One MORE for Chronic Pain in Latinos

NCT06316713 | Recruiting

• 1 other identifier: IRB_00166637
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acute Pain

  Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.

• Acceptability

  Will be completed immediately after the second of the two, 1-hour sessions of the One MORE intervention.

Other Outcomes (9)

• Pain Catastrophizing

  Will be completed at baseline, week 2, and week 6.

• Well-Being

  Will be completed at baseline, week 2, and week 6.

• Depression

  Will be completed at baseline, week 2, and week 6.

Study Arms (2)

One MORE (Spanish Adaptation)

EXPERIMENTAL

Behavioral: One MORE (Spanish Adaptation)

Waitlist Control

NO INTERVENTION

Interventions

One MORE (Spanish Adaptation) BEHAVIORAL

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.

One MORE (Spanish Adaptation)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Eric Garland, PhD

CONTACT

801-581-3826; eric.garland@socwk.utah.edu

Carter Minnick, BA

CONTACT

804-912-6338; carter.minnick@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 18, 2024
• Study Start: April 8, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-03

Locations

US (1)