One MORE for Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194241
• Other study ID #: 00146987
• Status: Completed
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: November 27, 2022

Study information

• Verified date: March 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 27, 2022
• Est. primary completion date: November 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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	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.
Secondary	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.