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Chronic PainNCT06947122

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

A study testing Mindfulness based smartphone app in people with Chronic Pain and Opioid Use Disorder, run by Arizona State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain, Opioid Use Disorder
What is being tested?
Mindfulness based smartphone app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
10 Feb 2026to 2 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Arizona State University

    Phoenix, Arizona, 85004

  • Arizona State University Downtown Phoenix Campus

    Phoenix, Arizona, 85023

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Mindfulness based smartphone app
Keywords
mindfulness, opioid use disorder, chronic pain, mHealth, ecological momentary intervention
Medical subject headings
Chronic Pain, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness based smartphone appBehavioural

    Also called Mindful Journey

    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

Study groups in NCT06947122
Study groupRoleWhat they receive
Evaluating the Feasibility and Acceptability of Mindful Journey PrototypeExperimentalIn 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.
Receives: Behavioral: Mindfulness based smartphone app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessed at the end of the 8-week treatment period

  2. 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.

    Measured: Assessed at the end of the 8-week treatment period

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

    Single item of perceived helpfulness

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

  4. Completion rates for the lessons on the Mindful Journey

    Percent of lessons completed

    Measured: 8-week treatment period

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

    Percent of ecological momentary interventions (momentary coaching) completed

    Measured: 8-week treatment period

  6. Completion rates for momentary check-in surveys

    Percent of momentary check-in surveys completed

    Measured: 8-week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2025
  2. Study start10 Feb 2026
  3. Primary completion14 May 2026
  4. Study completion2 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06947122
Sponsor's protocol ID
STUDY00019109
Status last verified
Sep 2026
First submitted
21 Apr 2025
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 27111302

  • 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.

    PubMed 7551619

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

    PubMed 10470970

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

    PubMed 8080219

  • 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.

    PubMed 31764390

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness based smartphone app in people with Chronic Pain and Opioid Use Disorder, run by Arizona State University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dimensions of acceptability of the Mindful Journey lessons (time frame: Assessed at the end of the 8-week treatment period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06947122, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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