TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study (THRIVE)

December 22, 2025 updated by: University of New Mexico

Mindfulness-Based Relapse Prevention as Video Conferencing Continuing Care to Promote Long Term Recovery From Alcohol Use Disorder

This project will evaluate the effectiveness and mechanisms of mindfulness-based relapse prevention (MBRP) delivered via video conferencing, as compared to referral to online mutual support groups, in supporting long-term whole-person recovery and improvements in neurobiologically-informed domains of addiction among individuals with alcohol use disorder who are interested in reducing or stopping drinking. The project will also examine the reach, effectiveness, adoption, implementation, and maintenance of MBRP as an accessible and freely available continuing care option that supports long-term recovery from alcohol use disorder in all communities nationwide, including medically underserved and health professional shortage areas.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this study is to examine the effectiveness of mindfulness-based relapse prevention (MBRP) groups delivered via Zoom in promoting whole-person recovery from alcohol use disorder, and to examine how MBRP affects mechanisms of behavior change based on neurobiologically-informed addiction cycle domains. The investigators will use a hybrid effectiveness-implementation design to prospectively test the effectiveness of MBRP, as well as identify barriers and facilitators of MBRP group participation to inform future implementation of MBRP continuing care. Individuals (n=430) who have recently engaged in a change attempt to stop or reduce their drinking (via treatment or self-change) will be randomized to either MBRP groups via Zoom or referral to online mutual support. Participants will complete measures of psychosocial functioning, alcohol and other drug use, addiction cycle domains, and previously established predictors of recovery every 6 months for 3 years. Using a mixed methods design in the MBRP group, the investigators will examine facilitators and barriers to participation and engagement in MBRP, and assess the reach, effectiveness, adoption, implementation, and maintenance of MBRP via Zoom as continuing care in communities nationwide.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
470

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Katie Witkiewitz, PhD
  • Phone Number: 505-226-5252
  • Email: katiew@unm.edu

