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

NCT ID: NCT06947122

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-02
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Chronic Pain; Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Evaluating the Feasibility and Acceptability of Mindful Journey Prototype

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.

Group Type: EXPERIMENTAL

Mindfulness based smartphone app

Intervention Type: 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

Interventions

Mindfulness based smartphone app

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Mindful Journey

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Chung Jung Mun

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arizona State University

Phoenix, Arizona, United States

Site Status: RECRUITING

Arizona State University Downtown Phoenix Campus

Phoenix, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chung Jung Mun, Ph.D

Role: CONTACT

chungjung.mun@asu.edu

602-496-0665

Corey Roos, Ph.D

Role: CONTACT

corey.roos@yale.edu

Facility Contacts

Chung Jung Mun, Ph.D

Role: primary

ChungJung.Mun@asu.edu

6024960665

Chung Jung Mun, Ph.D.

Role: primary

cjmun@asu.edu

602-496-0809

References

Wong SYS, Chan JYC, Zhang D, Lee EKP, Tsoi KKF. The safety of mindfulness-based interventions: a systematic review of randomized controlled trials. Mindfulness (N Y). 2018;9:1344-1357.

Reference Type: BACKGROUND

Spijkerman MP, Pots WT, Bohlmeijer ET. Effectiveness of online mindfulness-based interventions in improving mental health: A review and meta-analysis of randomised controlled trials. Clin Psychol Rev. 2016 Apr;45:102-14. doi: 10.1016/j.cpr.2016.03.009. Epub 2016 Apr 1.

Reference Type: BACKGROUND

PMID: 27111302 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 7551619 (View on PubMed)

Flannery BA, Volpicelli JR, Pettinati HM. Psychometric properties of the Penn Alcohol Craving Scale. Alcohol Clin Exp Res. 1999 Aug;23(8):1289-95.

Reference Type: BACKGROUND

PMID: 10470970 (View on PubMed)

Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

Reference Type: BACKGROUND

PMID: 8080219 (View on PubMed)

Von Korff M, DeBar LL, Krebs EE, Kerns RD, Deyo RA, Keefe FJ. Graded chronic pain scale revised: mild, bothersome, and high-impact chronic pain. Pain. 2020 Mar;161(3):651-661. doi: 10.1097/j.pain.0000000000001758.

Reference Type: BACKGROUND

PMID: 31764390 (View on PubMed)

Other Identifiers

STUDY00019109

Identifier Type: -

Identifier Source: org_study_id