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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of mindfulness-based relapse prevention (MBRP) therapy delivered through video calls, compared to online mutual support groups, in helping individuals with alcohol use disorder (AUD) reduce or stop drinking. The trial aims to support long-term recovery by focusing on the whole person, including the brain's role in addiction. Individuals who have received treatment for AUD or recently tried to cut back on drinking may find this trial suitable, especially if they have experienced heavy drinking episodes in the past six months. Participants should be comfortable using a smartphone or tablet with internet access. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery options for many.

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 prior data suggests that these methods are safe for individuals with alcohol use disorder?

Research has shown that mindfulness-based relapse prevention (MBRP) is generally safe. Studies have found that MBRP can reduce cravings and improve emotional regulation in individuals dealing with substance use issues. These studies reported no major negative effects, indicating that the treatment is well-tolerated.

The treatment includes mindfulness practices, which are mental exercises that focus on the present moment. Participants in MBRP sessions often feel more in control of their cravings and emotions, aiding in recovery. No serious side effects are associated with mindfulness practices.

In summary, evidence suggests that MBRP is safe and may be helpful for managing alcohol use disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TeleHealth Resources for Alcoholism trial because it explores innovative approaches to support recovery. Unlike traditional face-to-face therapy, the mindfulness-based relapse prevention (MBRP) treatment leverages digital tools by offering a smartphone app, Thrive Recovery, that provides audio-guided mindfulness practices. This approach allows participants to integrate mindfulness into their daily routines, making recovery more accessible and personalized. Meanwhile, the referral to online mutual support groups provides a flexible alternative to in-person meetings, offering individuals the convenience of accessing groups like SMART Recovery or Alcoholics Anonymous from anywhere. These methods aim to make support more readily available and adaptable to individual needs, potentially enhancing the recovery process.

What evidence suggests that this trial's treatments could be effective for alcohol use disorder?

Research has shown that mindfulness-based relapse prevention (MBRP), one of the treatments in this trial, can assist individuals with substance use issues, such as alcohol use disorder. Studies found that participants in MBRP were less likely to resume substance use or heavy drinking compared to those receiving regular treatment. Participants also reported fewer cravings and less frequent substance use. Although adding MBRP to regular care did not aid some early recovery cases, it remains promising for long-term recovery. This method emphasizes mindfulness, helping individuals become more aware of their thoughts and cravings, which can be crucial for maintaining sobriety. Another treatment arm in this trial involves referral to online mutual support groups, providing participants with access to virtual meeting options like SMART Recovery and Alcoholics Anonymous (AA). ^{2 6 7 8 9}

Who Is on the Research Team?

Katie Witkiewitz, PhD

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8533446/

Effectiveness of Mindfulness-Based Relapse Prevention in ... Results support the effectiveness of these interventions in the SUD population, especially in reducing cravings, decreasing the frequency of use, and improving ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875923001674

Efficacy of mindfulness-based relapse prevention in a ... At the 6-month follow up, participants assigned to MBRP and RP, compared to TAU, reported significantly lower risk of relapse to substance use (54 %) and heavy ...

3. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/1839290

Relative Efficacy of Mindfulness-Based Relapse ... Compared with TAU, participants assigned to MBRP and RP reported significantly lower risk of relapse to substance use and heavy drinking.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6508889/

Mindfulness-Based Relapse Prevention for Alcohol ... CONCLUSIONS: MBRP-A as an adjunct to usual-care did not show to improve outcomes in alcohol-dependent adults in early recovery compared to usual ...

5. mindfulrp.com mindfulrp.com/research

Research Below are summaries of sample journal articles assessing the efficacy, effectiveness and mechanisms of mindfulness-based approaches to addictions treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5636047/

Mindfulness-based Relapse Prevention for Substance Use ... We have limited confidence in estimates suggesting MBRP yields small effects on withdrawal/craving and negative consequences versus comparator interventions.

7. rand.org rand.org/pubs/research_reports/RR1031.html

Mindfulness-Based Relapse Prevention for Substance Use ... Outcomes of interest included relapse, frequency and quantity of substance use, withdrawal/craving symptoms, treatment dropout, functional ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3280682/

Mindfulness-Based Relapse Prevention for Substance Use ... Initial efficacy was supported by significantly lower rates of substance use in those who received MBRP as compared to those in TAU over the 4-month post- ...

9. brieflands.com brieflands.com/journals/jhrt/articles/136888

Effects of Mindfulness-Based Relapse Prevention Therapy ... According to the results, MBRP effectively reduced drug cravings and improved the emotion regulation of participants in the experimental group.