Study Contact Backup

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • At least 18 years old
  • Received AUD treatment or made a self-change attempt to reduce or stop drinking in the past 3 months or is interested in reducing or stopping drinking
  • Meet criteria for a current AUD
  • Engaged in heavy drinking (more than 14 standard drinks per week or more than 4 drinks on a single day for men and more than 7 drinks per week or more than 3 drinks on a single day for women) in the past 6-months
  • Able to understand all study procedures and able to consent in English or Spanish.
  • Be willing to use a personal smart phone or tablet that is connected to the internet, or being willing to use a study-provided tablet
  • Have access to a valid U.S. mailing address for receiving dried blood spot card or blood collection device.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness-based relapse prevention
The MBRP condition will be based on an existing rolling group treatment manual, which consists of eight 60-minute sessions. Each session will begin with a brief mindfulness practice and a discussion of "what is mindfulness?" and the role mindfulness may play in recovery. The themes are repeated every eight sessions, but in every session the participant is bringing a new direct moment experience to the practices in that session. The groups will also consist of people in various stages of recovery and familiarity with the material, which can make for richer discussions of the material led by the group members themselves. Participants who are randomized to receive rolling MBRP treatment will also have access to the Thrive Recovery smart phone app, which includes audio-guided MBRP meditations for participants to practice in daily life.
Behavioral: 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.
Active Comparator: Referral to online mutual support groups
The referral group will consist of a brief 1:1 meeting with a research team member who will provide an orientation to online mutual support and discuss the SMART Recovery, Alcoholics Anonymous (AA), and other virtual meeting options and to discuss how to access mutual support via these platforms. Individuals will also have an opportunity to review the process of attending online groups, and will discuss technology issues that might arise during groups. The session will be 20-30 minutes in length.
Behavioral: Online Mutual Support Groups
Mutual support groups are free, peer-led organizations that are designed to help individuals with substance use disorders and other addiction-related problems. Mutual support groups often focus on communication and exchange of addiction and recovery experience and skills. Individuals participate in activities that engage, educate, and support patients recovering from substance use disorder from others facing similar challenges. Mutual help organizations that will be offered as referrals include: Alcoholics Anonymous (AA), In The Rooms, and SMART Recovery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recovery from AUD
Time Frame: Change from baseline to three year follow-up period
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 over the past 28 days 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 World Health Organization Quality of Life domain scores (each of 26 items scored from 1 to 5 on a response scale, which are then transformed linearly to a 0-100-scale) and the 36-item Short Form Health Survey Mental Health Component Score (scored on a 0-100 scale). Recovery is achieved if remission, cessation of heavy drinking, and improvements in functioning and well-being are achieved.
Change from baseline to three year follow-up period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS Alcohol Negative Consequences
Time Frame: Change from baseline to three year follow-up period
The Patient-Reported Outcomes Measurement Information System (PROMIS®) includes 7 items scored from never=1 to almost always=5 that assess negative consequences from alcohol use (e.g., I used poor judgment when I drank). The PROMIS Negative Alcohol Consequences measure will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate more negative consequences.
Change from baseline to three year follow-up period
PROMIS Preference Score (PROPr)
Time Frame: Change from baseline to three year follow-up period
PROPr combines scores from 7 PROMIS domains (cognitive function, depression, fatigue, pain interference, physical function, ability to participate in social roles and activities, and sleep disturbance) into a single health utility score. The PROMIS PROPr will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate better health.
Change from baseline to three year follow-up period
Penn Alcohol Craving Scale
Time Frame: Change from baseline to three year follow-up period
Five item measure of overall craving for alcohol. Responses range from 0 to 6 where 0 represents the absence of the specific craving symptom in the item, and 6 represents the maximum intensity or frequency of the craving symptom in the item. The Penn Alcohol Craving Scale will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores on the Penn Alcohol Craving Scale reflect more severe alcohol craving.
Change from baseline to three year follow-up period
Alcohol Use Disorder symptoms
Time Frame: Change from baseline to three year follow-up period
Total number of symptoms endorsed (yes or no) on an 11-item checklist of the symptoms of alcohol use disorder experienced in the past 12-months (baseline) and past 6-months (at 6-month follow-up assessments). The Alcohol Use Disorder Symptom checklist will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate more symptoms of alcohol use disorder.
Change from baseline to three year follow-up period
World Health Organization Quality of Life (WHOQOL - BREF) Measure
Time Frame: Change from baseline to three year follow-up period
The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The WHOQOL - BREF will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores on the WHOQOL-BREF reflect greater quality of life.
Change from baseline to three year follow-up period
Substance Use Moderation Self-Efficacy Scale (SUM-SES)
Time Frame: Change from baseline to three year follow-up period
The SUM-SES is a 12-item questionnaire that asks participants to indicate on a 0% to 100% scale regarding how confident they are that they would be able to resist drinking beyond their limit in a given situation. The SUM-SES will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores on the SUM-SES reflect greater confidence to resist drinking beyond one's limit.
Change from baseline to three year follow-up period
Addiction Cycle - Negative Emotionality Scale
