Cognitive Behavioral Therapy for Chronic Pain

(CP-SMI Trial)

Overseen By Letitia Travaglini, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use, Acute pain, Limited mobility

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) in helping Veterans with serious mental illnesses and chronic low back pain. The goal is to determine if this therapy can improve daily functioning, reduce pain severity, and enhance quality of life. Participants will either engage in CBT-CP, focusing on pain management skills, or a Health & Wellness program, covering general well-being topics. Veterans with chronic back pain and a diagnosis of a serious mental illness, such as schizophrenia or bipolar disorder, who are not currently dealing with severe substance use issues, might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to understanding how CBT-CP can benefit Veterans with complex health needs.

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 using Cognitive Behavioral Therapy for pain management, so it's best to discuss your medications with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is safe and well-tolerated for treating chronic pain. In studies with Veterans, CBT-CP effectively managed pain without causing harm, and no serious side effects were reported. The Department of Veterans Affairs (VA) already uses this therapy for managing chronic pain, underscoring its safety record. The therapy involves learning to handle pain through problem-solving and education, without medication or invasive procedures, which further reduces the risk of negative reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) because it focuses on empowering patients with skills to manage their pain through a structured psychological approach. Unlike standard treatments for chronic pain, which often rely on medications or physical therapies, CBT-CP uses a 12-session protocol to teach cognitive and behavioral skills tailored to pain management. This approach not only educates patients about pain but also equips them with strategies to set goals and implement learned techniques in daily life, potentially reducing their reliance on medication and improving overall quality of life.

What evidence suggests that Cognitive Behavioral Therapy for Chronic Pain is effective for chronic low back pain?

This trial will compare Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) with a Health & Wellness (H&W) program. Research has shown that CBT-CP helps people manage their pain more effectively. In one study, patients who received CBT-CP experienced fewer difficulties with pain-related activities than those who did not. Another review found that CBT-CP improved both therapists' skills and outcomes for Veterans dealing with chronic pain. These therapies teach patients how to manage their pain more effectively, enhancing their quality of life. Overall, strong evidence supports the benefits of CBT-CP for Veterans with chronic pain, particularly those facing mental health challenges. ^{5 6 7 8 9}

Who Is on the Research Team?

Letitia Travaglini, PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

This trial is for Veterans with serious mental illnesses (SMI) like schizophrenia, bipolar depression, and other mood disorders who also suffer from chronic musculoskeletal pain. Participants should have chronic low back pain but not be involved in any conflicting treatments or studies.

Inclusion Criteria

Have regular access to a telephone

I can understand and sign the consent form.

Enrolled in outpatient programming within a VISN 5 health care facility at time of consent

Exclusion Criteria

Are engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care (as determined by treating provider)

I have been in CBT for chronic pain within the last year.

I can walk a city block without pain or mobility issues affecting my participation in therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) or Health & Wellness sessions

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

Trial Overview The study tests Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) against a Health & Wellness program to see which helps more with pain-related functioning, quality of life, and severity of pain in Veterans with SMI.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Experimental Treatment 1 Intervention

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) will be conducted in accordance with the Cognitive Behavioral Therapy for Chronic Pain: Therapist Manual and the VA Evidence-Based Practice (EBP) roll-out training. CBT-CP consists of a 12-session protocol, including an initial assessment session (BL assessment; Session 1), 10 content-specific sessions (pain education, goal-setting, cognitive and behavioral skill building; Sessions 2-11), and a booster session scheduled approximately one month after the final CBT-CP session (Session 12). Participants randomized to the CBT-CP condition (n = 30) will complete one 60-minute individual session per week. Each CBT-CP session will be led by a trained study interventionist using a manualized curriculum, following a basic structure including review of previous session material, introduction of new information or skills, and discussion of how to implement learned material into a home action plan.

