Mindfulness relapse prevention that tracks heart rate and mood for people with alcohol problems.

Mindfulness-Based Relapse Prevention and Psychophysiological Self-Regulation

This program tests whether an 8-week mindfulness-based relapse prevention course plus wearable heart-rate sensors and three daily surveys can reduce drinking and improve self-regulation in adults with moderate to severe alcohol use disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of New Mexico (Academic / other)
• Locations: 1 site (Albuquerque, New Mexico)
• Trial ID: NCT06982443 on ClinicalTrials.gov

What this trial studies

This single-group study enrolls 120 adults with moderate to severe alcohol use disorder to receive eight weekly mindfulness-based relapse prevention (MBRP) groups. Participants are mailed wearable heart-rate variability (HRV) sensors to wear before, during, and after each weekly group and complete three brief surveys per day during the treatment period. Investigators will measure resting, reactivity, and recovery HRV week-to-week and link changes in HRV to daily drinking, craving, and negative affect. Participants also complete baseline and 3- and 6-month follow-ups to track drinking outcomes after treatment.

Who should consider this trial

Good fit: Adults 18 or older in the United States who meet criteria for moderate to severe alcohol use disorder, can read English, have internet access and a U.S. mailing address, can attend weekly group sessions, and are willing to wear and return the HRV sensor are ideal candidates.

Not a fit: People with current psychosis or mania, those requiring inpatient detoxification or higher-level substance use care, or individuals with cardiac conditions that interfere with HRV data collection may not benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could help identify physiological signs of poor self-regulation and reduce drinking by timing or tailoring relapse-prevention strategies.

How similar studies have performed: Mindfulness-based relapse prevention has shown promise in reducing relapse and cravings in prior trials, while using wearable HRV monitoring in this context is an emerging approach with limited prior large-scale evidence.

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).

Where this trial is running

Albuquerque, New Mexico

• University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)

Study contacts

• Principal investigator: Matison W McCool, Phd — Center on Alcohol, Substance use, And Addictions - The University of New Mexico

Conditions Alcohol Use; alcohol; mindfulness; harm reduction