One MORE for Chronic Pain in Latinos

Spanish Language Adaptation of One MORE for Chronic Pain in Latinos

This study will be a single-site, two-arm randomized controlled trial conducted among Spanish-speaking 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 either in-person or via a HIPAA compliant virtual meeting platform.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: One MORE (Spanish Adaptation)

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Garland, PhD; Phone Number: 801-581-3826; Email: eric.garland@socwk.utah.edu
• Study Contact Backup: Name: Carter Minnick, BA; Phone Number: 804-912-6338; Email: carter.minnick@utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Eric Garland, PhD; Phone Number: 801-581-3826; Email: eric.garland@socwk.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Spanish-speaking
• Age 18+
• Diagnosed with a chronic pain condition
• Average pain in the previous week > or = 3
• Willingness to participate in study interventions and assessments.

Exclusion Criteria:

• Non Spanish-speaking
• Score of 10 or greater ('high risk') on the suicidality subsection of the MINI
• Psychotic episode within the last 12 months as deemed by the corresponding subsection of the MINI
• Presence of clinically unstable illness judged to interfere with treatment or study procedures
• Unable or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier)
• Communication or cognitive impairment that limits participation in treatment or study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control
Experimental: One MORE (Spanish Adaptation)	Behavioral: One MORE (Spanish Adaptation); One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into two, 1-hour 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. Participants will also be guided through a mindful pain management practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The second segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, as well as learning to 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 Intensity & Interference	Change in pain intensity and interference from baseline through 6-week follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 30, with higher scores reflecting greater pain intensity/interference.	Will be completed at baseline, week 2, and week 6.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Pain	Change in acute pain will be measured with two individual items ("How much pain are you in, right now?", and "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 each of the two, 1-hour sessions of the One MORE intervention.
Acceptability	Acceptability will be measured with two individual items ("How acceptable did you find the strategies for managing your pain?") and ("How likely would you be to recommend this therapy to someone else dealing with chronic pain?") Scores range from 0 to 10, with higher scores indicating greater program acceptability.	Will be completed immediately after the second of the two, 1-hour sessions of the One MORE intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing	Change in pain catastrophizing from baseline through 6-week follow-up will be assessed with the Pain Catastrophizing Scale (4 question version). Scores range from 0 to 20, with higher scores reflecting greater pain catastrophizing.	Will be completed at baseline, week 2, and week 6.
Well-Being	Change in well-being from baseline through 6-week follow-up will be assessed with the World Health Organization Well-Being Scale (5 question version). Scores range from 0 to 25, with higher scores indicating greater well-being.	Will be completed at baseline, week 2, and week 6.
Depression	Change in depression from baseline through 6-week 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 week 6.
Anxiety	Change in anxiety from baseline through 6-week 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 week 6.
Mindful Reappraisal of Pain Sensations	Change in Mindful Reappraisal of Pain Sensations from baseline through 6-week follow-up will be assessed with the Mindful Reappraisal of Pain Sensations Scale. Scores range from 0 to 54, with higher scores indicating greater mindful reappraisal of pain sensations.	Will be completed at baseline, week 2, and week 6.
Trait Self-Transcendence	Change in trait self-transcendence from baseline through 6-week 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 week 6.
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 each of the two, 1-hour sessions of the One MORE intervention.
State Self-Transcendence	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 each of the two, 1-hour sessions of the One MORE intervention.
State Anxiety	Change in state anxiety will be measured with an individual item ("How anxious are you, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute anxiety.	Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: IRB_00166637

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