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NCT Number: NCT06947122

Mindfulness-Based Ecological Momentary Intervention for Opioid Use Disorder and Chronic Pain

The goal of this clinical trial is to evaluate whether a smartphone app-based ecological momentary intervention called Mindful Journey, which teaches mindfulness skills, can support adults in recovery from both opioid use disorder and chronic pain. The primary objective of this pilot study is to assess the feasibility and acceptability of Mindful Journey in this population.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University, Phoenix, Arizona, United States

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About this study

There is a paucity of interventions for co-occurring opioid use disorder and chronic pain. Difficulty with emotion regulation is a key shared vulnerability factor underlying both conditions. Mindfulness-Based Interventions (MBIs) are a promising intervention approach, as they target core skills that can improve emotion regulation. However, research on MBIs for co-morbid opioid use disorder and chronic pain is limited. Existing MBIs are also limited by not providing adequate support "in the moment" when individuals are in high-risk situations. A responsive, momentary MBI for co-occurring opioid use disorder and chronic pain may be highly promising, but has yet to be established. In the present study, we will be evaluating a smartphone app-based ecological momentary intervention, called Mindful Journey, for individuals with opioid use disorder and chronic pain. The core feature of the app is training in mindful acceptance and savoring skills via momentary "just-in-time" delivery of brief video-based exercises based upon ecological momentary assessments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • fluent in English
  • enrollment in medication-assisted treatment for opioid use disorder
  • report at least bothersome chronic pain, as indicated by Graded Chronic Pain Scale-Revised
  • has a smartphone.

Exclusion criteria

  • self-reporting of chronic malignant pain (e.g., cancer) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus, and sarcoidosis)
  • 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.

Treatment and study plan

Mindfulness based smartphone app

Behavioral

The Mindful Journey intervention includes (1) 14 foundational modules/lessons, (2) brief check-in surveys (3 times/day) via the app, (3) app-guided momentary mindfulness coaching (max 3 times/day), and (4) brief phone-based check-in from a trained staff member, on a weekly basis. Occurring for approximately 8 weeks following enrollment visit

Other names: Mindful Journey

Primary outcomes

  1. Dimensions of acceptability of the Mindful Journey lessons

    Time frame: Assessed at the end of the 8-week treatment period

    Single-items measuring ratings of acceptability dimensions for the lessons, including usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills. Scores for each item range from 1 to 5, with higher scores indicating better acceptability.

  2. Dimensions of acceptability of the ecological momentary intervention (momentary coaching)

    Time frame: Assessed at the end of the 8-week treatment period

    Single-items measuring ratings of acceptability dimensions for ecological momentary intervention (momentary coaching), including usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills. Scores for each item range from 1 to 5, with higher scores indicating better acceptability.

  3. Momentary ratings of acceptability of the ecological momentary intervention (momentary coaching)

    Time frame: Administered immediately after participants receive each ecological momentary intervention (momentary coaching)

    Single item of perceived helpfulness

  4. Completion rates for the lessons on the Mindful Journey

    Time frame: 8-week treatment period

    Percent of lessons completed

  5. Completion rates for ecological momentary intervention (momentary coaching)

    Time frame: 8-week treatment period

    Percent of ecological momentary interventions (momentary coaching) completed

  6. Completion rates for momentary check-in surveys

    Time frame: 8-week treatment period

    Percent of momentary check-in surveys completed

Study contacts

Contact information is provided by the study sponsor or research team.

Chung Jung Mun, Ph.D

CONTACT

[email protected]

602-496-0665

Corey Roos, Ph.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Yale University

Registry information

Official study title

Mindfulness-Based Ecological Momentary Intervention for Co-Occurring Opioid Use Disorder and Chronic Pain: A Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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