Group II: Health & Wellness (H&W) Active Control 1 Intervention

Health \& Wellness (H\&W) was developed by VISN 5 MIRECC investigators and consists of psychoeducation on topics related to physical and emotional wellbeing. Its structure is similar to CBT-CP (10 weekly individual 60-minute sessions, no booster session). Each Health \& Wellness session will be led by a trained interventionist using a manualized curriculum that includes review of previous session material, introduction of new information, and discussion of a range of health-related topics (physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating) that do not include pain. Typical sessions include discussion of the impact of the topic on overall health and well-being, identifying benefits and challenges to improving or maintaining health in that area, and strategies to address challenges in that area.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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]

A multidisciplinary pain management program based on cognitive behavioral therapy (CBT) significantly improved health-related quality of life (HRQL) and reduced pain intensity in 113 participants over an 8-week period.

The program also enhanced participants' readiness to change their approach to managing chronic pain, suggesting it can effectively break the cycle of chronic pain by addressing psychosocial factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a multidisciplinary pain management programme managing chronic pain on pain perceptions, health-related quality of life and stages of change--A non-randomized controlled study. Dysvik, E., Kvaløy, JT., Stokkeland, R., et al.[2022]

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]

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]

Cognitive-behavioral therapy (CBT) is an effective first-line treatment for chronic pain, supported by numerous randomized controlled trials showing improvements in pain and related issues across various chronic pain syndromes.

Recent innovations in CBT delivery, such as web-based and telephone formats, have expanded its accessibility and effectiveness for diverse populations, including children and older adults, indicating a promising direction for future treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Ehde, DM., Dillworth, TM., Turner, JA.[2022]

In a study of 463 individuals with chronic pain undergoing a 3-week interdisciplinary cognitive behavioral therapy (CBT) program, two distinct change trajectories in pain catastrophizing were identified: one group showed significant improvement while the other remained unchanged.

Those who experienced a reduction in pain catastrophizing also reported greater improvements in pain interference, mood, and overall quality of life, highlighting the importance of addressing cognitive responses in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain catastrophizing as a treatment process variable in cognitive behavioural therapy for adults with chronic pain. Gilliam, WP., Schumann, ME., Cunningham, JL., et al.[2021]

A survey of 152 physical therapists revealed that while only a minority currently use cognitive-behavioral therapy (CBT) techniques like activity pacing (81%) and pleasurable activity scheduling (30%) for treating older patients with chronic pain, there is a significant interest in incorporating these methods into practice.

Barriers to using CBT include a lack of knowledge and skills, concerns about reimbursement, and time constraints, indicating that addressing these issues could enhance the integration of CBT into physical therapy for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Beissner, K., Henderson, CR., Papaleontiou, M., et al.[2021]

A study involving 14 patients with chronic pain explored their experiences with a high-intensity cognitive-behavioral therapy (CBT) protocol, which included various innovative techniques like tactile attention-shift training and video feedback.

Patients reported varying levels of helpfulness from different CBT components, with memory work being beneficial for nine patients and visual feedback being very helpful for six, indicating that personalized approaches in CBT may enhance treatment outcomes for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention and Imagery in Cognitive-Behavioral Therapy for Chronic Pain: An Exploratory Study. Kutsuzawa, K., Taguchi, K., Shimizu, E.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10009772/

Cognitive Behavioral Therapy for Chronic Pain in Veterans The aim of this project was to review patient outcomes to determine the effectiveness of the VA's CBT-CP treatment.

2. 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 ...

3. 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 ...

4. 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) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04724694

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

6. va.gov va.gov/PAINMANAGEMENT/CBT_CP/index.asp

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) The Department of Veterans Affairs (VA) offers Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) as an effective treatment for reducing the negative ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39671512/

Safety and Tolerability of a Brief Cognitive-Behavioral ... Brief CBT-CP appears to be a safe and well-tolerated treatment for Veterans with chronic noncancer pain who are also at risk for suicide.

8. academic.oup.com academic.oup.com/milmed/article/190/7-8/1629/7923186

Safety and Tolerability of a Brief Cognitive-Behavioral Therapy ... Brief CBT-CP appears to be a safe and well-tolerated treatment for Veterans with chronic noncancer pain who are also at risk for suicide.

9. va.gov va.gov/PAINMANAGEMENT/CBT_CP/Veterans.asp

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) CBT-CP equips individuals with an active, problem-solving approach to manage and decrease the challenges associated with chronic pain.