Treating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention

Study Overview
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Brief Summary
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This pilot RCT will examine the preliminary efficacy of a telehealth version of Mindfulness-Oriented Recovery Enhancement (MORE) enriched with a smartphone-based just-in-time adaptive intervention (JITAI) for patients with chronic pain on long-term opioid therapy.

Official Title
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Reating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: MORE+JITAI
* Behavioral: Supporive Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current chronic pain diagnosis determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4) Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days Willingness to participate in study interventions and assessments Exclusion Criteria: Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention Active suicidality, schizophrenia, psychotic disorder Presence of clinically unstable systemic illness judged to interfere with treatment No access to internet (which will prevent telehealth-based treatment)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Oriented Recovery Enhancement+JITAI<br>Participants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks. | Behavioral: MORE+JITAI<br>* Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse. JITAI involves stress-triggered reminders to practice mindfulness skills.<br>|
| Active Comparator: Supportive Psychotherapy<br>Participants will attend a telehealth supportive psychotherapy group weekly for eight weeks. | Behavioral: Supporive Psychotherapy<br>* A supportive psychotherapy group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in momentary craving | Craving measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more craving) | Baseline through 1-month follow-up | 
| Change in momentary pain: numeric rating scale | Pain measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more pain) | Baseline through 1-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in momentary positive affect | Positive affect measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more positive affect) | Baseline through 1-month follow-up | 
| Change in momentary stress | Stress measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more stress) | Baseline through 1-month follow-up | 
| Change in heart rate variability | Changes in heart rate variability (HRV) measured via ambulatory HRV assessment | Baseline through 1-month follow-up |