Mindfulness App for Opioid Dependence and Chronic Pain

Overseen By Corey Roos, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must be taking: Medication-assisted treatment

Disqualifiers: Chronic malignant pain, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a smartphone app called Mindful Journey to determine its effectiveness in aiding recovery from opioid use disorder while managing chronic pain. The researchers aim to assess whether participants find this mindfulness app practical and well-received. This trial suits individuals undergoing medication-assisted treatment for opioid addiction who experience ongoing bothersome pain. Participants will use the app for eight weeks, complete daily check-ins, and receive personalized mindfulness coaching. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery and pain management strategies.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be enrolled in medication-assisted treatment for opioid use disorder to participate.

What prior data suggests that the Mindful Journey app is safe for use in individuals with opioid dependence and chronic pain?

Research has shown that mindfulness-based treatments, like the Mindful Journey app, are generally safe. Studies on similar programs, such as Mindful Recovery and Mindfulness-Oriented Recovery Enhancement, indicate they are well-tolerated. Participants in these studies reported no major side effects. Mindfulness practices in these treatments are considered safe because they emphasize relaxation and awareness. They help manage stress and pain without causing harm. Therefore, the Mindful Journey app is expected to be a safe option for those dealing with opioid use disorder and chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care options for opioid dependence and chronic pain, which often involve medications like methadone or buprenorphine, Mindful Journey offers a non-pharmacological approach. This treatment is unique because it leverages a mobile app to deliver personalized mindfulness coaching directly to users, allowing for constant support and engagement. Researchers are excited about this treatment as it provides a novel way to address both opioid dependence and chronic pain simultaneously, potentially enhancing accessibility and adherence through digital technology. By using real-time data from daily surveys, the app can offer tailored mindfulness exercises, which could lead to more effective management of symptoms compared to traditional methods.

What evidence suggests that the Mindful Journey app is effective for opioid dependence and chronic pain?

Research has shown that mindfulness can reduce cravings for opioids and manage long-term pain. In this trial, participants will use Mindful Journey, a smartphone app that employs mindfulness techniques to focus on the present moment. Studies have found that practicing mindfulness can improve recovery for people dealing with opioid addiction and chronic pain. Early testing of Mindful Journey indicated that users found it easy to use and helpful. The app offers personalized mindfulness coaching to manage daily stress and cravings, supporting individuals in their recovery journey. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English, are in medication-assisted treatment for opioid use disorder, have chronic pain but not from cancer or inflammatory diseases like rheumatoid arthritis, and own a smartphone. Those with psychotic disorders or previous participation in the app's development phase cannot join.

Inclusion Criteria

Fluent in English

Enrollment in medication-assisted treatment for opioid use disorder

Has a smartphone.

Exclusion Criteria

Self-reporting of psychotic disorder symptoms

Participated in the previous phase of the study in which participants provided feedback to inform the development of the Mindful Journey app.

I have long-term pain from cancer or a disease causing body-wide inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants complete a training session to learn about the study procedure and the mobile app platform

1 week

1 visit (in-person or virtual)

Intervention

Participants use the Mindful Journey app for 8 weeks, completing 14 foundational modules and daily check-in surveys. Weekly phone check-ins are conducted to support engagement.

8 weeks

Weekly phone check-ins

Follow-up

Participants complete a series of self-report batteries and participate in a brief exit interview to gather feedback and suggestions for improving the app

1 week

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mindful Journey

Trial Overview

The study tests 'Mindful Journey,' a mindfulness-based smartphone app designed to help individuals managing both opioid addiction and chronic pain. The focus is on seeing if people will find it easy to use and helpful.

How Is the Trial Designed?

