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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Opioid Use Disorder
• Intervention / Treatment: Behavioral: Mindfulness based smartphone app

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chung Jung Mun, Ph.D; Phone Number: 602-496-0665; Email: chungjung.mun@asu.edu
• Study Contact Backup: Name: Corey Roos, Ph.D; Email: corey.roos@yale.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Arizona State University
      • Contact: Chung Jung Mun, Ph.D; Phone Number: 6024960665; Email: ChungJung.Mun@asu.edu
    • Phoenix, Arizona, United States, 85023
      • Recruiting
      • Arizona State University Downtown Phoenix Campus
      • Principal Investigator: Chung Jung Mun, Ph.D.
      • Contact: Chung Jung Mun, Ph.D.; Phone Number: 602-496-0809; Email: cjmun@asu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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; Other Names: Mindful Journey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dimensions of acceptability of the Mindful Journey lessons	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.	Assessed at the end of the 8-week treatment period
Dimensions of acceptability of the ecological momentary intervention (momentary coaching)	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.	Assessed at the end of the 8-week treatment period
Momentary ratings of acceptability of the ecological momentary intervention (momentary coaching)	Single item of perceived helpfulness	Administered immediately after participants receive each ecological momentary intervention (momentary coaching)
Completion rates for the lessons on the Mindful Journey	Percent of lessons completed	8-week treatment period
Completion rates for ecological momentary intervention (momentary coaching)	Percent of ecological momentary interventions (momentary coaching) completed	8-week treatment period
Completion rates for momentary check-in surveys	Percent of momentary check-in surveys completed	8-week treatment period

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Yale University

Publications and helpful links

General Publications

• Flannery BA, Volpicelli JR, Pettinati HM. Psychometric properties of the Penn Alcohol Craving Scale. Alcohol Clin Exp Res. 1999 Aug;23(8):1289-95.
• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
• 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.
• Snaith RP, Hamilton M, Morley S, Humayan A, Hargreaves D, Trigwell P. A scale for the assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. Br J Psychiatry. 1995 Jul;167(1):99-103. doi: 10.1192/bjp.167.1.99.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; mindfulness; mHealth; opioid use disorder; ecological momentary intervention
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Opioid-Related Disorders; Chronic Pain
• Other Study ID Numbers: STUDY00019109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared because the primary goal of this pilot study is to assess feasibility and acceptability, not to generate generalizable efficacy data suitable for secondary analyses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No