Recruiting

Empowered Relief

Sponsor:

Stanford University

Code:

NCT04546685

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Usual Care

Empowered Relief

Study Details

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

Study ID

NCT04546685

Start date

Jun 12, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Cognitive impairment
2. Previous participation in the Empowered Relief class

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Usual Care

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

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.

Primary outcome measure

  • Treatment appraisal [ Time Frame: Immediately post-treatment ]
  • Class Attendance [ Time Frame: At treatment ]

Central Contacts and Locations

Central contacts

Locations

1070 Arastradero Rd

Recruiting

Palo Alto, California, United States, 94304-1334

Contacts

Principal Investigator:

Beth Darnall, PhD

More Information

Sponsor

Stanford University

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-12-22.