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Recruiting
NCT06982443
Wellness, Alcohol, Vitals, and Emotions
Conditions: Alcohol Use
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: University of New Mexico
Location: University of New Mexico Albuquerque New Mexico
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).
Source: ClinicalTrials.gov (NCT06982443). StuddyBuddy aggregates publicly available trial information.