Comparative Effectiveness of Online Cognitive Behavioral Therapy vs. An Online Single-Session Pain Relief Skills Class for Chronic Pain - The PROGRESS Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,650
- 试验地点
- 10
- 主要终点
- Pain Intensity
研究概览
简要总结
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-CBT; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief; two hours total treatment time).
详细描述
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief). The investigators aim to understand for patients which treatment works best.
Online evidence-based behavioral treatment for pain will greatly expand access to patients across the U.S. living with diverse chronic pain conditions. Results from this study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care.
This study will provide a low-cost, relatively low-risk, widely available and feasible protocol that directly addresses the needs of millions of community-based outpatients and their physicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants and research staff will know arm assignment. Co-investigators, project statisticians, and the protocol director at each study site will remain blinded until final assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age or older of either sex (and all genders).
- •Chronic pain (pain that occurs on at least half of the days of 3 months or more).
- •Past-month average pain intensity score of at least 3/
- •Ability to adhere to and complete study protocols.
排除标准
- •Inability to provide informed consent.
- •Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment.
- •Active suicidality documented in medical records.
- •Study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort.
- •Receipt of either study treatment in the past 3 months.
研究组 & 干预措施
Young Adult (18-23) Chronic Pain
150 participants ages 18-23 with Chronic Pain
干预措施: Empowered Relief (Behavioral)
PRIME Sample
1200 participants with chronic pain
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
PRIME Sample
1200 participants with chronic pain
干预措施: Empowered Relief (Behavioral)
Chronic Pelvic Pain
150 participants with Chronic Pelvic Pain
干预措施: Empowered Relief (Behavioral)
Lupus Chronic Pain Cohort
150 participants with Lupus and Chronic Pain
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
Lupus Chronic Pain Cohort
150 participants with Lupus and Chronic Pain
干预措施: Empowered Relief (Behavioral)
Chronic Pelvic Pain
150 participants with Chronic Pelvic Pain
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
Young Adult (18-23) Chronic Pain
150 participants ages 18-23 with Chronic Pain
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
结局指标
主要结局
Pain Intensity
时间窗: 6 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Interference
时间窗: 6 months
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Pain Intensity
时间窗: 1 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Intensity
时间窗: 2 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Intensity
时间窗: 3 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Interference
时间窗: 1 month
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Interference
时间窗: 2 months
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Pain Interference
时间窗: 3 months
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
次要结局
- Pain Bothersomeness(6 months)
- Anger(6 months)
- Satisfaction with Social Roles/Responsibilities(6 months)
- Fatigue(6 months)
- Sleep Disturbance(6 months)
- Patient Global Impression of Change(6 months)
- Pain Catastrophizing(6 months)
- Anxiety(6 months)
- Depression(6 months)
- Sleep Disturbance(1 month)
- Sleep Disturbance(2 months)
- Sleep Disturbance(3 months)
- Pain Bothersomeness(1 month)
- Pain Bothersomeness(2 months)
- Pain Bothersomeness(3 months)
- Pain Catastrophizing(1 months)
- Pain Catastrophizing(2 months)
- Pain Catastrophizing(3 months)
- Anxiety(1 month)
- Anxiety(2 months)
- Anxiety(3 months)
- Satisfaction with Social Roles/Responsibilities(1 month)
- Satisfaction with Social Roles/Responsibilities(2 months)
- Satisfaction with Social Roles/Responsibilities(3 months)
- Patient Global Impression of Change(1months)
- Patient Global Impression of Change(2 month)
- Patient Global Impression of Change(3 months)
- Depression(1 month)
- Depression(2 months)
- Depression(3 months)
- Fatigue(1 month)
- Fatigue(2 months)
- Fatigue(3 months)
- Anger(1 month)
- Anger(2 months)
- Anger(3 months)
研究者
Beth Darnall
Professor
Stanford University