Wellness, Alcohol, Vitals, and Emotions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness based relapse prevention.
- Who it may be relevant to
- Registry conditions: Alcohol Use. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mindfulness-Based Relapse Prevention and Psychophysiological Self-Regulation
Overview
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.
Detailed description
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.
Interventions
- Behavioral Mindfulness based relapse prevention
Mindfulness-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 w
Primary outcome measures
- Recovery from AUD [Time frame: Change from baseline to 6-month follow-up]
- Psychophysiological self-regulation [Time frame: Change from baseline to immediate follow-up]
- Addiction Cycle Domains in Daily Life [Time frame: Measured 3x daily]
Secondary outcome measures (5)
- PROMIS Alcohol Negative Consequences [Time frame: Change between baseline and 6-month follow-up]
- Penn Alcohol Craving Scale [Time frame: Change from baseline to 6-month follow-up/ 3x daily]
- Reduction in percent heavy drinking days [Time frame: Change from baseline to 6-month follow-up]
- Reduction in drinks per drinking day [Time frame: Change from baseline to 6-month follow-up]
- Daily drinking quantity and frequency [Time frame: 3x daily during 8-week intervention period]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of New Mexico — Albuquerque
Identifiers
NCT: NCT06982443 · 2407142185 · K23AA031729