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Recruiting NCT06982443

Wellness, Alcohol, Vitals, and Emotions

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Trial Parameters

Condition Alcohol Use
Sponsor University of New Mexico
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-01
Completion 2027-12-31
Interventions
Mindfulness based relapse prevention

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Brief Summary

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

Inclusion Criteria: 1. 18 years of age or older 2. Meet criteria for a moderate to severe alcohol use disorder within the previous 3-months. 3. Able to attend group meetings at the time listed on the recruitment materials. 4. Willing to wear a sensor for the 8-week intervention period and return the sensor after the immediate follow-up. 5. Have a phone/tablet/computer with internet access. 6. Be able to comprehend and consent to study requirements in English. 7. Have access to a valid U.S. mailing address for receiving the HRV sensors and reside in the United States. Exclusion Criteria: 1. Current symptoms of psychosis or mania. 2. Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification). 3. 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).

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