Cognitive Behavioral Therapy for Chronic Pain

Overseen By Gregory P Beehler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Opioids, Benzodiazepines

Disqualifiers: Substance use, Unstable psychiatric, Neurocognitive disorder, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Brief Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) can help Veterans manage chronic pain more effectively than standard care alone. The trial compares two groups: one receives usual care from their primary doctor, while the other receives usual care plus six sessions of CBT-CP. The study seeks Veterans who have experienced muscle or bone pain for over three months, which interferes with daily activities. Participants in the CBT-CP group will learn skills such as relaxation techniques and managing unhelpful thoughts about pain. The goal is to assess whether CBT-CP can enhance daily functioning and reduce pain-related distress. As an unphased trial, this study offers Veterans the chance to explore new methods for managing chronic pain and improving quality of life.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. However, if you are on pain or psychiatric medications, your dose should have been stable for the last two months.

What prior data suggests that Brief CBT for Chronic Pain is safe?

Research shows that Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is generally safe for most people. Studies have found that it can reduce pain and improve overall well-being. This therapy includes six sessions focusing on understanding pain, managing activities, learning relaxation techniques, and developing coping skills.

Reports have not identified major safety issues with Brief CBT-CP. Since it doesn't involve medication, it avoids drug-related side effects. Most people handle this therapy well, and many notice improvements after just a few sessions. This suggests that the therapy is both effective and safe for managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Brief Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) because it offers a structured, short-term approach designed to empower patients with self-management skills. Unlike conventional treatments that often rely heavily on medication, CBT-CP focuses on teaching patients how to modify unhelpful thoughts and engage in balanced physical activity, which can lead to long-term pain management benefits without the side effects associated with drugs. The therapy's emphasis on relapse prevention and independent skill use gives patients tools to manage their pain more effectively over time.

What evidence suggests that Brief CBT for Chronic Pain might be an effective treatment for chronic pain?

Studies have shown that Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP), which participants in this trial may receive, effectively helps people manage their pain. Patients reported less interference with daily activities and reduced emotional distress. Research indicates that Brief CBT-CP boosts confidence in managing pain and reduces negative thoughts about it. This therapy includes education, relaxation techniques, and coping strategies to help people handle pain better. Overall, Brief CBT-CP has proven to be a promising approach for improving the quality of life for those with chronic pain. ^{1 5 6 7 8}

Who Is on the Research Team?

Gregory P. Beehler, PhD

Principal Investigator

VA Western New York Healthcare System, Buffalo, NY

Are You a Good Fit for This Trial?

Veterans aged 18-79 with chronic musculoskeletal pain and functional impairment, conversant in English, stable on any pain or psychiatric meds for two months, and have used VA primary care in the past year. Excluded are those with substance use problems, unstable psychiatric status, pending disability claims, recent psychotherapy for pain, planned surgeries for pain or imminent suicide risk.

Inclusion Criteria

Conversant in English

I am a veteran aged between 18 and 79.

My pain medication dose has been the same for the last two months.

Exclusion Criteria

You have been deemed to be at high risk of attempting to harm yourself.

I have had or will have surgery to manage pain.

I am receiving mental health services not related to chronic pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brief CBT-CP in addition to usual primary care treatment, consisting of six 30-minute sessions over 6-12 weeks

6-12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month follow-up

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Brief CBT for Chronic Pain
• Treatment as usual

Trial Overview The trial is testing Brief Cognitive Behavioral Therapy (CBT) for Chronic Pain against usual primary care treatments. It aims to see if six sessions of Brief CBT can improve physical activity interference due to pain, psychological distress and other outcomes compared to standard care.

How Is the Trial Designed?

Group I: Treatment as usual only Experimental Treatment 1 Intervention

Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.

Group II: Brief CBT for Chronic Pain and treatment as usual Experimental Treatment 2 Interventions

Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

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

Cognitive behavioral therapy for chronic pain supported by ... Cognitive behavioral therapy (CBT) is effective for chronic pain. •. Telephone and digital CBT delivery may exacerbate inequities for at-risk patients.

2. 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).

3. scholars.uthscsa.edu scholars.uthscsa.edu/en/publications/brief-cognitive-behavioral-therapy-for-chronic-pain-results-from-

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) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04724694

Brief Cognitive Behavioral Therapy for Chronic Pain to ... ... Brief CBT-CP leads to improvement in patient outcomes. Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain ...

5. va.gov va.gov/PAINMANAGEMENT/CBT_CP/docs/Brief_CBT-CP_Patient_Guidebook-4-13-2021.pdf

Brief Cognitive Behavioral Therapy for Chronic Pain Cognitive Behavioral Therapy for Chronic Pain: Results from a clinical demonstration project in Primary Care Behavioral Health. ... anxiety, decreased efficiency, ...

6. reporter.nih.gov reporter.nih.gov/search/f8r1ElfJI0im-H2judquyg/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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03490981

Brief Cognitive Behavioral Therapy for Chronic Pain Participants assigned to Brief CBT-CP will receive six sessions of treatment in 30-minute appointments. This intervention will include education and goal ...

8. 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 ...