TeleHealth Resources for Alcoholism

(THRIVE Trial)

Overseen By Megan Kirouac

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Psychosis, Mania, Severe substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 8 weeks

470 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Mindfulness-based relapse prevention (MBRP) for alcoholism?

Research shows that Mindfulness-based relapse prevention (MBRP) is effective for substance use disorders, with studies indicating it helps reduce substance use and cravings, and increases awareness and acceptance. Although specific data for alcoholism is not provided, these findings suggest MBRP could be beneficial for alcohol-related issues as well. ^{1 2 3 4 5}

Is Mindfulness-Based Relapse Prevention (MBRP) safe for humans?

Research on Mindfulness-Based Relapse Prevention (MBRP) for substance use disorders suggests it is generally safe for humans, as it is a group-based therapy that combines mindfulness practices with cognitive-behavioral techniques, and no safety concerns have been reported in the studies reviewed. ^{1 2 4 6 7}

How is the treatment Mindfulness-based relapse prevention (MBRP) for alcoholism different from other treatments?

Mindfulness-based relapse prevention (MBRP) is unique because it combines mindfulness practices with cognitive-behavioral strategies to help individuals become more aware of their cravings and triggers, promoting better self-control and reducing the risk of relapse. Unlike traditional treatments, MBRP focuses on enhancing psychological flexibility and mindfulness, which can improve mental health and reduce cravings. ^{1 2 5 8 9}

What is the purpose of this trial?

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.

Research Team

Katie Witkiewitz, PhD

Principal Investigator

University of New Mexico

Eligibility Criteria

This trial is for adults over 18 with alcohol use disorder (AUD) who have tried to reduce or stop drinking in the last 3 months. Participants must be willing to use a smart device, understand English or Spanish, and not require inpatient detoxification. They should also not have severe mental health issues like psychosis or mania.

Inclusion Criteria

You have consumed more than the recommended amount of alcoholic beverages in the last 6 months for your gender.

You are prepared to utilize a personally-owned smart device with internet connectivity, or you consent to the utilization of a tablet provided by the research.

You possess the capability to receive a dried blood spot card or blood collection device at an acceptable U.S

Exclusion Criteria

I am currently experiencing symptoms of psychosis or mania.

You have a serious problem with drugs or alcohol that requires more intensive treatment than just going to a regular doctor's appointment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in Mindfulness-Based Relapse Prevention (MBRP) via Zoom, consisting of eight 60-minute sessions, repeated every eight sessions.

8 weeks

8 sessions (virtual)

Follow-up

Participants are monitored for psychosocial functioning, alcohol use, and addiction cycle domains every 6 months for 3 years.

36 months

6 visits (virtual)

Open-label extension (optional)

Participants may continue to use the Thrive Recovery app for ongoing mindfulness practice.

Long-term

Treatment Details

Interventions

• Mindfulness-based relapse prevention
• Online Mutual Support Groups

Trial Overview The THRIVE study tests if mindfulness-based relapse prevention via video conferencing helps long-term recovery from AUD compared to online support groups. It looks at how well this method works across communities, including underserved areas.

Participant Groups

Group I: Mindfulness-based relapse prevention Experimental Treatment 1 Intervention

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.

Group II: Referral to online mutual support groups Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

Mindfulness-based relapse prevention (MBRP) is more effective than relapse prevention (RP) for reducing drug use days, especially in therapy groups where at least one-third of the participants are women, based on a study of 186 individuals with substance use disorders.

The analysis found that while individual gender did not affect treatment outcomes, the gender composition of the group significantly influenced the efficacy of MBRP, leading to complete abstinence from drugs for all participants in mixed-gender groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual gender and group gender composition as predictors of differential benefit from mindfulness-based relapse prevention for substance use disorders. Roos, C., Stein, E., Bowen, S., et al.[2022]

Mindfulness-based relapse prevention (MBRP) and cognitive-behavioral relapse prevention (RP) significantly reduced the risk of relapse to substance use and heavy drinking compared to treatment as usual (TAU) during a 12-month follow-up with 286 participants.

At the 12-month mark, MBRP participants reported fewer days of substance use and heavy drinking compared to both RP and TAU, suggesting that mindfulness practices can enhance long-term recovery outcomes by helping individuals manage cravings and negative emotions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. Bowen, S., Witkiewitz, K., Clifasefi, SL., et al.[2022]

The study involved 168 adults with substance use disorders and evaluated an 8-week Mindfulness-Based Relapse Prevention (MBRP) program, showing it was feasible with high participant satisfaction and good homework compliance.

