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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lupus Chronic Pain Cohort | Experimental | 150 participants with Lupus and Chronic Pain |
|
| Chronic Pelvic Pain | Experimental | 150 participants with Chronic Pelvic Pain |
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| Young Adult (18-23) Chronic Pain | Experimental | 150 participants ages 18-23 with Chronic Pain |
|
| PRIME Sample | Experimental | 1200 participants with chronic pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Behavioral | A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm. |
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome Health Service Utilization | We will utilize EMR and database records to compare treatment groups for healthcare utilization (e.g., medical visits) during final 3 months of the study vs. 3 months prior to enrollment. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma A Adair, BS | Contact | 6097448937 | eadair@stanford.edu | |
| Corinne Jung, PhD | Contact | (650) 724-0522 | Cejung@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix VA Health Care System | Not yet recruiting | Phoenix | Arizona | 85012 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41712512 | Derived | Adair Monson E, Mardian A, Saxena K, Dorsonne B, Hailu AY, Heggan E, Riazi G, Slater K, Poupore-King H, Clifton J, Perez L, Tian L, Porter J, Denton S, Hanson ER, Miefert J, Thorn BE, Mackey SC, Cheung M, Darnall BD. Randomized Comparative Effectiveness Study of 1-Session vs. 8-Session Online Behavioral Treatment for Chronic Pain: Protocol for the national PROGRESS study. Pain Med. 2026 Feb 19:pnag027. doi: 10.1093/pm/pnag027. Online ahead of print. |
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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).
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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.
| Empowered Relief | Behavioral | A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm. |
|
| 6 months |
| 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 |
| SCAN Health Plan | Recruiting | Long Beach | California | 90806 | United States |
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| Humana | Not yet recruiting | Louisville | Kentucky | 40202 | United States |
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| Lehigh Valley Health Network | Recruiting | Allentown | Pennsylvania | 18103 | United States |
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| Intermountain Healthcare | Recruiting | Salt Lake City | Utah | 84103 | United States |
|
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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