Chronic Pain, Opioid Use Disorder
Conditions
Keywords
mindfulness, opioid use disorder, chronic pain, mHealth, ecological momentary intervention
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 based upon ecological momentary assessments.
Interventions
BEHAVIORALMindfulness 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
Sponsors
Arizona State University
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dimensions of acceptability of the Mindful Journey lessons | 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) | 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) | 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 | 8-week treatment period | Percent of lessons completed |
| Completion rates for ecological momentary intervention (momentary coaching) | 8-week treatment period | Percent of ecological momentary interventions (momentary coaching) completed |
| Completion rates for momentary check-in surveys | 8-week treatment period | Percent of momentary check-in surveys completed |
Countries
United States
Outcome results
None listed