One MORE for Chronic Pain in Latinos

April 16, 2024 updated by: Eric Garland, University of Utah

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity & Interference
Time Frame: 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.
Will be completed at baseline, week 2, and week 6.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute Pain
Time Frame: 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.
Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.
Acceptability
Time Frame: 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.
Will be completed immediately after the second of the two, 1-hour sessions of the One MORE intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Catastrophizing
Time Frame: Will be completed at baseline, week 2, and week 6.
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
Time Frame: Will be completed at baseline, week 2, and week 6.
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
Time Frame: Will be completed at baseline, week 2, and week 6.
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
Time Frame: Will be completed at baseline, week 2, and week 6.
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
Time Frame: Will be completed at baseline, week 2, and week 6.
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
Time Frame: Will be completed at baseline, week 2, and week 6.
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
Time Frame: Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.
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
Time Frame: Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.
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
Time Frame: Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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