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

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05612750
Collaborator
Patient-Centered Outcomes Research Institute (Other)
1,200
Enrollment
2
Arms
64
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Education
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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 (Care Provider)
Masking Description:
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.
Primary Purpose:
Supportive Care
Official Title:
Comparative Effectiveness of Online Cognitive Behavioral Therapy vs. An Online Single-Session Pain Relief Skills Class for Chronic Pain - The PROGRESS Study
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
May 1, 2028
Anticipated Study Completion Date :
May 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Empowered Relief

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
Participants will receive one of two educational programs.
Experimental: Online 8-session Cognitive Behavioral Therapy

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
Participants will receive one of two educational programs.

Outcome Measures

Primary Outcome Measures

  1. Pain Intensity [1 months]

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

  2. Pain Intensity [2 months]

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

  3. Pain Intensity [3 months]

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

  4. Pain Intensity [6 months]

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

  5. Pain Interference [1 month]

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

  6. Pain Interference [2 months]

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

  7. Pain Interference [3 months]

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

  8. Pain Interference [6 months]

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

Secondary Outcome Measures

  1. Sleep Disturbance [1 month]

    Compare treatment groups on the PROMIS Sleep Disturbance 6-item

  2. Sleep Disturbance [2 months]

    Compare treatment groups on the PROMIS Sleep Disturbance 6-item

  3. Sleep Disturbance [3 months]

    Compare treatment groups on the PROMIS Sleep Disturbance 6-item

  4. Sleep Disturbance [6 months]

    Compare treatment groups on the PROMIS Sleep Disturbance 6-item

  5. Pain Bothersomeness [1 month]

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

  6. Pain Bothersomeness [2 months]

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

  7. Pain Bothersomeness [3 months]

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

  8. Pain Bothersomeness [6 months]

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

  9. Pain Catastrophizing [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 [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 [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 [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 [1 month]

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

  14. Anxiety [2 months]

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

  15. Anxiety [3 months]

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

  16. Anxiety [6 months]

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

  17. Satisfaction with Social Roles/Responsibilities [1 month]

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

  18. Satisfaction with Social Roles/Responsibilities [2 months]

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

  19. Satisfaction with Social Roles/Responsibilities [3 months]

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

  20. Satisfaction with Social Roles/Responsibilities [6 months]

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

  21. Patient Global Impression of Change [1months]

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

  22. Patient Global Impression of Change [2 month]

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

  23. Patient Global Impression of Change [3 months]

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

  24. Patient Global Impression of Change [6 months]

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

  25. Depression [1 month]

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

  26. Depression [2 months]

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

  27. Depression [3 months]

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

  28. Depression [6 months]

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

  29. Fatigue [1 month]

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

  30. Fatigue [2 months]

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

  31. Fatigue [3 months]

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

  32. Fatigue [6 months]

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

  33. Anger [1 month]

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

  34. Anger [2 months]

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

  35. Anger [3 months]

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

  36. Anger [6 months]

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

Other Outcome Measures

  1. Exploratory Outcome Health Service Utilization [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. At least 18 years of age or older of either sex (and all genders).

  2. Chronic pain (pain that occurs on at least half of the days of 3 months or more).

  3. Past-month average pain intensity score of at least 3/10.

  4. Ability to adhere to and complete study protocols.

Exclusion Criteria:

  1. Inability to provide informed consent.

  2. Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment.

  3. Active suicidality at screening.

  4. Study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort.

  5. Receipt of either study treatment in the past 3 months.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stanford University
  • Patient-Centered Outcomes Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beth Darnall, Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT05612750
Other Study ID Numbers:
  • IRB-65439
First Posted:
Nov 10, 2022
Last Update Posted:
Nov 10, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Chronic Pain

Study Results

No Results Posted as of Nov 10, 2022