Clinical trial NCT06074341: TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study
Official title: Mindfulness-Based Relapse Prevention as Video Conferencing Continuing Care to Promote Long Term Recovery From Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol Drinking
Alcohol-Related Disorders
Keywords: mindfulness
recovery
mutual help
harm reduction
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-10-10
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Recovery from AUD
timeFrame: Change from baseline to three year follow-up period
Secondary outcomes:
measure: Reduction in World Health Organization risk drinking levels
timeFrame: Change from baseline to three year follow-up period
measure: PROMIS Alcohol Negative Consequences
timeFrame: Change from baseline to three year follow-up period
measure: PROMIS Preference Score (PROPr)
timeFrame: Change from baseline to three year follow-up period
measure: Penn Alcohol Craving Scale
timeFrame: Change from baseline to three year follow-up period
measure: Alcohol Use Disorder symptoms
timeFrame: Change from baseline to three year follow-up period
measure: Reduction in percent heavy drinking days
timeFrame: Change from baseline to three year follow-up period
measure: Reduction in drinks per drinking day
timeFrame: Change from baseline to three year follow-up period
measure: Reduction in percent drinking days
timeFrame: Change from baseline to three year follow-up period
measure: World Health Organization Quality of Life (WHOQOL - BREF) Measure
timeFrame: Change from baseline to three year follow-up period
measure: Substance Use Moderation Self-Efficacy Scale (SUM-SES)
timeFrame: Change from baseline to three year follow-up period
measure: Addiction Cycle - Negative Emotionality Scale
timeFrame: Change from baseline to three year follow-up period
measure: Addiction Cycle - Incentive Salience Scale
timeFrame: Change from baseline to three year follow-up period
measure: Addiction Cycle - Executive Function Scale
timeFrame: Change from baseline to three year follow-up period
measure: Purpose in Life test
timeFrame: Change from baseline to three year follow-up period
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Katie Witkiewitz
role: PRINCIPAL_INVESTIGATOR
References: