NCT06947122 · Arizona State University
Mindfulness-Based Ecological Momentary Intervention for Opioid Use Disorder and Chronic Pain
What this study is about
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.
View original scientific description
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.
Interventions
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
Primary outcome measures
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.
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.
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
Completion rates for the lessons on the Mindful Journey
Time frame: 8-week treatment period
Percent of lessons completed
Completion rates for ecological momentary intervention (momentary coaching)
Time frame: 8-week treatment period
Percent of ecological momentary interventions (momentary coaching) completed
Completion rates for momentary check-in surveys
Time frame: 8-week treatment period
Percent of momentary check-in surveys completed
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Phoenix, Arizona
Collaborators
Yale University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations