Clinical trial NCT06947122: Mindfulness-Based Ecological Momentary Intervention for Opioid Use Disorder and Chronic Pain
Official title: Mindfulness-Based Ecological Momentary Intervention for Co-Occurring Opioid Use Disorder and Chronic Pain: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Opioid Use Disorder
Keywords: mindfulness
opioid use disorder
chronic pain
mHealth
ecological momentary intervention
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2025-04-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 when individuals report elevations in challenging emotional states (e.g., craving, stress, and pain) and/or decreases in positive affect based upon ecological momentary assessments.

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.

Primary outcomes:
measure: Dimensions of acceptability of the Mindful Journey lessons
timeFrame: Assessed at the end of the 8-week treatment period
measure: Dimensions of acceptability of the ecological momentary intervention (momentary coaching)
timeFrame: Assessed at the end of the 8-week treatment period
measure: Momentary ratings of acceptability of the ecological momentary intervention (momentary coaching)
timeFrame: Administered immediately after participants receive each ecological momentary intervention (momentary coaching)
measure: Completion rates for the lessons on the Mindful Journey
timeFrame: 8-week treatment period
measure: Completion rates for ecological momentary intervention (momentary coaching)
timeFrame: 8-week treatment period
measure: Completion rates for momentary check-in surveys
timeFrame: 8-week treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
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