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

NCT06947122 | Recruiting

• 1 other identifier: STUDY00019109
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain; Opioid Use Disorder

Keywords

mindfulness; opioid use disorder; chronic pain; mHealth; ecological momentary intervention

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Evaluating the Feasibility and Acceptability of Mindful Journey Prototype

EXPERIMENTAL

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

Interventions

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

Also known as: Mindful Journey

Evaluating the Feasibility and Acceptability of Mindful Journey Prototype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead
• Yale University: collaborator

Study Sites (2)

Arizona State University

Phoenix, Arizona, 85004, United States

RECRUITING

Arizona State University Downtown Phoenix Campus

Phoenix, Arizona, 85023, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 27111302 BACKGROUND

• 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.

  PMID: 7551619 BACKGROUND

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

  PMID: 10470970 BACKGROUND

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

  PMID: 8080219 BACKGROUND

• 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.

  PMID: 31764390 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Chung Jung Mun, Ph.D

CONTACT

602-496-0665; chungjung.mun@asu.edu

Corey Roos, Ph.D

CONTACT

corey.roos@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)