Clinical trial NCT04546685: Virtual 1-Session Spanish "Empowered Relief" Group Intervention for Chronic Pain
Official title: Efficacy of a 1-Session Spanish "Empowered Relief" Videoconference-Delivered Group Intervention for Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: SCAN Health Plan
name: The Cleveland Clinic
First posted: 2020-09-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment appraisal
timeFrame: Immediately post-treatment
measure: Class Attendance
timeFrame: At treatment
Secondary outcomes:
measure: Pain intensity
timeFrame: Post-treatment 1-month
measure: Pain interference
timeFrame: Post-treatment 1-month
measure: Sleep disturbance
timeFrame: Post-treatment 1-month
measure: Pain catastrophizing
timeFrame: Post-treatment 1-month
measure: Pain bothersomeness
timeFrame: Post-treatment 1-month
measure: Anxiety
timeFrame: Post-treatment 1-month
measure: Satisfaction with participation in social roles
timeFrame: Post-treatment 1-month
measure: Anger
timeFrame: Post-treatment 1-month
measure: Fatigue
timeFrame: Post-treatment 1-month
measure: Depression
timeFrame: Post-treatment 1-month
measure: Pain Self-Efficacy
timeFrame: Post-treatment 1-month
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: 1070 Arastradero Rd
state: California
Study officials:
affiliation: Stanford University
name: Beth Darnall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.