Participants in the MBRP program had significantly lower rates of substance use and greater improvements in craving management and mindfulness skills compared to those receiving standard treatment as usual (TAU) over a 4-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Bowen, S., Chawla, N., Collins, SE., et al.[2022]

An eight-week mindfulness-based relapse prevention (MBRP) program was tested on 20 cannabis users, but preliminary results showed no significant difference in the number of joints smoked compared to those receiving standard treatment.

Despite the lack of significant quantitative results, many participants in the MBRP group reported positive qualitative changes in their cannabis consumption, suggesting that mindfulness may still play a beneficial role in managing substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for cannabis regular users: Preliminary outcomes of a randomized clinical trial. Schneegans, A., Bourgognon, F., Albuisson, E., et al.[2022]

Mindfulness-based relapse prevention (MBRP) was effective in reducing craving, anxiety, and depression among individuals receiving medication for opioid use disorder (MOUD), with significant improvements observed over 36 weeks.

Participants in the MBRP group showed similar retention and relapse rates compared to those receiving treatment as usual (TAU), suggesting that MBRP can be a beneficial outpatient therapy alongside MOUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing Mindfulness-Based Relapse Prevention with Medications for Opioid Use Disorder Among Adults in Outpatient Therapy: a Quasi-experimental Study. Zullig, KJ., Lander, LR., Tuscano, M., et al.[2022]

The study is a two-site, randomized controlled trial comparing Mindfulness-Based Relapse Prevention (MBRP) to 12-Step Facilitation (TSF) in military Veterans who have completed intensive outpatient treatment for substance use disorders, with an 8-week intervention followed by long-term follow-ups.

The primary goal is to determine if MBRP is more effective than TSF in preventing relapse and improving recovery outcomes, including quality of life and mental health, in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of mindfulness-based relapse prevention in veterans with substance use disorders: Design and methodology of a randomized clinical trial. Brady, KT., Killeen, T., Baker, NL.[2021]

Mindfulness-based Relapse Prevention (MBRP) showed small positive effects on withdrawal and craving symptoms in individuals with substance use disorders, based on a review of 9 randomized controlled trials involving 901 participants.

However, MBRP did not demonstrate significant differences in relapse rates, frequency of substance use, or other mental health outcomes compared to other treatments, indicating that while it may help with cravings, its overall efficacy remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. Grant, S., Colaiaco, B., Motala, A., et al.[2023]

The Mindfulness-Based Relapse Prevention (MBRP) program, involving 52 participants with alcohol use disorder, demonstrated good acceptability and feasibility, with an average of 6.6 out of 8 sessions completed.

Participants reported significant improvements in craving, psychological flexibility, and mindfulness, along with reductions in alcohol use, depression, and anxiety after 6 months, indicating the program's potential effectiveness in supporting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and preliminary outcomes of a mindfulness-based relapse prevention program in a naturalistic setting among treatment-seeking patients with alcohol use disorder: a prospective observational study. von Hammerstein, C., Khazaal, Y., Dupuis, M., et al.[2020]

Rolling Mindfulness-Based Relapse Prevention (MBRP) is feasible and acceptable for adults in short-term residential treatment for substance use disorders, with good attendance and high satisfaction reported among participants.

Attending more than one session of Rolling MBRP significantly improved mental health and mindfulness at discharge, suggesting that mindfulness practice is a crucial mechanism that enhances the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open trial of rolling admission mindfulness-based relapse prevention (Rolling MBRP): feasibility, acceptability, dose-response relations, and mechanisms. Roos, C., Kirouac, M., Stein, E., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Individual gender and group gender composition as predictors of differential benefit from mindfulness-based relapse prevention for substance use disorders. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for cannabis regular users: Preliminary outcomes of a randomized clinical trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Testing Mindfulness-Based Relapse Prevention with Medications for Opioid Use Disorder Among Adults in Outpatient Therapy: a Quasi-experimental Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of mindfulness-based relapse prevention in veterans with substance use disorders: Design and methodology of a randomized clinical trial. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and preliminary outcomes of a mindfulness-based relapse prevention program in a naturalistic setting among treatment-seeking patients with alcohol use disorder: a prospective observational study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

An open trial of rolling admission mindfulness-based relapse prevention (Rolling MBRP): feasibility, acceptability, dose-response relations, and mechanisms. [2020]