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

NCT04546685 | Recruiting

• 1 other identifier: 74942
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Treatment appraisal

  7 items assess treatment appraisal/satisfaction using 7-point scales (0-6) where higher ratings represent greater appraisal/satisfaction with the treatment. The investigators hypothesize \>=80% ratings for treatment appraisal/satisfaction rated immediately post-treatment.

  Immediately post-treatment

• Class Attendance

  At least 70% attendance for the registered Empowered Relief online class cohorts.

  At treatment

Secondary Outcomes (11)

• Pain intensity

  Post-treatment 1-month

• Pain interference

  Post-treatment 1-month

• Sleep disturbance

  Post-treatment 1-month

• Pain catastrophizing

  Post-treatment 1-month

• Pain bothersomeness

  Post-treatment 1-month

Study Arms (2)

Usual Care (waitlist)

OTHER

Participants will continue their usual clinical care.

Other: Usual Care

1-Session pain relief skills class (online Spanish Empowered Relief)

EXPERIMENTAL

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.

Behavioral: Empowered Relief

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.

Also known as: Waitlist

Usual Care (waitlist)

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.

Also known as: 1-Session Pain Relief Skills Intervention

1-Session pain relief skills class (online Spanish Empowered Relief)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Chronic pain (at least 3 months or more)
• Spanish fluency
• Ability to adhere to and complete study procedures

You may not qualify if:

• Cognitive impairment
• Previous participation in the Empowered Relief class

Sponsors & Collaborators

• Stanford University: lead
• SCAN Health Plan: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

1070 Arastradero Rd

Palo Alto, California, 94304-1334, United States

RECRUITING

Related Publications (2)

• Ziadni MS, Gonzalez-Castro L, Anderson S, Krishnamurthy P, Darnall BD. Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic. J Med Internet Res. 2021 Sep 10;23(9):e29672. doi: 10.2196/29672.

  PMID: 34505832 DERIVED

• Ziadni MS, Anderson SR, Gonzalez-Castro L, Darnall BD. Comparative efficacy of a single-session "Empowered Relief" videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial. Trials. 2021 May 22;22(1):358. doi: 10.1186/s13063-021-05303-8.

  PMID: 34022930 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Beth Darnall, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorena Contreras

CONTACT

650-497-6141; spanishempoweredrelief@stanford.edu

Corrine A Jung, PhD

CONTACT

cejung@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 14, 2020
• Study Start: June 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)