Tailored Non-Pharmacotherapy Services for Chronic Pain

(RESOLVE Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Recent CBT, Substance use disorder, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

2333 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{2 3 5 9 10}

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

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)

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.

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

Group I: Usual Care plus information Active Control 1 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 program Active Control 1 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 program Active Control 1 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)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Web-based cognitive behavioral therapy (CBT) effectively reduced pain interference and intensity in patients with chronic musculoskeletal pain, regardless of whether they received additional phone-based support from nurses.

The study found no significant differences in pain-related outcomes between the group receiving nurse support and the control group, except for a slight improvement in sleep disturbance favoring the nurse support group, suggesting that web-based CBT alone may be a cost-effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Supported Web-Based Cognitive Behavioral Therapy for Chronic Musculoskeletal Pain: A Randomized Controlled Trial. Diab, R., Bomar, R., Slaven, J., et al.[2023]

Adding telephone support to the Reboot Online pain management program significantly improved participant enrollment (93% vs. 78%) and commencement rates (91% vs. 60%) compared to the program without support, indicating that clinician guidance can enhance initial engagement.

Despite the increased engagement, the overall completion rates and clinical effectiveness of the program were similar between the two groups, suggesting that while support helps get participants started, it may not influence their ability to finish the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial. Gardner, T., Schultz, R., Haskelberg, H., et al.[2022]

A study involving 278 patients with chronic back pain found that an AI-driven cognitive behavioral therapy for chronic pain (AI-CBT-CP) was noninferior to standard telephone CBT-CP, showing similar effectiveness in reducing disability and pain over 6 months.

AI-CBT-CP not only achieved better clinical outcomes for patients but also required less than half the therapist time compared to traditional CBT-CP, suggesting it could improve access to treatment for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Piette, JD., Newman, S., Krein, SL., et al.[2023]

In a study of 108 individuals with chronic back pain undergoing cognitive behavioral therapy (CBT-CP), 46% experienced a significant reduction in pain intensity, while 66% increased their daily steps, indicating the therapy's effectiveness.

Most participants who responded positively to treatment achieved meaningful changes within 4 weeks for pain reduction and 2 weeks for increased activity, highlighting the potential for early benefits from CBT-CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. MacLean, RR., Buta, E., Higgins, DM., et al.[2023]

Guided internet-based cognitive-behavioral therapy (iCBT) has been shown to be effective for chronic pain management, outperforming both passive and active control conditions in improving psychological, physical, and daily life outcomes across 33 studies with 5133 participants.

The treatment was generally safe with high satisfaction rates and minor adverse events, although dropout rates were influenced by factors like time commitment and technical issues, suggesting that optimizing delivery methods could enhance patient retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review. Terpstra, JA., van der Vaart, R., van Beugen, S., et al.[2022]

The COPES trial demonstrated that interactive voice response-based cognitive behavioral therapy (IVR-CBT) is as effective as in-person CBT for managing chronic back pain, with similar reductions in pain intensity after 3 months.

IVR-CBT also showed lower dropout rates, suggesting it may be a more accessible and convenient option for patients, enhancing their ability to engage in treatment compared to traditional in-person therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. Heapy, AA., Higgins, DM., Goulet, JL., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Becoming an eCoach: Training therapists in online cognitive-behavioral therapy for chronic pain. [2019]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Nurse-Supported Web-Based Cognitive Behavioral Therapy for Chronic Musculoskeletal Pain: A Randomized Controlled Trial. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of a Remotely Delivered Cognitive Behavioral Coaching Program on the Self-Rated Functional Disability of Participants with Low Back Pain. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. [2019]