One MORE for Chronic Pain in Latinos

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Behavioral: One MORE (Spanish Adaptation)

• Registration Number: NCT06316713
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-18
• Study Start: 2024-04-08
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
One MORE (Spanish Adaptation)	One MORE (Spanish Adaptation)	-

Primary Outcome Measures

Name	Time	Method
Pain Intensity & Interference	Will be completed at baseline, week 2, and week 6.	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability	Will be completed immediately after the second of the two, 1-hour sessions of the One MORE intervention.	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.
Acute Pain	Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.	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.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States