Virtual 1-Session Spanish "Empowered Relief" Group Intervention for Chronic Pain

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT04546685
Status
Recruiting
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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Usual Care — OTHER
    Participants who are randomized to the Usual Care group (waitlist for cross-over to ER) will be instructed to continue with their normal pain care. They will receive only study surveys (baseline, 2 weeks, and 1 month). Upon completion of the 1-month study, UC participants will be invited to cross-over and receive ER. Post-class treatment appraisal/satisfaction data only will be collected.
  • Empowered Relief — BEHAVIORAL
    The participants will attend an online Spanish Empowered Relief class. The two hour group session is delivered by a certified instructor and includes pain neuroscience education, 3 core pain management skills, experiential exercises, completion of a personalized plan for empowered relief. Participants download a Spanish binaural relaxation audio file for daily use.

Study Details

Empowered Relief (ER) is a 1-session pain relief skills intervention that is delivered in-person or online by certified clinicians to groups of patients with acute or chronic pain. Prior work in has shown ER efficacy for reducing chronic pain, pain-related distress, and other symptoms 6 months post-treatment. The purpose of this randomized trial is to conduct the first feasibility and early efficacy test of online Spanish ER delivered to Spanish-speaking adult patients with chronic pain. Participants will be followed for 1 month via 3 follow-up surveys (immediately after treatment, 2 weeks and 1 month post-treatment).

Key Dates

Start date
Jun 12, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: Usual Care (waitlist)
    Participants will continue their usual clinical care.
  • Experimental: 1-Session pain relief skills class (online Spanish Empowered Relief)
    Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to a group of patients by a Spanish-fluent certified instructor using a standardized treatment manual and electronic slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use.

Primary Outcome Measure

Treatment appraisal [ Time Frame: Immediately post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
1070 Arastradero RdPalo AltoCalifornia94304-1334
Lorena Contreras
[email protected]
Beth Darnall, PhD (PRINCIPAL_INVESTIGATOR)

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