Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04546685
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2020-09-04
Brief Title:
Virtual 1-Session Spanish Empowered Relief Group Intervention for Chronic Pain
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Efficacy of a 1-Session Spanish Empowered Relief Videoconference-Delivered Group Intervention for Chronic Pain
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 11 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 appraisalsatisfaction 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
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 appraisalsatisfaction 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None