One MORE for Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One MORE
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Mindfulness
Eligibility Criteria
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
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
One MORE
Waitlist Control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05194241
Brief Title
One MORE for Chronic Pain
Official Title
Examining the Efficacy of a Single Session Mindfulness Oriented Recovery Enhancement Intervention: One MORE
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
November 27, 2022 (Actual)
Study Completion Date
November 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Mindfulness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One MORE
Arm Type
Experimental
Arm Title
Waitlist Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
One MORE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Catastrophizing
Description
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.
Time Frame
Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Title
Pain Interference
Description
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.
Time Frame
Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Other Pre-specified Outcome Measures:
Title
Physical Function
Description
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.
Time Frame
Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Title
Sleep
Description
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.
Time Frame
Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Title
Depression
Description
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.
Time Frame
Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Title
Anxiety
Description
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.
Time Frame
Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Title
Prescription Pain Medication Misuse
Description
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.
Time Frame
Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Title
Trait Mindfulness
Description
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.
Time Frame
Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Title
Trait Self-Transcendence
Description
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.
Time Frame
Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Title
Acute Pain
Description
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.
Time Frame
Will be completed immediately before and after the 2-hour, One MORE intervention.
Title
Decentering
Description
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.
Time Frame
Will be completed immediately before and after the 2-hour, One MORE intervention.
Title
Self-Transcendent State
Description
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.
Time Frame
Will be completed immediately before and after the 2-hour, One MORE intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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