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

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

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)?

Research shows that Cognitive Behavioral Therapy (CBT) is effective for managing chronic pain, with multiple studies indicating it helps improve pain and related issues. It has been successfully adapted for different groups, including children and older adults, and can be delivered in various formats like online or by phone, making it more accessible. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Chronic Pain safe for humans?

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is considered a safe alternative to medications like opioids for managing chronic pain. ^{1 2 3 4 6}

How is Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) different from other treatments for chronic pain?

CBT-CP is unique because it focuses on changing negative thought patterns about pain, such as pain catastrophizing, to improve mood and function. It can be delivered remotely, making it more accessible to people in rural or underserved areas, and has been adapted into a brief form for use in primary care settings. ^{2 3 4 7 8}

What is the purpose of this trial?

Chronic musculoskeletal pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic musculoskeletal pain leads to poorer mental and physical health-related functioning, representing a critical obstacle to rehabilitation and recovery for SMI Veterans. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to evaluate nonpharmacological pain management strategies in this population. This study aims to address this research and clinical gap by testing the efficacy of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI and chronic low back pain. The study will primarily evaluate the impact of CBT-CP on pain-related functioning, quality of life, and pain severity. This study will also examine relationships between pain and mental health symptoms, and how these relationships may change with CBT-CP completion.

Research Team

Letitia Travaglini, PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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]

References

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

Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. [2021]

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

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. [2022]

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

Attention and Imagery in Cognitive-Behavioral Therapy for Chronic Pain: An Exploratory Study. [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

Pain catastrophizing as a treatment process variable in cognitive behavioural therapy for adults with chronic pain. [2021]

8. England 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. [2022]