One MORE for Chronic Pain

Study Overview
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Brief Summary
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This study will be a single-site, two-arm randomized controlled trial conducted among chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually via a HIPAA compliant virtual meeting platform.

Official Title
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Examining the Efficacy of a Single Session Mindfulness Oriented Recovery Enhancement Intervention: One MORE

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: One MORE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men/women ≥18 years of age current chronic pain diagnosis reporting pain ≥3 on 0-10 scale Exclusion Criteria: unstable illness judged by clinician to interfere with study participation

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One MORE<br> | Behavioral: One MORE<br>* One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into four, 30-minute segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Mindful pain management will be the focus of the second segment and participants will be guided through a mindfulness of pain practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The third segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, and the fourth segment will focus on increasing the positive emotions that can attenuate pain with mindful savoring.<br>|
| No Intervention: Waitlist Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Catastrophizing | Change in pain catastrophizing from baseline through 3-month follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Change in pain intensity from baseline through 3-month follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain intensity. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | 
| Pain Interference | Change in pain interference from baseline through 3-month follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 20, with higher scores reflecting greater pain interference. | Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness