Wellness, Alcohol, Vitals, and Emotions

NCT ID: NCT06982443

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2029-09-01

Brief Summary

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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

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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.

Conditions

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Alcohol Use

Keywords

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alcohol mindfulness harm reduction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBRP

Group Type EXPERIMENTAL

Mindfulness based relapse prevention

Intervention Type 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.

Interventions

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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 ways that are detrimental to their health and happiness.

Intervention Type BEHAVIORAL

Other Intervention Names

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MBRP

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Matison McCool

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matison W McCool, Phd

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Matison W McCool, PhD

Role: primary

Other Identifiers

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K23AA031729

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2407142185

Identifier Type: -

Identifier Source: org_study_id