Group I: Evaluating the Feasibility and Acceptability of Mindful Journey Prototype Experimental Treatment 1 Intervention

In this single arm trial, participants will complete surveys and interviews about experiences with opioid and other substance use, chronic pain, and treatments, and a brief timeline follow-back assessment for substance use. Participants will also be completing a training session to learn about the study procedure, and the mobile app platform. Participants will enter the intervention period (8-weeks) and complete 14 foundational modules throughout the intervention period using the Mindful Journey app. Daily brief check-in surveys will be completed via the app. Based on these survey responses, participants will receive brief, tailored momentary mindfulness coaching. Study staff will also conduct weekly phone check-ins to support engagement. The final visit will occur following the intervention period and the participant will complete a series of self-report batteries and participate in a brief exit interview to gather feedback and suggestions for improving the app.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

The Mindful Recovery OUD Care Continuum (M-ROCC) program, a 24-week mindfulness-based intervention, significantly reduced comorbid pain and anxiety in patients undergoing buprenorphine treatment, as evidenced by improved scores on various psychological scales and decreased substance use.

Participants showed a notable decrease in positive urine toxicology results for cocaine and benzodiazepines, indicating that M-ROCC may help enhance retention in treatment and prevent substance misuse during opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. Schuman-Olivier, Z., Fatkin, T., Creedon, TB., et al.[2023]

A six-week mindfulness-based stress reduction (MBSR) intervention significantly decreased perceived stress, emotional regulation difficulties, and drug cravings in 15 underserved individuals undergoing treatment for opioid use disorder (OUD).

The results suggest that mindfulness interventions can be effective in improving mental health outcomes for vulnerable populations, highlighting the need for larger studies to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Brief Mindfulness Intervention in Underserved Individuals Receiving Inpatient Treatment for Opioid Use Disorder: A Pilot Study. Kennelly, NR., Ray, S.[2023]

A brief mindfulness-based intervention, consisting of a single 10- to 12-minute session and daily practice, was found to be feasible and well-accepted by 40 patients undergoing outpatient treatment for opioid addiction, with high follow-up completion rates (90% at 6 months).

Patients who engaged in high levels of mindfulness practice (at least 5 minutes daily) experienced significantly lower rates of relapse or treatment failure (11%) compared to those with low practice uptake (42%), suggesting that even short mindfulness training can effectively support recovery from opioid addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Ultra-Brief Mindfulness-Based Intervention for Patients in Treatment for Opioid Addiction with Buprenorphine: A Primary Care Feasibility Pilot Study. Bloom-Foster, J., Mehl-Madrona, L.[2020]

A randomized controlled trial will assess the effectiveness of mindfulness-based relapse prevention (MBRP) for opioid use disorders, involving 240 participants who have completed initial treatment, over an 8-week intervention period.

The study aims to evaluate not only the frequency of opioid use but also various secondary outcomes such as cravings, withdrawal symptoms, and quality of life, while exploring the mechanisms behind MBRP's effectiveness in reducing opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders. Zinzow, H., Shi, L., Rennert, L., et al.[2021]

The pilot study involving 18 adults with Opioid Use Disorder showed that the Mindful Recovery OUD Care Continuum (M-ROCC) was feasible and acceptable, with 89% of participants retained in the program at 4 weeks and 72% at 24 weeks.

Participants demonstrated significant increases in mindfulness over the 24-week period, which correlated with their frequency of mindfulness practice, suggesting that integrating mindfulness-based interventions could enhance retention in buprenorphine/naloxone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. Fatkin, T., Moore, SK., Okst, K., et al.[2023]

Citations

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Mindfulness App for Opioid Dependence and Chronic Pain

Mindful Journey is unique because it uses mindfulness, a mind-body approach that focuses on awareness of the present moment, to help reduce opioid cravings, ...

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This study aimed to iteratively develop and test the initial feasibility and acceptability of Mindful Journey, a novel digital mindfulness-based intervention ...

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In the present study, we will be evaluating a smartphone app-based ecological momentary intervention, called Mindful Journey, for individuals ...

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Mindfulness vs Cognitive Behavioral Therapy for Chronic ...

MBT and CBT were associated with safe improvements in pain and functional outcomes among adults affected with refractory, complex, opioid- ...