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

University of New Mexico (UNM)

Status: Active, not recruiting

Conditions: Alcohol Use Disorder; Alcohol-Related Disorders; Alcohol Drinking

Treatments: Behavioral: Online Mutual Support Groups; Behavioral: Mindfulness-based relapse prevention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06074341

2212028742

R01AA031159 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 470 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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470 participants in 2 patient groups

Mindfulness-based relapse prevention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-based relapse prevention

Referral to online mutual support groups

Active Comparator group

Description:

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.

Treatment:

Behavioral: Online Mutual Support Groups