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

NCT ID: NCT04546685

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2026-12-31

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).

Detailed Description

Poor access to behavioral pain care contributes substantially to chronic pain burden, particularly for underserved populations such as non-English speaking patients. Empowered Relief (ER) is an evidence-based 1-session (two hour) intervention that rapidly equips individuals with effective pain relief skills. Published evidence from four randomized trials suggest benefits in pain and symptom reduction up to 6 months later. While Spanish ER is being delivered by certified instructors in the U.S., Chile, Spain, Mexico and Puerto Rico, no study has examined patient perceptions and early treatment outcomes for Spanish ER. The investigators will conduct a randomized feasibility and short-term efficacy trial in 110 Spanish speaking patients with chronic pain. The investigators will compare online Spanish Empowered Relief® (ER) vs. Usual Care (UC) in patients with chronic pain of any type (>= 3 months). Participants will be 1:1 randomized to either ER or UC. The study primary endpoint is change in pain intensity or pain interference from baseline to 1 month follow-up (short-term efficacy). UC will be invited to cross over to ER after their 1-month survey (treatment appraisal and satisfaction data only will be collected after receipt of ER).

Aim 1: Test the feasibility of online group-based Spanish ER. Hypothesis 1a: Outcome 1, participant ratings will be >80% for the 7-item treatment appraisal/satisfaction measure administered immediately after completion of ER.

Hypothesis 1b: Outcome 2, ER attendance will be >70%.

Aim 2 (preliminary efficacy): Compare ER vs. UC for reducing multi-primary outcomes (pain intensity or pain interference) and secondary outcomes at 1 month post-treatment.

Hypothesis 2a: Outcome 3, ER will be superior to UC for reducing pain intensity or pain interference from baseline to 1 month follow-up (multi-primary study endpoint).

Hypothesis 2b: Outcome 4, ER will be superior to UC for reducing 4 priority secondary outcomes (sleep disturbance, pain catastrophizing, pain bothersomeness, and anxiety) from baseline to 1 month follow-up.

Hypothesis 2c: Outcome 5, ER will be superior to UC for reducing other secondary outcomes (satisfaction with social roles and responsibilities, anger, fatigue, pain self-efficacy, and depression) from baseline to 1 month follow-up. Patient outcomes will be longitudinally tracked at week 2 and 1 month after the intervention session for ER participants, and at week 2 and 1 month for the UC group.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Usual Care (waitlist)

Participants will continue their usual clinical care.

Group Type: OTHER

Usual Care

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Empowered Relief

Intervention Type: 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.

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Waitlist; 1-Session Pain Relief Skills Intervention

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SCAN Health Plan

UNKNOWN

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Beth Darnall

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beth Darnall, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

1070 Arastradero Rd

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lorena Contreras

Role: CONTACT

Phone: 650-497-6141

Email: spanishempoweredrelief@stanford.edu

Corrine A Jung, PhD

Role: CONTACT

Email: cejung@stanford.edu

Facility Contacts

Lorena Contreras

Role: primary

References

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.

Reference Type: DERIVED

PMID: 34505832 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34022930 (View on PubMed)

Other Identifiers

74942

Identifier Type: -

Identifier Source: org_study_id