Mindfulness-Based Ecological Momentary Intervention for Opioid Use Disorder and Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArizona State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Mindfulness based smartphone app
BehavioralThe 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
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Evaluating the Feasibility and Acceptability of Mindful Journey PrototypeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Assessed at the end of the 8-week treatment period2
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.
Time frame
Assessed at the end of the 8-week treatment period3
Momentary ratings of acceptability of the ecological momentary intervention (momentary coaching)
Single item of perceived helpfulness
Time frame
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
Time frame
8-week treatment periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Arizona State University
Lead sponsor
Yale University
Collaborator
Source ClinicalTrials.gov