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Completed

NCT Number: NCT05194241

One MORE for Chronic Pain

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One MORE

Behavioral

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 outcomes

  1. Pain Catastrophizing

    Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.

    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 outcomes

  1. Pain Intensity

    Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.

    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.

  2. Pain Interference

    Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.

    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.

Other outcomes

  1. Physical Function

    Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.

    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.

  2. Sleep

    Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.

    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.

  3. Depression

    Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.

    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.

  4. Anxiety

    Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.

    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.

  5. Prescription Pain Medication Misuse

    Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.

    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.

  6. Trait Mindfulness

    Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.

    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.

  7. Trait Self-Transcendence

    Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.

    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.

  8. Acute Pain

    Time frame: Will be completed immediately before and after the 2-hour, One MORE intervention.

    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.

  9. Decentering

    Time frame: Will be completed immediately before and after the 2-hour, One MORE intervention.

    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.

  10. Self-Transcendent State

    Time frame: Will be completed immediately before and after the 2-hour, One MORE intervention.

    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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2022
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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