One MORE for Chronic Pain

NCT05194241 | Completed

• 1 other identifier: 00146987
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain Intensity

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

• Pain Interference

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

Other Outcomes (10)

• Physical Function

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

• Sleep

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

• Depression

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

Study Arms (2)

One MORE

EXPERIMENTAL

Behavioral: One MORE

Waitlist Control

NO INTERVENTION

Interventions

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.

One MORE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men/women ≥18 years of age
• current chronic pain diagnosis
• reporting pain ≥3 on 0-10 scale

You may not qualify if:

• unstable illness judged by clinician to interfere with study participation

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Hanley AW, Lingard A, Garland EL. A Single-Session, 2-Hour Version of Mindfulness-Oriented Recovery Enhancement (One MORE) Improves Chronic Pain Patients' Pain-Related Outcomes Through 3-Month Follow-Up in a Randomized Controlled Trial. J Integr Complement Med. 2024 Sep;30(9):869-877. doi: 10.1089/jicm.2023.0501. Epub 2024 Apr 8.

  PMID: 38588552 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: January 18, 2022
• Study Start: November 18, 2021
• Primary Completion: November 27, 2022
• Study Completion: November 27, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

US (1)