Virtual 1-Session Spanish "Empowered Relief" Group Intervention for Chronic Pain
- Conditions
- Chronic Pain
- Interventions
- Other: Usual CareBehavioral: Empowered Relief
- Registration Number
- NCT04546685
- Lead Sponsor
- Stanford University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Age 18+
- Chronic pain (at least 3 months or more)
- Spanish fluency
- Ability to adhere to and complete study procedures
- Cognitive impairment
- Previous participation in the Empowered Relief class
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Usual Care (waitlist) Usual Care Participants will continue their usual clinical care. 1-Session pain relief skills class (online Spanish Empowered Relief) 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 Measures
Name Time Method Treatment appraisal 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 At treatment At least 70% attendance for the registered Empowered Relief online class cohorts.
- Secondary Outcome Measures
Name Time Method Pain interference Post-treatment 1-month Pain interference: within-subject baseline to 1 month using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 8-item scale assesses pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" where higher scores represent a greater degree of pain interference.
Pain bothersomeness Post-treatment 1-month Pain bothersomeness: Within-subject baseline to 1 month the Pain Bothersomeness 1-item scale rated 0-10 assesses pain bothersomeness over the past 7 days. Higher scores represent a greater degree of pain bothersomeness.
Anxiety Post-treatment 1-month Anxiety: Within-subject baseline to 1 month the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 6-item scale assesses fearfulness, worry and nervousness in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of anxiety.
Pain intensity Post-treatment 1-month Pain intensity: within-subject baseline to 1 month using the Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity 1-item scale assesses average pain intensity for the past 7 days (0= "No pain" to 10= "Worst pain imaginable") where a higher score represents a greater degree of pain intensity.
Anger Post-treatment 1-month Anger: Within-subject baseline to 1 month the Patient Reported Outcomes Measurement Information System (PROMIS) Anger 5-item scale assesses anger over the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent a greater degree of anger.
Sleep disturbance Post-treatment 1-month Sleep disturbance: Within-subject baseline to 1 month using the Patient-reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 6-item scale assesses sleep quality over the past 7 days. Responses range from 1 to 5 where higher scores represent lower sleep quality.
Pain catastrophizing Post-treatment 1-month Pain Catastrophizing: Within-subject baseline to 1 month, the Pain Catastrophizing 13-item scale quantifies an individual's pain experience. Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Satisfaction with participation in social roles Post-treatment 1-month Satisfaction with participation in social roles: Within-subject baseline to 1 month the PROMIS Satisfaction with Participation in Social Roles 7-item scale assesses satisfaction with performing one's usual social roles and activities. Responses range from 1 = "Not at all" to 5 "Very much" where higher scores represent greater satisfaction.
Fatigue Post-treatment 1-month Fatigue: Within-subject baseline to 1 month the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 8-item scale assesses fatigue over the past 7 days. Responses range from 1 = "Not at all" and "Never" to 5 = "Very much" and "Always" where higher scores represent a greater degree of fatigue.
Depression Post-treatment 1-month Depression: Within-subject baseline to 1 month with the Patient Reported Outcomes Measurement Information System (PROMIS) Depression 6-item scale assesses negative mood in the past 7 days. Responses range from 1 = "Never" to 5 = "Always" where higher scores represent greater degree of depression.
Pain Self-Efficacy Post-treatment 1-month Pain Self-Efficacy: Within-subject baseline to 1 month with the Pain Self-Efficacy 2-item scale assessing confidence in functioning in the presence of pain. Responses range from 0 = "Not at all confident" to 6 = "Completely confident" where higher scores represent greater confidence in functioning.
Trial Locations
- Locations (1)
1070 Arastradero Rd
🇺🇸Palo Alto, California, United States