Digital Mindfulness for Substance Use Disorder Recovery

Overseen By Hedy Kober

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Psychotic disorder, High suicide risk, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

34 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the feasibility and acceptability of a digital mindfulness-based treatment for individuals in early recovery from substance use disorders. Participants are randomized to treatment-as-usual (TAU) or TAU plus the digital mindfulness-based treatment. The digital treatment will be completed over an 8-week period.

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 Digital Mindfulness Treatment for Substance Use Disorder Recovery?

Research shows that mindfulness-based treatments can help people with substance use disorders by reducing cravings and improving mental health. Studies found that attending mindfulness sessions can lead to better outcomes, like increased mindfulness and self-compassion, which are important for recovery. ^{1 2 3 4 5}

Is Digital Mindfulness Treatment safe for humans?

Research on mindfulness-based interventions, including digital mindfulness, suggests they are generally safe for people with substance use disorders, such as opioid dependence. These treatments have shown positive effects on brain function and distress tolerance without reported safety concerns. ^{3 6 7 8 9}

How is Digital Mindfulness Treatment different from other treatments for substance use disorder?

Digital Mindfulness Treatment is unique because it uses mindfulness techniques, which involve focusing on the present moment without judgment, to help people recover from substance use disorders. Unlike traditional treatments, it may involve digital platforms that provide continuous support and resources, making it more accessible and flexible for users. ^{1 2 6 9 10}

Eligibility Criteria

This trial is for adults over 18 who speak English, have finished at least one month of substance use disorder treatment, and used their primary substance within the last six months. They must not be in residential treatment, agree to random assignment, participate fully, provide contact info for follow-up, and own a smartphone with WIFI.

Inclusion Criteria

Have completed 1 month or more of SUD treatment

Report use of their primary substance of choice in past 6 months

Are not currently enrolled in residential/inpatient treatment

Exclusion Criteria

I have thoughts of harming myself with a plan to do so.

Homicidal ideation posing imminent danger to others

Pending legal case, imminent incarceration, or a planned move that results in inability to commit to procedures during the entire study period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either treatment-as-usual (TAU) or TAU plus the digital mindfulness-based treatment over an 8-week period

8 weeks

Weekly outpatient-based group therapy sessions

Post-treatment Assessment

Participants complete post-treatment assessments approximately 9 weeks after randomization

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 2-month post-treatment follow-up assessment

8 weeks

Treatment Details

Interventions

• Digital Mindfulness Treatment
• Treatment-as-Usual (TAU)

Trial Overview The study compares usual recovery treatments with an added digital mindfulness program completed over eight weeks. Participants are randomly placed into either the standard treatment group or the one that includes digital mindfulness exercises.

Participant Groups

Group I: TAU Plus Digital Mindfulness-Based Treatment Experimental Treatment 2 Interventions

TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.

Group II: Treatment-as-Usual (TAU) Active Control 1 Intervention

TAU consists of weekly outpatient-based group therapy

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

Mindfulness-based therapies have shown promising results in reducing substance use in individuals with addictive disorders, with five out of six studies indicating significant reductions in substance use, particularly when follow-up periods were longer.

These interventions not only decreased substance use but also helped participants manage withdrawal-like sensations and emotional responses, suggesting that mindfulness can enhance coping strategies and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness based interventions for addictive disorders: a review]. Skanavi, S., Laqueille, X., Aubin, HJ.[2018]

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]

Participants recovering from alcohol and opioid use disorders found mindfulness-based interventions (MBIs) beneficial for their recovery, particularly valuing the non-pharmacological nature of these therapies.

Key factors influencing participation in MBIs included perceived provider empathy and social connectedness, with participants suggesting that incentives like gift cards could enhance engagement and retention in recovery programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions about mindfulness-based interventions among individuals recovering from opioid and alcohol use disorders: Findings from focus groups. Jones, KO., Lopes, S., Chen, L., et al.[2020]

A mindfulness-based intervention combined with standard outpatient treatment significantly reduced symptoms of depression, anxiety, and anger expression in participants over three months, with 22 individuals in the experimental group and 20 in the control group.

