Cognitive Behavioral Therapy for Serious Mental Illness-related Chronic Pain

(CPSMI 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)

Approved in 1 Jurisdiction This treatment is already approved in other countries

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 tests the effectiveness of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) in helping Veterans with chronic pain and serious mental illnesses like schizophrenia or bipolar disorder. The researchers aim to determine if participants find this therapy practical and acceptable, and to gain insights into the interaction between pain and mental health symptoms. The trial includes two groups: one receives CBT-CP, while the other participates in a Health and Wellness program focusing on overall well-being. Individuals with chronic musculoskeletal pain and a serious mental illness diagnosis may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to enhance understanding of how therapy can improve the lives of Veterans with complex health needs.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it focuses on nonpharmacological pain management, so it's likely you can continue your medications unless otherwise advised by your healthcare provider.

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 might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that Cognitive Behavioral Therapy for Chronic Pain is safe for Veterans with serious mental illness?

Research has shown that Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is a safe and effective method for managing long-term pain. Studies have found that CBT-CP can reduce pain and enhance daily life without relying on medications like opioids. It achieves this by helping individuals change their thoughts and actions related to pain through a structured program. This approach is well-accepted among those with chronic pain, including individuals with serious mental health issues. Specifically, CBT-CP has improved outcomes for Veterans, making it a dependable choice for pain management. ^{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 offers a structured, psychological approach to managing chronic pain associated with serious mental illness, which is different from the typical reliance on medications like opioids or NSAIDs. Unlike standard treatments that primarily target physical symptoms, CBT-CP focuses on altering the thoughts and behaviors related to pain, aiming to reduce pain perception and improve coping strategies. This therapy involves a 12-session protocol that not only addresses pain education and skill-building but also includes a booster session to reinforce learning, potentially leading to more sustainable pain management and improved quality of life.

What evidence suggests that Cognitive Behavioral Therapy for Chronic Pain is effective for managing chronic pain in Veterans with serious mental illness?

Research has shown that Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), which participants in this trial may receive, can help manage long-term pain. Studies have found that CBT-CP not only reduces pain but also alleviates related issues like depression and anxiety. It improves therapists' skills and outcomes for veterans, making it particularly beneficial for them. Another study suggested that CBT-CP can change negative thinking and enhance overall mental health. Overall, evidence indicates that CBT-CP can be helpful for people dealing with chronic pain and mental health issues. ^{2 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 like schizophrenia or bipolar disorder who also suffer from chronic pain. Participants must be adults enrolled in VA Maryland Health Care System outpatient programs, able to give informed consent, and have a certain level of pain severity. Those with severe substance use issues or current acute pain conditions that would hinder participation are excluded.

Inclusion Criteria

Have regular access to a telephone

I am able to understand and sign the consent form.

My medical records show a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder.

Exclusion Criteria

You are using drugs or alcohol in a way that would make it hard for you to take part in the study or would need more medical attention.

I cannot walk a city block due to pain or limited mobility.

I have been involved in therapy for chronic pain.

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) over 12 sessions, including an initial assessment, 10 content-specific sessions, and a booster session

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including WHYMPI, WHODAS 2.0, VR-36, and WHOQOL-BREF

10 weeks

Data Collection and Evaluation

Feasibility of collecting EMA data and process evaluation to optimize CBT-CP for future trials

Ongoing throughout the trial

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Chronic Pain

Trial Overview

The study tests the suitability and effectiveness of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) among Veterans with serious mental illness. It aims to improve nonpharmacological management of chronic pain and understand its relationship with psychiatric symptoms.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy for Chronic Pain 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 and Wellness Active Control 1 Intervention

Health \& Wellness 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.

Cognitive Behavioral Therapy for Chronic Pain is already approved in United States for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Chronic Pain for:

• Chronic pain management in veterans with serious mental illness

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

VA Maryland Health Care System

Collaborator

Trials

11

Recruited

740+

Published Research Related to This Trial

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 effective in addressing various factors that influence chronic low back pain (CLBP), but the term itself is too broad for future research, necessitating specific definitions based on the problems being addressed.

Despite its proven effectiveness, CBT is not widely implemented in clinical practice for CLBP, highlighting the need for early adoption and a public health approach to operationalize these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the Role of Cognitive Behavioral Therapy in Treating Chronic Low Back Pain: An Overview. Hanscom, DA., Brox, JI., Bunnage, R.[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 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]

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 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 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]

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Integrated cognitive behavioral therapy for chronic pain

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