2333 Participants Needed

Tailored Non-Pharmacotherapy Services for Chronic Pain

(RESOLVE Trial)

Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kaiser Permanente
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on non-drug treatments for chronic pain, so it's best to discuss your medications with the trial coordinators.

What data supports the effectiveness of the treatment Online CBT-CP based program, Virtual coach-led CBT-CP, Virtual coach-led CBT-CP based program, Web-based CBT-CP for chronic pain?

Research shows that cognitive behavioral therapy for chronic pain (CBT-CP) is effective in managing pain, and making it available online can help reach more people, especially those in rural areas. Studies suggest that web-based CBT can be as effective as face-to-face therapy, and adding remote support may improve outcomes.12345

Is cognitive behavioral therapy for chronic pain (CBT-CP) safe for humans?

Cognitive behavioral therapy for chronic pain (CBT-CP) is considered a safe alternative to opioid pain medications.26789

How is the Online CBT-CP based program for chronic pain different from other treatments?

The Online CBT-CP based program is unique because it provides cognitive behavioral therapy (CBT) for chronic pain through the internet, making it more accessible to people in rural or underserved areas who might not have access to traditional in-person therapy. This approach can help overcome barriers to treatment by offering a flexible and potentially more affordable option.235910

What is the purpose of this trial?

The RESOLVE study is a multicenter comparative effectiveness trial of two cognitive behavioral therapy-based chronic pain (CBT-CP) treatments delivered via telehealth modalities: 1) online program and 2) live, coach-led, virtual sessions (telephone and/or video conference).

Research Team

LL

Lynn L DeBar, PhD, MPH

Principal Investigator

Kaiser Permanente

Eligibility Criteria

This trial is for adults over 18 with chronic pain who are enrolled in one of the participating health care systems. They must speak English, have internet and phone access, and have had recent healthcare visits for non-cancer-related musculoskeletal pain. People can't join if they've had recent CBT for pain, substance abuse treatment, or planned surgeries related to their condition.

Inclusion Criteria

I speak English or don't need an interpreter.
Do not have ICD-10 codes indicating severe cognitive impairment precluding participation in a behavioral/ lifestyle change program
Be able to participate in either of the active interventions (i.e., have internet and phone access required for accessing treatments)
See 8 more

Exclusion Criteria

I am starting or currently in cognitive behavioral therapy for pain.
I have had cognitive behavioral therapy for pain in the last 6 months.
I am scheduled for surgery to address my pain within the next year.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive behavioral therapy-based chronic pain treatments delivered via telehealth modalities, including an online program and live, coach-led virtual sessions

8 weeks
8 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of pain severity and quality of life outcomes

12 months

Treatment Details

Interventions

  • Online CBT-CP based program
  • Virtual coach-led CBT-CP
  • Virtual coach-led CBT-CP based program
  • Web-based CBT-CP
Trial Overview The RESOLVE study tests two telehealth treatments for chronic pain: an online cognitive behavioral therapy-based program (CBT-CP) and a similar program led by a virtual coach via calls or video. Participants will receive either method to see which is more effective.
Participant Groups
3Treatment groups
Active Control
Group I: Usual Care plus informationActive Control1 Intervention
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
Group II: Online CBT-CP based programActive Control1 Intervention
Self-completed, online program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted)
Group III: Virtual coach-led CBT-CP based programActive Control1 Intervention
Live, coach-led program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials
563
Recruited
27,400,000+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

Northwestern University

Collaborator

Trials
1,674
Recruited
989,000+

Essentia Health

Collaborator

Trials
27
Recruited
107,000+

Georgia State University

Collaborator

Trials
71
Recruited
33,600+

Findings from Research

A 1.5-day training program for therapists on online cognitive-behavioral therapy (iCBT) for chronic pain was developed, focusing on knowledge, skills, motivation, and organization, which are crucial for effective implementation.
Initial evaluations from 22 participating therapists indicated positive attitudes towards e-health and high acceptance of iCBT, suggesting that the training could enhance the integration of iCBT into clinical practice, although organizational support remains essential.
Becoming an eCoach: Training therapists in online cognitive-behavioral therapy for chronic pain.Terpstra, JA., van der Vaart, R., Spillekom-van Koulil, S., et al.[2019]
The RESOLVE trial is a large-scale, 3-arm randomized control trial designed to compare the effectiveness of telephonic/video and online CBT for chronic pain against usual care, involving diverse populations across urban and rural areas.
This study aims to assess not only the clinical effectiveness of these CBT interventions in reducing pain severity but also their cost-effectiveness, potentially improving access to treatment for underserved populations.
Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.Mayhew, M., Balderson, BH., Cook, AJ., et al.[2023]
Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) shows promising effectiveness in primary care settings, with significant improvements in pain intensity and functional limitations observed by the third appointment among 118 patients.
The most effective components of Brief CBT-CP included psychoeducation, goal setting, pacing, and relaxation training, suggesting that these strategies are beneficial for managing chronic pain without relying on medication.
Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health.Beehler, GP., Murphy, JL., King, PR., et al.[2020]

References

Becoming an eCoach: Training therapists in online cognitive-behavioral therapy for chronic pain. [2019]
Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. [2023]
Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. [2020]
Nurse-Supported Web-Based Cognitive Behavioral Therapy for Chronic Musculoskeletal Pain: A Randomized Controlled Trial. [2023]
The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial. [2022]
Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. [2023]
Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial. [2023]
Effects of a Remotely Delivered Cognitive Behavioral Coaching Program on the Self-Rated Functional Disability of Participants with Low Back Pain. [2022]
Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. [2019]
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