Time Frame: Change from baseline to three year follow-up period
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 4 items scored on a scale from 1=not at all tempted to 5=extremely tempted to drink when experiencing negative emotions. The Addiction Cycle Negative Emotionality scale will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate a greater tendency to be tempted to drink in situations characterized by negative emotions.
Change from baseline to three year follow-up period
Addiction Cycle - Incentive Salience Scale
Time Frame: Change from baseline to three year follow-up period
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 4 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 Addiction Cycle Incentive salience scale will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate a greater tendency to be tempted to drink in situations characterized by reward, craving, and social pressure.
Change from baseline to three year follow-up period
Addiction Cycle - Executive Function Scale
Time Frame: Change from baseline to three year follow-up period
The executive function domain of the addiction cycle is characterized by loss of control over drinking. The Executive Scale consists of 1 binary yes/no item ("After taking one or two drinks, can you usually stop?") and 4 items scored on a scale from 1=indicating more control over drinking to 5=indicating loss of control over drinking. The Addiction Cycle Executive Function scale will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate more impaired executive function and greater loss of control over drinking.
Change from baseline to three year follow-up period
Purpose in Life test
Time Frame: Change from baseline to three year follow-up period
The Purpose in Life test is a 20 item measure of experiencing meaning and purpose in one's life, with each item assessed on a 1 (lack of meaning) to 7 (full of meaning) Likert-type scale. The Purpose in Life test will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate more meaning and purpose in life.
Change from baseline to three year follow-up period
Reduction in World Health Organization risk drinking levels
Time Frame: Change from baseline to three year follow-up period
The Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 28 days will be used to calculate the World Health Organization risk levels based on sex specific grams of alcohol consumed per day in the 28 days prior to the assessment, with levels defined as: low risk (0-20 females/0-40 males), moderate risk (21-40 females, 41-60 males), high risk (41-60 females, 61-100 males), and very high risk (61+ females/100+ males) we will examine those who achieve at least a 1-level and at least a 2-level reduction in risk drinking levels. The reference group for the 1-level reduction is no change or increase in WHO risk drinking level and the reference group for the 2-level reduction is 1-level reduction, no change, or increase in WHO risk drinking level. The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36.
Change from baseline to three year follow-up period
Reduction in percent heavy drinking days
Time Frame: Change from baseline to three year follow-up period
Percent heavy drinking days will be calculated using the Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 28 days. This measure will be used to identify the total number of occasions of daily heavy drinking (defined as 4 or more drinks for females and 5 or more drinks for males), and the percent heavy drinking days will be calculated as the number of heavy drinking days in the past 28 days divided by the total number of days in that time period (typically 28 days, unless some days are missing). The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher percent heavy drinking days indicate more heavy drinking occasions in a 28-day period.
Change from baseline to three year follow-up period
Reduction in drinks per drinking day
Time Frame: Change from baseline to three year follow-up period
Drinks per drinking day will be calculated using the Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 28 days. This measure will be used to identify the total number of drinks consumed on each drinking day, and the number of drinks per drinking drinking days will be calculated as the total number of drinks consumed in the past 28 days divided by the total number of days in that time period when drinking occurred (typically 28 days, unless some days are missing). The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher drinks per drinking day indicates greater intensity of drinking in a 28-day period.
Change from baseline to three year follow-up period
Reduction in percent drinking days
Time Frame: Change from baseline to three year follow-up period
Percent drinking days will be calculated using the Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 28 days. This measure will be used to identify the total number of occasions of drinking, and the percent drinking days will be calculated as the number of drinking days in the past 28 days divided by the total number of days in that time period (typically 28 days, unless some days are missing). The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher percent drinking days indicate greater frequency of drinking in a 28-day period.
Change from baseline to three year follow-up period
PROMIS Meaning and Purpose measure
Time Frame: Change from baseline to three year follow-up period
The Patient-Reported Outcomes Measurement Information System (PROMIS®) Meaning and Purpose measure includes 8 items scored from not at all=1 to very much=5 that assess one's sense that life has purpose and there are good reasons for living (e.g., My life has meaning). The PROMIS Meaning and Purpose measure will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate greater purpose in life
Change from baseline to three year follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of New Mexico

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katie Witkiewitz, University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2212028742
  • R01AA031159 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will comply with all NIAAA Data Archives policies established during the project period. This includes compliance with the NIAAA central data platform requirements and timelines developed through the NIAAA Data Share.

IPD Sharing Time Frame

At the time of publication of the primary manuscript, or within 12 months of last patient assessment.

IPD Sharing Access Criteria

Implementation of the plan will follow the NIAAA Data Archive and Data Sharing Policy

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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