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

Arizona State University (ASU)

Status: Enrolling

Conditions: Opioid Use Disorder; Chronic Pain

Treatments: Behavioral: Mindfulness based smartphone app

Study type: Interventional

Funder types: Other

Identifiers

NCT06947122

STUDY00019109

Details and patient eligibility

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Evaluating the Feasibility and Acceptability of Mindful Journey Prototype

Experimental group

Description:

In 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.

Treatment:

Behavioral: Mindfulness based smartphone app