跳至主要内容
临床试验/NCT04546685
NCT04546685招募中不适用

Efficacy of a 1-Session Spanish "Empowered Relief" Videoconference-Delivered Group Intervention for Chronic Pain

Stanford University2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
2
主要终点
Treatment appraisal

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic pain (at least 3 months or more)
  • Spanish fluency
  • Ability to adhere to and complete study procedures

排除标准

  • Cognitive impairment
  • Previous participation in the Empowered Relief class

结局指标

主要结局

Treatment appraisal

时间窗: 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

时间窗: At treatment

At least 70% attendance for the registered Empowered Relief online class cohorts.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beth Darnall

Professor

Stanford University

研究点 (2)

Loading locations...

相似试验

Virtual 1-Session Spanish "Empowered Relief" Group... | 临床试验