MINDFUL-OBOT: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment

Study Overview
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Brief Summary
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The goal of this pilot study is to test the Mindful Recovery OBOT Care Continuum (M-ROCC) model in primary care office-based opioid treatment (OBOT). M-ROCC features integration of evidence-based mindfulness training with weekly group-based opioid treatment. Primary outcomes include (1) Feasibility measured by implementation of the curriculum into two CHA primary care sites and attendance at weekly sessions; (2) Acceptance via self-report and qualitative interviews. Secondary outcomes include anxiety reduction.

Detailed Description
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The primary objective of this study is to conduct a single-arm pilot study in order to refine a Mindfulness-Based Intervention for the Opioid Use Disorder (OUD) treatment in primary care, called the Mindful Recovery OUD Care Continuum (M-ROCC). Study investigators will conduct qualitative interviews, assess opioid use, preliminary pre/post measures for participants participating in the pilot study. Additional aims of the pilot study is manual refinement and pilot testing assessment batteries to prepare for a multi-site RCT. The study will focus on demonstrating feasibility and acceptability of the M-ROCC continuum.

Official Title
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MINDFUL-OBOT Pilot: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment -- Pilot Study

Conditions
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Opioid-use Disorder, Anxiety, Depression, Stress Related Disorder

Intervention / Treatment
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* Behavioral: M-ROCC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Current CHA patient with a CHA primary care provider Diagnosis of opioid use disorder prescribed buprenorphine/naloxone Sufficient English fluency to understand procedures and questionnaires <90 days of complete abstinence from illicit opioids, cocaine, benzodiazepines, AND alcohol (excluding cannabis/nicotine) Ability to provide informed consent. Exclusion Criteria: Psychosis Mania Thought disorder Schizophrenia or Schizoaffective disorder Acute suicidality with plan Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) <24 OR the inability to complete consent quiz and baseline assessments. Current participation in another CHA research study Expected hospitalization in next 6 months, including second and third trimester pregnancy at screening.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: There will be no randomization for this pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M-ROCC<br>Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed with the clinical needs of OUD patients on buprenorphine and logistic needs of primary care OBOT clinicians in mind. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then ongoing mindful recovery support. | Behavioral: M-ROCC<br>* LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder. MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 8 weeks & 120 minutes/wk. MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for grads of LDM for 50 mins/wk. After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likelihood of recommending program to a friend | Percentage of participants who would recommend the program to a friend (score of 4 or 5 on a Likert scale (1-5)) | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of weekly sessions attended | Percentage of attendance out of 24 weekly group sessions during the 6 month study period. | Week 24 | 
| Anxiety PROMIS-SF 8a | The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Subjects are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). With use of the PROMIS Assessment Center Scoring Service, a T score is generated from subject responses. A sample item includes My worries overwhelmed me. | Week 24 | 
| Number of biochemically-confirmed illicit opioid abstinent weeks | Number of 2-week time periods with no self-reported illicit opioid use and biochemically-confirmed abstinence from illicit opioid use during a 24-week period. Urine toxicology will be administered every two weeks for 24 weeks and weekly self-report about illicit opioid use will be collected weekly. | Week 24 | 
| PROMIS-SF 8a (PROMIS-ASF) Pain Interference | The PROMIS Pain Interference instruments measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The Pain Interference short form is universal rather than disease-specific. It assesses pain interference over the past seven days. each question has five response options ranging in value from one to five (for pediatrics and parent proxy it is 0 to 4). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 6-item form, the lowest possible raw score is 6; the highest possible raw score is 30. A higher PROMIS T-score represents higher consequences of pain. | Week 24 |