Comparative Effectiveness of Online Cognitive Behavioral Therapy vs. An Online Single-Session Pain Relief Skills Class for Chronic Pain - The PROGRESS Study
Overview
- Phase
- Not Applicable
- Intervention
- Cognitive Behavioral Therapy (CBT)
- Conditions
- Pain, Chronic
- Sponsor
- Stanford University
- Enrollment
- 1650
- Locations
- 10
- Primary Endpoint
- Pain Intensity
- Status
- Recruiting
- Last Updated
- 12 days ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Beth Darnall
Professor
Stanford University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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 at screening.
- •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.
Arms & Interventions
Lupus Chronic Pain Cohort
150 participants with Lupus and Chronic Pain
Intervention: Cognitive Behavioral Therapy (CBT)
Lupus Chronic Pain Cohort
150 participants with Lupus and Chronic Pain
Intervention: Empowered Relief
Chronic Pelvic Pain
150 participants with Chronic Pelvic Pain
Intervention: Cognitive Behavioral Therapy (CBT)
Chronic Pelvic Pain
150 participants with Chronic Pelvic Pain
Intervention: Empowered Relief
Young Adult (18-23) Chronic Pain
150 participants ages 18-23 with Chronic Pain
Intervention: Cognitive Behavioral Therapy (CBT)
Young Adult (18-23) Chronic Pain
150 participants ages 18-23 with Chronic Pain
Intervention: Empowered Relief
PRIME Sample
1200 participants with chronic pain
Intervention: Cognitive Behavioral Therapy (CBT)
PRIME Sample
1200 participants with chronic pain
Intervention: Empowered Relief
Outcomes
Primary Outcomes
Pain Intensity
Time Frame: 6 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Interference
Time Frame: 6 months
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Pain Intensity
Time Frame: 1 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Intensity
Time Frame: 2 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Intensity
Time Frame: 3 months
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Interference
Time Frame: 1 month
Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)
Pain Interference
Time Frame: 2 months
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Pain Interference
Time Frame: 3 months
Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.
Secondary Outcomes
- 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)