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NCT Number: NCT05612750

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

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).

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Key information

Conditions

Pain, Chronic Chronic Pain Lupus Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix VA Health Care System, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Intensity

    Time frame: 1 months

    Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)

  2. Pain Intensity

    Time frame: 2 months

    Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)

  3. Pain Intensity

    Time frame: 3 months

    Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)

  4. Pain Intensity

    Time frame: 6 months

    Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)

  5. Pain Interference

    Time frame: 1 month

    Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)

  6. Pain Interference

    Time frame: 2 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.

  7. Pain Interference

    Time frame: 3 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.

  8. Pain Interference

    Time frame: 6 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.

Secondary outcomes

  1. Sleep Disturbance

    Time frame: 1 month

    Compare treatment groups on the PROMIS Sleep Disturbance 6-item

  2. Sleep Disturbance

    Time frame: 2 months

    Compare treatment groups on the PROMIS Sleep Disturbance 6-item

  3. Sleep Disturbance

    Time frame: 3 months

    Compare treatment groups on the PROMIS Sleep Disturbance 6-item

  4. Sleep Disturbance

    Time frame: 6 months

    Compare treatment groups on the PROMIS Sleep Disturbance 6-item

  5. Pain Bothersomeness

    Time frame: 1 month

    Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)

  6. Pain Bothersomeness

    Time frame: 2 months

    Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)

  7. Pain Bothersomeness

    Time frame: 3 months

    Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)

  8. Pain Bothersomeness

    Time frame: 6 months

    Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)

  9. Pain Catastrophizing

    Time frame: 1 months

    Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.

  10. Pain Catastrophizing

    Time frame: 2 months

    Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.

  11. Pain Catastrophizing

    Time frame: 3 months

    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

  12. Pain Catastrophizing

    Time frame: 6 months

    Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.

  13. Anxiety

    Time frame: 1 month

    Compare treatment groups for anxiety using the PROMIS Anxiety 6-item

  14. Anxiety

    Time frame: 2 months

    Compare treatment groups for anxiety using the PROMIS Anxiety 6-item

  15. Anxiety

    Time frame: 3 months

    Compare treatment groups for anxiety using the PROMIS Anxiety 6-item

  16. Anxiety

    Time frame: 6 months

    Compare treatment groups for anxiety using the PROMIS Anxiety 6-item

  17. Satisfaction with Social Roles/Responsibilities

    Time frame: 1 month

    Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities

  18. Satisfaction with Social Roles/Responsibilities

    Time frame: 2 months

    Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities

  19. Satisfaction with Social Roles/Responsibilities

    Time frame: 3 months

    Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities

  20. Satisfaction with Social Roles/Responsibilities

    Time frame: 6 months

    Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities

  21. Patient Global Impression of Change

    Time frame: 1months

    Compare treatment groups for PROMISE 1 item Global Impression of Change scale

  22. Patient Global Impression of Change

    Time frame: 2 month

    Compare treatment groups for PROMISE 1 item Global Impression of Change scale

  23. Patient Global Impression of Change

    Time frame: 3 months

    Compare treatment groups for PROMISE 1 item Global Impression of Change scale

  24. Patient Global Impression of Change

    Time frame: 6 months

    Compare treatment groups for PROMISE 1 item Global Impression of Change scale

  25. Depression

    Time frame: 1 month

    Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.

  26. Depression

    Time frame: 2 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.

  27. Depression

    Time frame: 3 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.

  28. Depression

    Time frame: 6 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.

  29. Fatigue

    Time frame: 1 month

    Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.

  30. Fatigue

    Time frame: 2 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.

  31. Fatigue

    Time frame: 3 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.

  32. Fatigue

    Time frame: 6 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.

  33. Anger

    Time frame: 1 month

    Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.

  34. Anger

    Time frame: 2 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.

  35. Anger

    Time frame: 3 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.

  36. Anger

    Time frame: 6 months

    Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.

Other outcomes

  1. Exploratory Outcome Health Service Utilization

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Corinne Jung, PhD

CONTACT

[email protected]

(650) 724-0522

Emma A Adair, BS

CONTACT

[email protected]

6097448937

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: PROGRESS

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Nov 10, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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