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

47 Participants Needed

Trial Summary

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

Research shows that Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is effective in improving pain and related issues across various chronic pain conditions. It has been successfully adapted for different populations, 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}

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 4 6 7}

Is Cognitive Behavioral Therapy for Chronic Pain safe for humans?

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is considered a safe alternative to opioid pain medications, as noted in research studies. ^{1 2 4 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 4 8}

How is Cognitive Behavioral Therapy for Chronic Pain different from other treatments for chronic pain?

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is unique because it focuses on changing the way people think about and respond to pain, which can help improve mood and reduce pain interference. It is also accessible through remote formats like telehealth, making it more available to people in rural or underserved areas. ^{1 2 3 5 8}

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.

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 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

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

Treatment Details

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.

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

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+

Findings from Research

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 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]

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 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]

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]

References

1. 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]

2. 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]

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

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

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

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

5. 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]

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

Defining the Role of Cognitive Behavioral Therapy in Treating Chronic Low Back Pain: An Overview. [2020]

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

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