One MORE for Chronic Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: One MORE

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Hanley, PhD; Phone Number: 801-213-4191; Email: adam.hanley@utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control
Experimental: One MORE	Behavioral: One MORE; 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function	Change in physical function from baseline through 3-month follow-up will be assessed with the PROMIS Physical Functioning Short Form. Scores range from 6 to 30, with higher scores reflecting greater physical function.	Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Sleep	Change in sleep from baseline through 3-month follow-up will be assessed with the PROMIS Sleep Disturbance Short Form. Scores range from 6 to 30, with higher scores reflecting worse sleep.	Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Depression	Change in depression from baseline through 3-month follow-up will be assessed with the Patient Health Questionnaire-2. Scores range from 0 to 6, with higher scores reflecting greater depression.	Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Anxiety	Change in anxiety from baseline through 3-month follow-up will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety.	Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Prescription Pain Medication Misuse	Change in prescription pain medication misuse from baseline through 3-month follow-up will be assessed with the PROMIS Prescription Pain Medication Misuse Short Form. Scores range from 7 to 35, with higher scores reflecting greater medication misuse.	Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Trait Mindfulness	Change in trait mindfulness from baseline through 3-month follow-up will be assessed with the Toronto Mindfulness Scale - Trait Version. Scores range from 0 to 52, with higher scores reflecting greater trait mindfulness.	Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Trait Self-Transcendence	Change in trait self-transcendence from baseline through 3-month follow-up will be assessed with the Nondual Awareness Dimensional Assessment - Trait Version. Scores range from 0 to 52, with higher scores reflecting greater trait self-transcendence.	Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Acute Pain	Change in acute pain will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain.	Will be completed immediately before and after the 2-hour, One MORE intervention.
Decentering	Change in decentering will be measured with the state version of the Metacognitive Processes of Decentering scale. Scores range from 0 to 10, with higher scores reflecting greater decentering.	Will be completed immediately before and after the 2-hour, One MORE intervention.
Self-Transcendent State	Change in self-transcendent state will be measured with the Nondual Awareness Dimensional Assessment - State Version. Scores range from 0 to 10, with higher scores reflecting greater self-transcendence.	Will be completed immediately before and after the 2-hour, One MORE intervention.

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): November 27, 2022
• Study Completion (Actual): November 27, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 00146987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No