Cognitive Behavioral Therapy for Chronic Pain

(COPES ExTRA Trial)

No longer recruiting at 8 trial locations

Overseen By Kristin Mattocks, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Serious mental illness, Malignant cancer, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a new treatment, COPES, is more effective than the standard Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) typically provided to veterans. It targets individuals experiencing chronic musculoskeletal pain, such as persistent back or joint pain, who receive care through the Veterans Health Administration. Suitable candidates for this trial have experienced moderate to severe pain for over a year and can walk at least one block without significant difficulty. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance pain management for veterans.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these cognitive behavioral therapy methods are safe for chronic pain?

Research has shown that both Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) and Cooperative Pain Education and Self-management (COPES) are safe for individuals.

CBT-CP is generally well-tolerated by many patients. Studies suggest that veterans who participated in the program improved their pain management skills and overall well-being. CBT-CP is often used in medical settings, and no major negative effects have been commonly reported.

Similarly, COPES, a self-guided CBT program, has been tested with veterans who completed it at home. Studies found that it effectively helps manage chronic pain without major safety concerns. Participants reported less pain and fewer symptoms of depression.

Both treatments focus on teaching skills to better manage pain, and existing research supports their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) and COPES because these approaches offer a fresh take on managing chronic pain without relying on medications like opioids. Unlike traditional treatments that often focus on pharmaceutical solutions, CBT-CP works by helping patients change their thought patterns and behaviors related to pain, which can reduce the perception of pain and improve quality of life. COPES, on the other hand, emphasizes skills and strategies for coping with pain through personalized support, making it unique by providing a more tailored approach to pain management. These methods empower patients to take control of their pain management, potentially reducing dependency on medication and improving long-term outcomes.

What evidence suggests that this trial's treatments could be effective for chronic pain?

This trial will compare Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) with the COPES program. Studies have shown that CBT-CP reduces disability caused by pain, with more patients reporting significant improvements in pain management after six months. Research also shows that both therapists and patients benefit from CBT-CP training.

COPES, or Co-Operative Pain Education and Self-management, is another program based on CBT. It has proven as effective as in-person therapy for managing chronic pain. This program uses interactive voice response (IVR) technology, allowing people to access it from home. Evidence suggests that COPES effectively helps people manage their chronic pain remotely. ^{2 3 4 5 6}

Who Is on the Research Team?

Alicia Heapy, Phd

Principal Investigator

VA Office of Research and Development

Are You a Good Fit for This Trial?

This trial is for Veterans Health Administration patients with chronic musculoskeletal pain who can walk at least one block and don't have severe cognitive impairment, serious mental illness requiring recent hospitalization, active cancer, or are in hospice care. They must have moderate pain for a year and be able to use a phone without vision or hearing issues.

Inclusion Criteria

You are currently receiving treatment for long-term pain in your muscles or bones within the Veterans Health Administration (VHA) system.

You can safely walk at least one block and do not have diabetic foot ulcers.

You do not have a diagnosis of cancer or are receiving end-of-life care.

Exclusion Criteria

Patients not fitting criteria for inclusion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either COPES or standard VHA CBT-CP for chronic pain management

8-10 weeks

In-home treatment for COPES, in-person for CBT-CP

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Data collected through automated IVR calls

What Are the Treatments Tested in This Trial?

Interventions

• CBT-CP
• COPES

Trial Overview The COPES ExTRA trial is testing whether the COPES program is better than the standard Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) offered by the VHA. It's focused on helping veterans manage their long-term musculoskeletal pain more effectively.

How Is the Trial Designed?

Group I: data from veterans using CBT-CP Active Control 1 Intervention

Data from veterans using CBT-CP for chronic pain

Group II: data from veterans using COPES Active Control 1 Intervention

Data from veterans using COPES for chronic pain

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31318726/

Brief Cognitive Behavioral Therapy For Chronic Pain The aim of this project was to collect preliminary effectiveness data for Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP).

2. jamanetwork.com jamanetwork.com/journals/jama/article-abstract/2836795

Telehealth and Online Cognitive Behavioral Therapy ... This randomized clinical trial examines the effectiveness of remote, scalable cognitive behavioral therapy–based chronic pain (CBT-CP) ...

3. va.gov va.gov/painmanagement/docs/cbt-cp_therapist_manual.pdf

Cognitive Behavioral Therapy for Chronic Pain Program evaluation results indicate that the training in and implementation of these therapies have significantly enhanced therapist skills and Veteran outcomes ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666521224000310

Cognitive behavioral therapy for chronic pain supported by ... At six months, significantly more patients randomized to AI-CBT-CP had clinically meaningful improvements in pain-related disability [9] than patients receiving ...

5. academic.oup.com academic.oup.com/painmedicine/article/24/7/846/6885453

Using Daily Ratings to Examine Treatment Dose and ... Cognitive behavioral therapy for chronic pain (CBT-CP) has a strong evidence base, but little is known about when treatment benefits are achieved.

6. reporter.nih.gov reporter.nih.gov/search/15EEC10D4C8DC5D37598B8961CAA4A01A2FFCEB861BF/project-details/10909888

Brief Cognitive Behavioral Therapy for Chronic Pain ... On average, the majority of improvement was achieved in the first three sessions of treatment signaling that Brief CBT-CP can potentially produce rapid clinical ...