Cognitive Behavioral Therapy for Serious Mental Illness-related Chronic Pain

(CPSMI Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Letitia Travaglini, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Chronic pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic pain leads to poorer mental health and physical functioning, and represents a critical obstacle to rehabilitation and recovery. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to: a) evaluate nonpharmacological pain management strategies in this population, and b) examine directional relations between chronic pain and SMI symptoms. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI, and b) better assessing the complex relation between chronic pain and psychiatric symptoms and their impact on functioning. Results from this study will inform us as to whether CBT-CP is feasible to implement, acceptable to Veterans with SMI, and worth examining in its standard or in an optimized form in a larger clinical trial.

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.

What data supports the idea that Cognitive Behavioral Therapy for Serious Mental Illness-related Chronic Pain is an effective treatment?

The available research shows that Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is effective in managing chronic pain. One study highlights that CBT-CP is a successful treatment for chronic pain and is especially important for people in rural areas who have less access to healthcare. Another study mentions that CBT has been a key treatment for chronic pain for many years, helping improve pain and related issues. Additionally, CBT has been adapted for different groups, like children and older adults, and can be delivered in various ways, such as online or over the phone, making it more accessible. Overall, these studies suggest that CBT-CP is a valuable treatment option for chronic pain. ^{1 2 3 4 5}

What safety data exists for Cognitive Behavioral Therapy for Chronic Pain?

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is considered a safe and effective treatment for chronic pain. It is an alternative to opioid analgesics and has been shown to be effective in various settings, including primary care. The therapy is well-supported by evidence, although it is underused due to accessibility issues. No specific safety concerns are highlighted in the available research, indicating it is generally safe for use. ^{1 2 3 6 7}

Is Cognitive Behavioral Therapy for Chronic Pain a promising treatment?

Yes, Cognitive Behavioral Therapy for Chronic Pain is a promising treatment. It is effective in improving pain and related issues, and it can be adapted for different groups, including children and older adults. It is also being made more accessible through online and phone options, which is important for people in areas with limited healthcare services. ^{1 2 3 5 8}

Eligibility Criteria

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.

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Chronic Pain (Behavioral Intervention)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

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

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

VA Maryland Health Care System Collaborator

References

1. 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] Although cognitive behavioral therapy is an effective intervention for chronic pain, it is a lengthy treatment typically applied only in specialty care settings. The aim of this project was to collect preliminary effectiveness data for Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP), an abbreviated, modular form of treatment designed for use in primary care.

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] Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use.

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

Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. [2021] Increasing evidence supports the use of cognitive-behavioral therapy (CBT) for patients with chronic pain.

4. 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] Cognitive behavioural therapy (CBT) has been useful in the treatment of chronic pain conditions for many years. Given the increasing number of persons with chronic pain and associated psychosocial problems, the development and implementation of effective interventions based on CBT is warranted.

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

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. [2022] Over the past three decades, cognitive-behavioral therapy (CBT) has become a first-line psychosocial treatment for individuals with chronic pain. Evidence for efficacy in improving pain and pain-related problems across a wide spectrum of chronic pain syndromes has come from multiple randomized controlled trials. CBT has been tailored to, and found beneficial for, special populations with chronic pain, including children and older adults. Innovations in CBT delivery formats (e.g., Web-based, telephone-delivered) and treatments based on CBT principles that are delivered by health professionals other than psychologists show promise for chronic pain problems. This article reviews (a) the evidence base for CBT as applied to chronic pain, (b) recent innovations in target populations and delivery methods that expand the application of CBT to underserved populations, (c) current limitations and knowledge gaps, and (d) promising directions for improving CBT efficacy and access for people living with chronic pain.

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] Cognitive behavioral therapy for chronic pain (CBT-CP) is a safe and effective alternative to opioid analgesics. Because CBT-CP requires multiple sessions and therapists are scarce, many patients have limited access or fail to complete treatment.

7. England pubmed.ncbi.nlm.nih.gov

Defining the Role of Cognitive Behavioral Therapy in Treating Chronic Low Back Pain: An Overview. [2020] Study Design Narrative review of the literature. Objectives Determine if the term cognitive behavioral therapy (CBT) is useful in clinical care and research. What literature supports these variables being relevant to the experience of chronic pain? What effects of CBT in treating these factors have been documented? What methods and platforms are available to administer CBT? Methods Chronic low back pain (CLBP) is a complex neurologic disorder with many components. CBT refers to a broad family of therapies that address both maladaptive thoughts and behaviors. There are several ways to deliver it. CLBP was broken into five categories that affect the perception of pain, and the literature was reviewed to see the effects of CBT on these variables. Results The term cognitive behavioral therapy has little use in future research because it covers such a wide range of therapies. CBT should always be defined by the problem it is intended to solve. The format and method of delivery should be defined because they have implications for outcomes. They are readily available even at the primary care level. The effectiveness of CBT is unquestioned regarding its effectiveness in treating each of the variables that affect CLBP. It is unclear why it is not more widely implemented. Conclusions CBT represents a family of therapies that are effective for a wide range of problems, many of which coexist with and influence CLBP. Each of the variables can be improved with focused CBT. Early, widespread adoption of CBT in treating and preventing CLBP is recommended. Future research and clinical care should focus on strategies to operationalize these well-documented treatments utilizing a public health approach.

8. England pubmed.ncbi.nlm.nih.gov

Pain catastrophizing as a treatment process variable in cognitive behavioural therapy for adults with chronic pain. [2021] Interdisciplinary cognitive behavioural therapy (CBT) for chronic pain is effective at improving function, mood and pain interference among individuals with disabling chronic pain. Traditionally, CBT assumes that cognitive change is an active therapeutic ingredient in the determination of treatment outcome. Pain catastrophizing, a cognitive response style that views the experience of pain as uncontrollable, permanent and destructive, has been identified as an important maladaptive cognition which contributes to difficulties with the management of chronic pain. Consequently, pain catastrophizing is commonly targeted in CBT for chronic pain.