Efficacy of a 1-Session Spanish "Empowered Relief" Videoconference-Delivered Group Intervention for Chronic Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Treatment appraisal
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic pain (at least 3 months or more)
- •Spanish fluency
- •Ability to adhere to and complete study procedures
Exclusion Criteria
- •Cognitive impairment
- •Previous participation in the Empowered Relief class
Arms & Interventions
Usual Care (waitlist)
Participants will continue their usual clinical care.
Intervention: Usual Care (Other)
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.
Intervention: Empowered Relief (Behavioral)
Outcomes
Primary Outcomes
Treatment appraisal
Time Frame: Immediately post-treatment
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.
Class Attendance
Time Frame: At treatment
At least 70% attendance for the registered Empowered Relief online class cohorts.
Secondary Outcomes
- Pain interference(Post-treatment 1-month)
- Pain bothersomeness(Post-treatment 1-month)
- Anxiety(Post-treatment 1-month)
- Pain intensity(Post-treatment 1-month)
- Anger(Post-treatment 1-month)
- Sleep disturbance(Post-treatment 1-month)
- Pain catastrophizing(Post-treatment 1-month)
- Satisfaction with participation in social roles(Post-treatment 1-month)
- Fatigue(Post-treatment 1-month)
- Depression(Post-treatment 1-month)
- Pain Self-Efficacy(Post-treatment 1-month)
Investigators
Beth Darnall
Professor
Stanford University