle Domains in Daily Life
时间窗: Measured 3x daily
The negative emotionality domain of the addiction cycle is characterized by temptation to drink in situations when the person is experiencing negative emotions. The Negative Emotionality Scale consists of 2 items scored on a scale from 1=not at all tempted to 5=extremely tempted to drink when experiencing negative emotions. The incentive salience domain of the addiction cycle is characterized by temptation to drink in situations when the person is experiencing rewarding or social pressure to drink. The Incentive Salience Scale consists of 2 items scored on a scale from 1=not at all tempted to 5=extremely tempted to drink when experiencing rewarding, craving, or social situations. The executive function domain of the addiction cycle is characterized by loss of control over drinking. The Executive Scale consists 2 items scored on a scale from 1=indicating more control over drinking to 5=indicating loss. These ecological momentary assessment adapted scales will be delivered 3x per day.
次要结局
- PROMIS Alcohol Negative Consequences(Change between baseline and 6-month follow-up)
- Penn Alcohol Craving Scale(Change from baseline to 6-month follow-up/ 3x daily)
- Reduction in percent heavy drinking days(Change from baseline to 6-month follow-up)
- Reduction in drinks per drinking day(Change from baseline to 6-month follow-up)
- Daily drinking quantity and frequency(3x daily during 8-week intervention period)
研究者
Matison McCool
Research Assistant Professor
University of New Mexico