About this trial
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:
1. 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? 2. How do changes in heart rate variability affect drinking, craving, and negative affectivity in daily life?
Participants will:
1. Answer questions related to their mood and drinking behaviors. 2. Wear their sensors during an 8-week treatment period with 1 group per week. 3. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
Mindfulness based relapse prevention
BehavioralMindfulness-based relapse prevention (MBRP) is a group-based treatment to provide individuals with skills intended to foster increased awareness of triggers, destructive habitual patterns, and "automatic" reactions to triggering experiences. Mindfulness practices in MBRP are designed to help individuals pause, observe present experience, and bring awareness to the range of choices available in every moment. Through MBRP individuals learn to respond in ways that serve them, rather than react in ways that are detrimental to their health and happiness.
Treatment groups
Trial outcomes
Primary outcomes
Recovery from AUD
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
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
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.
Secondary outcomes
PROMIS Alcohol Negative Consequences
The Patient-Reported Outcomes Measurement Information System (PROMIS®) includes 7 items scored from never=1 to almost always=5 that assess negative consequences from alcohol use (e.g., I used poor judgment when I drank). The PROMIS Negative Alcohol Consequences measure will be administered once at baseline, and at follow-up months 3 and 6. Higher scores indicate more negative consequences.
Penn Alcohol Craving Scale
Five item measure of overall craving for alcohol. Responses range from 0 to 6 where 0 represents the absence of the specific craving symptom in the item, and 6 represents the maximum intensity or frequency of the craving symptom in the item. The Penn Alcohol Craving Scale will be administered once at baseline, and at follow-up months 3 and 6. Higher scores on the Penn Alcohol Craving Scale reflect more severe alcohol craving. An adapted version of the craving scale will be used 3x daily to assess momentary craving
Reduction in percent heavy drinking days
Percent heavy drinking days will be calculated using the Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 90 days. This measure will be used to identify the total number of occasions of daily heavy drinking (defined as 4 or more drinks for females and 5 or more drinks for males), and the percent heavy drinking days will be calculated as the number of heavy drinking days in the past 90 days divided by the total number of days in that time period (typically 90 days, unless some days are missing). The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 3 and 6. Higher percent heavy drinking days indicate more heavy drinking occasions in a 90-day period.
Reduction in drinks per drinking day
Drinks per drinking day will be calculated using the Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 90 days. This measure will be used to identify the total number of drinks consumed on each drinking day, and the number of drinks per drinking drinking days will be calculated as the total number of drinks consumed in the past 90 days divided by the total number of days in that time period when drinking occurred (typically 90 days, unless some days are missing). The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 3 and 6. Higher drinks per drinking day indicates greater intensity of drinking in a 90-day period.
Sponsors and contacts
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University of New Mexico
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator