NCT03798431

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Cambridge Health Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Opioid-use Disorder
• Anxiety
• Depression
• Stress Related Disorder

Interventions

Type	Name	Description
BEHAVIORAL	M-ROCC	1. 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. 2. 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. 3. 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.

Timeline

• Start date: 2018-12-11
• Primary completion: 2020-02-03
• Completion: 2020-02-03
• First posted: 2019-01-10
• Last updated: 2025-03-14

Locations

1 site across 1 country: United States