Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT06316713

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

One MORE (Spanish Adaptation)

Study Details

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

Study ID

NCT06316713

Start date

Apr 8, 2024

Status verified date

Mar, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: One MORE (Spanish Adaptation)

no intervention: Waitlist Control

Interventions

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.

Primary outcome measure

  • Pain Intensity & Interference [ Time Frame: Will be completed at baseline, week 2, and week 6. ]

Central Contacts and Locations

Central contacts

Eric Garland, PhD

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

Carter Minnick, BA

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

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Eric Garland, PhD

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

More Information

Sponsor

University of Utah

Last update posted

Apr 17, 2024

Last verified

Mar, 2024

Keywords

  • Mindfulness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2024-04-17.