Wellness, Alcohol, Vitals, and Emotions

NCT06982443 | Recruiting DMC

• 2 other identifiers: 2407142185K23AA031729
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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. 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. 2.How do changes in heart rate variability affect drinking, craving, and negative affectivity in daily life?
3. 3.Answer questions related to their mood and drinking behaviors.
4. 4.Wear their sensors during an 8-week treatment period with 1 group per week.
5. 5.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.

Conditions

Alcohol Use

Keywords

alcohol; mindfulness; harm reduction

Outcome Measures

Primary Outcomes (3)

• 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.

  Change from baseline to 6-month follow-up

• 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.

  Change from baseline to immediate follow-up

• 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.

  Measured 3x daily

Secondary Outcomes (5)

• PROMIS Alcohol Negative Consequences

  Change between baseline and 6-month follow-up

• Penn Alcohol Craving Scale

  Change from baseline to 6-month follow-up/ 3x daily

• Reduction in percent heavy drinking days

  Change from baseline to 6-month follow-up

• Reduction in drinks per drinking day

  Change from baseline to 6-month follow-up

• Daily drinking quantity and frequency

  3x daily during 8-week intervention period

Study Arms (1)

MBRP

EXPERIMENTAL

Behavioral: Mindfulness based relapse prevention

Interventions

Mindfulness based relapse prevention BEHAVIORAL

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 ways that are detrimental to their health and happiness.

Also known as: MBRP

MBRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Harm Reduction

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Matison W McCool, Phd

  Center on Alcohol, Substance use, And Addictions - The University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: At the time of publication of the primary manuscript, or within 12 months of last patient assessment.
• Access Criteria: mplementation of the plan will follow the NIAAA Data Archive and Data Sharing Policy

Locations

US (1)