Despite improvements in mental health symptoms, the intervention did not show a significant effect on substance use behavior, indicating the need for further research to explore its overall impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contribution of mindfulness to outpatient substance use disorder treatment in Brazil: a preliminary study. Machado, MP., Fidalgo, TM., Brasiliano, S., et al.[2021]

Mindfulness-based interventions (MBIs) have been found to be as effective as traditional treatments for substance use disorders, helping to reduce the frequency and quantity of substance use, cravings, and related problems based on a systematic review of 30 randomized controlled trials.

The review highlights the need for further large-scale studies to explore the best settings and protocols for MBIs, as well as to identify which patient populations may benefit the most from these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based programs for substance use disorders: a systematic review of manualized treatments. Korecki, JR., Schwebel, FJ., Votaw, VR., et al.[2021]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

In a study of 19 inpatients with opioid dependence, those who received mindfulness-based interventions (MBI) showed significant improvements in distress tolerance and changes in brain structure compared to those receiving standard treatment.

Specifically, MBI was associated with increased strength in brain networks related to impulse control, suggesting that MBI may enhance treatment outcomes for substance use disorders by affecting neural pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions modulate structural network strength in patients with opioid dependence. Fahmy, R., Wasfi, M., Mamdouh, R., et al.[2019]

Mindfulness practice may enhance the effectiveness of substance use prevention programs for youth by promoting brain networks that help delay the initiation of substance use and reduce the risk of developing substance use disorders.

This conceptual paper argues for the need to systematically test mindfulness-based interventions in youth, as they could strengthen protective factors and diminish risk factors associated with substance use, ultimately aiming to prevent future substance misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindful Awareness: Can a Neuro-Developmentally Timed Approach Prevent Youth Substance Misuse. Riggs, NR., Greenberg, MT.[2020]

Mindfulness-based therapy (MBT) significantly increased mindfulness scores in opiate-dependent patients compared to those receiving standard treatment, suggesting its efficacy in enhancing mindfulness during recovery.

Functional MRI results showed that MBT led to specific changes in the connectivity of the default mode network (DMN), particularly decreased connectivity in the right inferior frontal cortex, which was associated with improvements in mindfulness and may help in the treatment of substance-use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy modulates default-mode network connectivity in patients with opioid dependence. Fahmy, R., Wasfi, M., Mamdouh, R., et al.[2020]

An online survey of 123 participants from InTheRooms.com, a recovery-specific social network site, revealed that users found the platform helpful for increasing motivation and self-efficacy in their recovery from substance use disorders, with an average engagement of 30 minutes per day.

Both individuals with less than one year of abstinence and those with more than one year reported similar levels of engagement and perceived benefits from the platform, suggesting that recovery SNSs like ITR could be effective tools for supporting individuals at various stages of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital recovery management: Characterizing recovery-specific social network site participation and perceived benefit. Bergman, BG., Kelly, NW., Hoeppner, BB., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

[Mindfulness based interventions for addictive disorders: a review]. [2018]

2. 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]

3. Scotland pubmed.ncbi.nlm.nih.gov

Perceptions about mindfulness-based interventions among individuals recovering from opioid and alcohol use disorders: Findings from focus groups. [2020]

4. Brazil pubmed.ncbi.nlm.nih.gov

The contribution of mindfulness to outpatient substance use disorder treatment in Brazil: a preliminary study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based programs for substance use disorders: a systematic review of manualized treatments. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions modulate structural network strength in patients with opioid dependence. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Mindful Awareness: Can a Neuro-Developmentally Timed Approach Prevent Youth Substance Misuse. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy modulates default-mode network connectivity in patients with opioid dependence. [2020]

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

Digital recovery management: Characterizing recovery-specific social network site participation and perceived benefit. [2022]