Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effectiveness of Online Cognitive Behavioral Therapy vs. An Online Single-Session Pain Relief Skills Class for Chronic Pain - The PROGRESS Study

Conditions
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Pain, Chronic

Intervention / Treatment
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* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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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 3/10. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A pragmatic clinical trial randomizing to one of two (standard of care) online group behavioral treatments: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empowered Relief<br>A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm. | Behavioral: Education<br>* Participants will receive one of two educational programs.<br>|
| Experimental: Online 8-session Cognitive Behavioral Therapy<br>A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm. | Behavioral: Education<br>* Participants will receive one of two educational programs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10) | 1 months | 
| Pain Intensity | Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10) | 2 months | 
| Pain Intensity | Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10) | 3 months | 
| Pain Intensity | Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10) | 6 months | 
| Pain Interference | Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10) | 1 month | 
| Pain Interference | Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale. | 2 months | 
| Pain Interference | Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale. | 3 months | 
| Pain Interference | Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Disturbance | Compare treatment groups on the PROMIS Sleep Disturbance 6-item | 1 month | 
| Sleep Disturbance | Compare treatment groups on the PROMIS Sleep Disturbance 6-item | 2 months | 
| Sleep Disturbance | Compare treatment groups on the PROMIS Sleep Disturbance 6-item | 3 months | 
| Sleep Disturbance | Compare treatment groups on the PROMIS Sleep Disturbance 6-item | 6 months | 
| Pain Bothersomeness | Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10) | 1 month | 
| Pain Bothersomeness | Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10) | 2 months | 
| Pain Bothersomeness | Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10) | 3 months | 
| Pain Bothersomeness | Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10) | 6 months | 
| Pain Catastrophizing | Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. | 1 months | 
| Pain Catastrophizing | Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. | 2 months | 
| Pain Catastrophizing | Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. We aim to obtain >30% reduction in PCS scores after the intervention | 3 months | 
| Pain Catastrophizing | Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. | 6 months | 
| Anxiety | Compare treatment groups for anxiety using the PROMIS Anxiety 6-item | 1 month | 
| Anxiety | Compare treatment groups for anxiety using the PROMIS Anxiety 6-item | 2 months | 
| Anxiety | Compare treatment groups for anxiety using the PROMIS Anxiety 6-item | 3 months | 
| Anxiety | Compare treatment groups for anxiety using the PROMIS Anxiety 6-item | 6 months | 
| Satisfaction with Social Roles/Responsibilities | Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities | 1 month | 
| Satisfaction with Social Roles/Responsibilities | Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities | 2 months | 
| Satisfaction with Social Roles/Responsibilities | Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities | 3 months | 
| Satisfaction with Social Roles/Responsibilities | Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities | 6 months | 
| Patient Global Impression of Change | Compare treatment groups for PROMISE 1 item Global Impression of Change scale | 1months | 
| Patient Global Impression of Change | Compare treatment groups for PROMISE 1 item Global Impression of Change scale | 2 month | 
| Patient Global Impression of Change | Compare treatment groups for PROMISE 1 item Global Impression of Change scale | 3 months | 
| Patient Global Impression of Change | Compare treatment groups for PROMISE 1 item Global Impression of Change scale | 6 months | 
| Depression | Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale. | 1 month | 
| Depression | Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale. | 2 months | 
| Depression | Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale. | 3 months | 
| Depression | Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale. | 6 months | 
| Fatigue | Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale. | 1 month | 
| Fatigue | Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale. | 2 months | 
| Fatigue | Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale. | 3 months | 
| Fatigue | Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale. | 6 months | 
| Anger | Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale. | 1 month | 
| Anger | Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale. | 2 months | 
| Anger | Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale. | 3 months | 
| Anger | Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale. | 6 months |