Clinical trial NCT06316713: One MORE for Chronic Pain in Latinos
Official title: Spanish Language Adaptation of One MORE for Chronic Pain in Latinos
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Mindfulness
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity & Interference
timeFrame: Will be completed at baseline, week 2, and week 6.
Secondary outcomes:
measure: Acute Pain
timeFrame: Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.
measure: Acceptability
timeFrame: Will be completed immediately after the second of the two, 1-hour sessions of the One MORE intervention.
Other outcomes:
measure: Pain Catastrophizing
timeFrame: Will be completed at baseline, week 2, and week 6.
measure: Well-Being
timeFrame: Will be completed at baseline, week 2, and week 6.
measure: Depression
timeFrame: Will be completed at baseline, week 2, and week 6.
measure: Anxiety
timeFrame: Will be completed at baseline, week 2, and week 6.
measure: Mindful Reappraisal of Pain Sensations
timeFrame: Will be completed at baseline, week 2, and week 6.
measure: Trait Self-Transcendence
timeFrame: Will be completed at baseline, week 2, and week 6.
measure: Decentering
timeFrame: Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.
measure: State Self-Transcendence
timeFrame: Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.
measure: State Anxiety
timeFrame: Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: